Effect of therapeutic suggestions during general anaesthesia on postoperative pain and opioid use: multicentre randomised controlled trial

Abstract Objective To investigate the effect of therapeutic suggestions played to patients through earphones during surgery on postoperative pain and opioid use. Design Blinded randomised controlled study. Setting Five tertiary care hospitals in Germany. Participants 385 of 400 patients consecutively recruited from January to December 2018 who were to undergo surgery for 1-3 hours under general anaesthesia. In the per protocol analysis 191 patients were included in the intervention group and 194 patients in the control group. Intervention The intervention comprised an audiotape of background music and positive suggestions based on hypnotherapeutic principles, which was played repeatedly for 20 minutes followed by 10 minutes of silence to patients through earphones during general anaesthesia. Patients in the control group were assigned to a blank tape. Main outcome measures The main outcome was dose of opioid administered by patient controlled analgesia or nurse controlled analgesia within the first postoperative 24 hours, based on regular evaluation of pain intensity on a numerical rating scale (range 0-10, with higher scores representing more severe pain). Results Compared with the control group, the intervention group required a significantly (P=0.002) lower opioid dose within 24 hours after surgery, with a median of 4.0 mg (interquartile range 0-8) morphine equivalents versus 5.3 (2-12), and an effect size (Cohen’s d) of 0.36 (95% confidence interval 0.16 to 0.56). The number of patients who needed opioids postoperatively was significantly (P=0.001) reduced in the intervention group: 121 of 191 (63%, 95% confidence interval 45% to 70%) patients in the intervention group versus 155 of 194 (80%, 74% to 85%) in the control group. The number needed to treat to avoid postoperative opioids was 6. Pain scores were consistently and significantly lower in the intervention group within 24 hours after surgery, with an average reduction of 25%. No adverse events were reported. Conclusions Therapeutic suggestions played through earphones during general anaesthesia could provide a safe, feasible, inexpensive, and non-drug technique to reduce postoperative pain and opioid use, with the potential for more general use. Based on the finding of intraoperative perception by a considerable number of patients, surgeons and anaesthetists should be careful about background noise and conversations during surgery. Trial registration German Clinical Trial Register DRKS00013800.

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Perioperative Gabapentin Does Not Reduce Postoperative Delirium in Older Surgical Patients

Anesthesiology ◽

10.1097/aln.0000000000001804 ◽

2017 ◽

Vol 127 (4) ◽

pp. 633-644 ◽

Cited By ~ 18

Author(s):

Keyword(s):

Postoperative Pain ◽

Postoperative Delirium ◽

Intervention Group ◽

Group Versus ◽

Length Of Hospital Stay ◽

Treated Group ◽

Assessment Method ◽

Hospital Length Of Stay ◽

Control Group ◽

Opioid Use

Abstract Background Postoperative pain and opioid use are associated with postoperative delirium. We designed a single-center, randomized, placebo-controlled, parallel-arm, double-blinded trial to determine whether perioperative administration of gabapentin reduced postoperative delirium after noncardiac surgery. Methods Patients were randomly assigned to receive placebo (N = 347) or gabapentin 900 mg (N = 350) administered preoperatively and for the first 3 postoperative days. The primary outcome was postoperative delirium as measured by the Confusion Assessment Method. Secondary outcomes were postoperative pain, opioid use, and length of hospital stay. Results Data for 697 patients were included, with a mean ± SD age of 72 ± 6 yr. The overall incidence of postoperative delirium in any of the first 3 days was 22.4% (24.0% in