scholarly journals The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: A randomized controlled trial

2020 ◽  
Author(s):  
Jie Fang ◽  
Yuncen Shi ◽  
Fang Du ◽  
Zhanggang Xue ◽  
Jing Cang ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Nerve Block ◽  
Pain Therapy ◽  
Controlled Trial ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Single Shot ◽  
Clinical Trial Registry ◽  
Patient’S Satisfaction ◽  
Dexamethasone Group

Abstract Background：Rebound pain after single shot nerve block challenges the real benefit of this technique. We aimed to investigate whether perineural dexamethasone addition decreased the incidence of rebound pain after a single shot nerve block.Methods：We randomly allocated 132 patients scheduled for open reduction, and internal fixation of upper extremity closed fracture under single-shot peripheral nerve block and sedation into two groups. Patients in the dexamethasone group receiving nerve block with 0.375% ropivacaine and 8 mg dexamethasone while those in the control group received ropivacaine only. Sixty-three cases in the dexamethasone group and 60 cases in the control group were analyzed for the incidence of rebound pain in 48 h after the block administration. The primary outcome was the incidence of rebound pain in 48 h after the block administration. Secondary outcomes included the self-reported highest NRS score, pain intensity at 8h, 12h, 24h, 48h after the block, sufentanil consumption, sleep quality on the night of surgery, patient’s satisfaction to the pain therapy, blood glucose at 6h after the block, pain and paresthesia at 30 days after surgery.Results: The incidence of rebound pain was significantly lower in the dexamethasone group (7[11.1%] of 63 patients) than that in the control group (28[48.8%] of 60 patients; Relative risk (RR) is 0.238, 95% CI 0.113-0.504,p=0.001). Dexamethasone decreased the opioid consumption in 24 h after the surgery (p<0.001), improved the sleep quality score on the night of surgery(p=0.01) and satisfaction to the pain therapy(p=0.001). Multivariate logistic regression analysis showed that only group allocation was significantly associated with the occurrence of rebound pain[OR=0.131,95%CI (0.047-0.364)].Patients in the dexamethasone group reported later onset (19.7±6.6 h vs 14.7±4.8 h since block administration, mean±SD, p<0.001) lower peak NRS score [5 (3,6) vs 8 (5,9) , median(IQR), p<0.001] compared with those in the control group.Conclusions: Perineural administration of 8mg dexamethasone reduces rebound pain after a single-shot nerve block in patients receiving ORIF of upper limb fracture.Trial registration: This study was registered in Chinese Clinical Trial Registry (ChiCTR-IPR-17011365). The study was registered on May 11th , 2017. Retrospectively registered.

scholarly journals The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: A randomized controlled trial

2020 ◽  
Author(s):  
Jie Fang ◽  
Yuncen Shi ◽  
Fang Du ◽  
Zhanggang Xue ◽  
Jing Cang ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Nerve Block ◽  
Pain Therapy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Single Shot ◽  
Dexamethasone Group ◽  
Surgery Patient

Abstract Background: Rebound pain after a single-shot nerve block challenges the real benefit of this technique. We aimed to investigate whether perineural dexamethasone addition decreased the incidence of rebound pain after a single-shot nerve block.Methods: We randomly allocated 132 patients scheduled for open reduction internal fixation of an upper extremity closed fracture under single-shot peripheral nerve block and sedation into two groups. Patients in the dexamethasone group received nerve block with 0.375% ropivacaine and 8 mg dexamethasone, while those in the control group received ropivacaine only. Sixty-three patients in the dexamethasone group and 60 patients in the control group were analyzed for the incidence of rebound pain 48 h after block administration, which was the primary outcome. The secondary outcomes included the highest self-reported numeric rating scale (NRS) score, the pain intensity at 8 h, 12 h, 24 h, and 48 h after the block, sufentanil consumption, sleep quality on the night of surgery, patient satisfaction with the pain therapy, blood glucose at 6 h after the block, and pain and paresthesia at 30 days after surgery.Results: The incidence of rebound pain was significantly lower in the dexamethasone group (7 [11.1%] of 63 patients) than in the control group (28 [48.8%] of 60 patients; relative risk (RR) of 0.238, 95% CI 0.113-0.504, p=0.001). Dexamethasone decreased opioid consumption 24 h after surgery (p<0.001) and improved the sleep quality score on the night of surgery (p=0.01) and satisfaction with pain therapy (p=0.001). Multivariate logistic regression analysis showed that only group allocation was significantly associated with the occurrence of rebound pain[OR=0.062, 95% CI (0.015-0.256)]. Patients in the dexamethasone group reported later onset pain (19.7±6.6 h vs 14.7±4.8 h since block administration, mean±SD, p<0.001) and lower peak NRS scores [5 (3, 6) vs 8 (5, 9), median (IQR), p<0.001] than those in the control group.Conclusions: The perineural administration of 8 mg dexamethasone reduces rebound pain after a single-shot nerve block in patients receiving ORIF for an upper limb fracture.

scholarly journals The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jie Fang ◽  
Yuncen Shi ◽  
Fang Du ◽  
Zhanggang Xue ◽  
Jing Cang ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Nerve Block ◽  
Pain Therapy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Single Shot ◽  
Dexamethasone Group ◽  
Surgery Patient

Abstract Background Rebound pain after a single-shot nerve block challenges the real benefit of this technique. We aimed to investigate whether perineural dexamethasone addition decreased the incidence of rebound pain after a single-shot nerve block. Methods We randomly allocated 132 patients scheduled for open reduction internal fixation of an upper extremity closed fracture under single-shot peripheral nerve block and sedation into two groups. Patients in the dexamethasone group received nerve block with 0.375% ropivacaine and 8 mg dexamethasone, while those in the control group received ropivacaine only. Sixty-three patients in the dexamethasone group and 60 patients in the control group were analyzed for the incidence of rebound pain 48 h after block administration, which was the primary outcome. The secondary outcomes included the highest self-reported numeric rating scale (NRS) pain score, and NRS at 8, 12, 24, and 48 h after the block, sufentanil consumption, sleep quality on the night of surgery, patient satisfaction with the pain therapy, blood glucose at 6 h after the block, pain and paresthesia at 30 days after surgery. Results The incidence of rebound pain was significantly lower in the dexamethasone group (7 [11.1%] of 63 patients) than in the control group (28 [48.8%] of 60 patients [RR = 0.238, 95% CI (0.113–0.504), p = 0.001]. Dexamethasone decreased opioid consumption in 24 h after surgery (p < 0.001) and improved the sleep quality score on the night of surgery (p = 0.01) and satisfaction with pain therapy (p = 0.001). Multivariate logistic regression analysis showed that only group allocation was associated with the occurrence of rebound pain [OR = 0.062, 95% CI (0.015–0.256)]. Patients in the dexamethasone group reported later onset pain (19.7 ± 6.6 h vs 14.7 ± 4.8 h since block administration, mean ± SD, p < 0.001) and lower peak NRS scores [5 (3, 6) vs 8 (5, 9), median (IQR), p < 0.001] than those in the control group. Conclusions The perineural administration of 8 mg dexamethasone reduces rebound pain after a single-shot nerve block in patients receiving ORIF for an upper limb fracture. Trial registration This study was retrospectively registered in the Chinese Clinical Trial Registry (ChiCTR-IPR-17011365) on May 11th, 2017.

scholarly journals The effect of perineural dexamethasone on rebound pain after ropivacaine single-injection nerve block: A randomized controlled trial

2020 ◽  
Author(s):  
Jie Fang ◽  
Yuncen Shi ◽  
Fang Du ◽  
Zhanggang Xue ◽  
Jing Cang ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Nerve Block ◽  
Pain Therapy ◽  
Rating Scale ◽  
Controlled Trial ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Single Shot ◽  
Dexamethasone Group ◽  
Surgery Patient

Abstract Background: Rebound pain after a single-shot nerve block challenges the real benefit of this technique. We aimed to investigate whether perineural dexamethasone addition decreased the incidence of rebound pain after a single-shot nerve block.Methods: We randomly allocated 132 patients scheduled for open reduction internal fixation of an upper extremity closed fracture under single-shot peripheral nerve block and sedation into two groups. Patients in the dexamethasone group received nerve block with 0.375% ropivacaine and 8 mg dexamethasone, while those in the control group received ropivacaine only. Sixty-three patients in the dexamethasone group and 60 patients in the control group were analyzed for the incidence of rebound pain 48 h after block administration, which was the primary outcome. The secondary outcomes included the highest self-reported numeric rating scale (NRS) score, the pain intensity at 8 h, 12 h, 24 h, and 48 h after the block, sufentanil consumption, sleep quality on the night of surgery, patient satisfaction with the pain therapy, blood glucose at 6 h after the block, and pain and paresthesia at 30 days after surgery.Results: The incidence of rebound pain was significantly lower in the dexamethasone group (7 [11.1%] of 63 patients) than in the control group (28 [48.8%] of 60 patients; relative risk (RR) of 0.238, 95% CI 0.113-0.504, p=0.001). Dexamethasone decreased opioid consumption 24 h after surgery (p<0.001) and improved the sleep quality score on the night of surgery (p=0.01) and satisfaction with pain therapy (p=0.001). Multivariate logistic regression analysis showed that only group allocation was significantly associated with the occurrence of rebound pain[OR=0.062, 95% CI (0.015-0.256)]. Patients in the dexamethasone group reported later onset pain (19.7±6.6 h vs 14.7±4.8 h since block administration, mean±SD, p<0.001) and lower peak NRS scores [5 (3, 6) vs 8 (5, 9), median (IQR), p<0.001] than those in the control group.Conclusions: The perineural administration of 8 mg dexamethasone reduces rebound pain after a single-shot nerve block in patients receiving ORIF for an upper limb fracture.Trial registration: This study was retrospectively registered in the Chinese Clinical Trial Registry (ChiCTR-IPR-17011365) on May 11th, 2017.

scholarly journals Lung recruitment improves the efficacy of intubation-surfactant-extubation treatment for respiratory distress syndrome in preterm neonates, a randomized controlled trial

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Yong Yang ◽  
Wenkang Yan ◽  
Minyi Ruan ◽  
Lan Zhang ◽  
Jinzhen Su ◽  
...  
Keyword(s):  
Respiratory Distress Syndrome ◽  
Respiratory Distress ◽  
Distress Syndrome ◽  
Controlled Trial ◽  
Multivariate Logistic Regression Analysis ◽  
Lung Recruitment ◽  
Preterm Neonates ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Significant Difference

Abstract Background Lung recruitment is a maneuver used to decrease the length of intubation in preterm neonates. This study aimed to compare the therapeutic efficacy of lung recruitment plus intubation-surfactant-extubation (INSURE) procedure and INSURE alone for the preterm neonates with respiratory distress syndrome. Methods From 2017 to 2019, 184 preterm neonates (gestational age 24–32 weeks) with respiratory distress syndrome were enrolled and randomized into the lung recruitment group receiving lung recruitment (25 cm H2O, 15 s) plus INSURE and the control group receiving INSURE only. The primary outcome was the need for mechanical ventilation (MV) within 72 h after extubation. The secondary outcomes included duration of MV, noninvasive ventilation, total oxygen therapy, hospitalization time, and complications. Results Compared to the control group, the lung recruitment group had a significantly lower proportion of preterm neonates requiring MV within 72 h after extubation (23% vs. 38%, P = 0.025) and pulmonary surfactant administration, as well as a shorter MV duration. There was no significant difference in the incidences of complications (all P > 0.05) and in-hospital mortality (2% vs. 4%, P = 0.4) between the lung recruitment group and control group. Multivariate logistic regression analysis demonstrated that the control group had a 2.17-time higher risk of requiring MV than the lung recruitment group (AOR: 2.17, 95% CI: 1.13–4.18; P = 0.021). Compared with infants with a normotensive mother, infants with a hypertensive mother have a 2.41-time higher risk of requiring MV (AOR: 2.41, 95% CI: 1.15–5.05; P = 0.020). Conclusion Lung recruitment plus INSURE can reduce the need for MV within 72 h after extubation and did not increase the incidence of complications and mortality. Trial registration Chinese Clinical Trial Registry ChiCTR1800020125, retrospectively registered on December 15, 2018.

Perineural dexamethasone reduces rebound pain after ropivacaine single injection interscalene block for arthroscopic shoulder surgery: a randomized controlled trial

2021 ◽  
pp. rapm-2021-102795
Author(s):  
Jae Hee Woo ◽  
Hyun Jung Lee ◽  
Hye-Won Oh ◽  
Jong Wha Lee ◽  
Hee Jung Baik ◽  
...  
Keyword(s):  
Sleep Disturbance ◽  
Sleep Disturbances ◽  
Single Injection ◽  
Controlled Trial ◽  
Shoulder Surgery ◽  
Interscalene Block ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Dexamethasone Group ◽  
Arthroscopic Shoulder Surgery

Background and objectivesA single injection interscalene block (ISB) is a common regional analgesic technique in patients undergoing arthroscopic shoulder surgery. However, rebound pain after ISB resolution may reduce its overall benefit. Our primary aim was to assess whether perineural dexamethasone reduces the intensity and incidence of rebound pain in patients undergoing arthroscopic shoulder surgery under general anesthesia combined with a preoperative single injection ISB.MethodsThe patients were randomly assigned to receive single injection ISB using either 0.5% ropivacaine (control) or 0.5% ropivacaine containing 5 mg of dexamethasone. The primary outcomes were the pain score difference before and after ISB resolution, and the incidence of rebound pain. The secondary outcomes were the onset and duration of rebound pain, the presence of sleep disturbances due to postoperative pain, the first time when an analgesic was requested, and pain scores at various predefined time points.ResultsPain increase following ISB resolution was lower in the dexamethasone group compared with the control group (4.5±2.4 and 6.9±2.2, respectively, p<0.001). The incidence of rebound pain was significantly lower in the dexamethasone group compared with the control group (37.1% and 82.9%, respectively, p<0.001). The controls experienced greater sleep disturbance during the postoperative period compared with those who received ISB with perineural dexamethasone.ConclusionsPerineural dexamethasone added to ISB using ropivacaine led to a much smoother resolution of ISB, reflected in a significantly smaller increase in pain after block resolution, a lower incidence of rebound pain and a lower sleep disturbance during the first postoperative week.Trial registration numberClinical Trial Registry of Korea (KCT0004418).

scholarly journals Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034003
Author(s):  
Kun Peng ◽  
Min Zeng ◽  
Jia Dong ◽  
Xiang Yan ◽  
Dexiang Wang ◽  
...  
Keyword(s):  
Nerve Block ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Cervical Plexus ◽  
Ethics Review ◽  
Superficial Cervical Plexus Block ◽  
Cervical Plexus Block ◽  
Plexus Block

IntroductionScalp nerve block has been proven to be an alternative choice to opioids in multimodal analgesia. However, for the infratentorial space-occupying craniotomy, especially the suboccipital retrosigmoid craniotomy, scalp nerve block is insufficient.Methods and analysisThe study is a prospective, single-centre, randomised, paralleled-group controlled trial. Patients scheduled to receive elective suboccipital retrosigmoid craniotomy will be randomly assigned to the superficial cervical plexus block group or the control group. After anaesthesia induction, superficial cervical plexus nerve block will be performed under the guidance of ultrasound. The primary outcome is the cumulative consumption of sufentanil by the patient-controlled intravenous analgesia pump within 24 hours after surgery. Secondary outcomes include the cumulative consumption of sufentanil at other four time points and numerical rating scale pain severity score.Ethics and disseminationThe protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberNCT04036812

scholarly journals Thoracic Paravertebral Blockade Reduces Chronic Postsurgical Pain in Breast Cancer Patients: A Randomized Controlled Trial

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3539-3547
Author(s):  
Zeng-Mao Lin ◽  
Mu-Han Li ◽  
Feng Zhang ◽  
Xue Li ◽  
Chun-Li Shao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Controlled Trial ◽  
Cancer Surgery ◽  
Breast Cancer Surgery ◽  
Control Group ◽  
Single Shot ◽  
Randomized Controlled ◽  
Chronic Postsurgical Pain

Abstract Objective To evaluate the effect of multilevel single-shot thoracic paravertebral blockade (PVB) on the occurrence of chronic postsurgical pain (CPSP) in patients undergoing breast cancer surgery. Design A randomized controlled trial with two parallel groups. Setting A tertiary hospital. Methods Patients scheduled for breast cancer surgery were randomized to receive either ultrasound-guided multilevel single-shot PVB from T2 to T5 (the PVB group) or nothing (the control group). Surgery was then performed under general anesthesia. Patients were followed up for 12 months after surgery. The primary end point was incidence of CPSP at six months after surgery. Results A total of 218 patients were enrolled and randomized; of these, 208 and 204 completed six- and 12-month follow-up, respectively. The incidence of CPSP at six months was significantly lower in the PVB group (12.5% [13/104]) than in the control group (24.0% [25/104], relative risk = 0.52, 95% CI = 0.28–0.96, P = 0.031). Pain scores within 48 hours both at rest and with movement were lower in the PVB group than the control group (P = 0.006 and P &lt; 0.001, respectively). The percentages of patients with neuropathic pain were also lower in the PVB group than the control group at both six and 12 months after surgery (P = 0.016 and 0.028, respectively). Adverse events did not differ between groups. Conclusions For patients undergoing breast cancer surgery, multilevel single-shot PVB reduces the incidence of CPSP at six months; it also improves early postoperative analgesia and reduces neuropathic pain at six and 12 months after surgery.

scholarly journals Moderate Exercise Plus Sleep Education Improves Self-Reported Sleep Quality, Daytime Mood, and Vitality in Adults with Chronic Sleep Complaints: A Waiting List-Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-10 ◽  
Author(s):  
Carmen Gebhart ◽  
Daniel Erlacher ◽  
Michael Schredl
Keyword(s):  
Physical Exercise ◽  
Sleep Quality ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Intervention Group ◽  
Waiting List ◽  
Control Group ◽  
Sleep Education ◽  
Sleep Complaints ◽  
Chronic Sleep

Research indicates that physical exercise can contribute to better sleep quality. This study investigates the six-week influence of a combined intervention on self-rated sleep quality, daytime mood, and quality of life. A nonclinical sample of 114 adults with chronic initiating and the maintaining of sleep complaints participated in the study. The intervention group of 70 adults underwent moderate physical exercise, conducted weekly, plus sleep education sessions. Improvements among participants assigned to the intervention group relative to the waiting-list control group (n=44) were noted for subjective sleep quality, daytime mood, depressive symptoms and vitality. Derived from PSQI subscores, the intervention group reported increased sleep duration, shortened sleep latency, fewer awakenings after sleep onset, and overall better sleep efficiency compared to controls. The attained scores were well sustained and enhanced over a time that lasted through to the follow-up 18 weeks later. These findings have implications in treatment programs concerning healthy lifestyle approaches for adults with chronic sleep complaints.

scholarly journals Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Barthel Index ◽  
Controlled Trial ◽  
Survival Rates ◽  
Control Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

scholarly journals Auricular acupressure for hot flashes in patients with prostate cancer: protocol for a pilot randomized controlled trial

2020 ◽  
Author(s):  
Jianfu Zhou ◽  
Rongwu Lin ◽  
Xuehua Liu ◽  
Liguo Lv ◽  
Shusheng Wang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Pilot Study ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Preliminary Evidence ◽  
Control Group ◽  
Random Allocation ◽  
Clinical Trial Registry ◽  
Auricular Acupressure

Abstract BackgroundHot flashes, characterized by intense heat sensation and diaphoresis, are common side effects resulted from hormonotherapy in patients with prostate cancer. Cumulated studies have revealed beneficial role of acupuncture as complementary and alternative recipe for the management of hot flashes. However, little is known about the auricular acupressure (AA), a micro-acupuncture technique whose therapeutic purpose is similar with conventional acupuncture. Therefore, this current study aims to explore the effects and determine the feasibility of AA for hot flashes in patients with prostate cancer.Methods/DesignThis proposed pilot study is a two-arm parallel, single-blinded, randomized sham-controlled trial. A total of 72 participants of prostate cancer suffered with hot flashes will be recruited and randomly allocated into two groups in a 1:1 ratio. Equal randomization is conducted using a computer-generated random allocation sequence. Sheng Zhi Qi (TF2), Nei Fen Mi (CO18), Shen Men (TF4), Shen (CO10) and Pi Zhi Xia (AT4) are selected as experimental acupressure points, and five helix points (HX 8-12) are used as sham control acupressure points. Participants in the experimental group and control group will receive AA and sham-AA treatment, respectively. The duration of the treatment is 6 weeks with two sessions per week, and the follow-up period is 12 weeks. The primary outcome is Hot Flash Score (HFS). The secondary outcomes include Quality of Life (QoL), Pittsburgh Sleep Quality Index (PSQI) and Hamilton Anxiety Scale (HAS). All outcomes measurement will be conducted before and through treatment period as well as follow-up period. Safety assessment will be carried out through treatment and follow-up period.DiscussionThis pilot study will for the first time advance our knowledge on feasibility of AA in alleviating hot flashes in patients of prostate cancer and provide preliminary evidence for a further full-scale trial.Trial registrationChinese Clinical Trial Registry, ChiCTR1900026694. Registered on 19 October 2019.

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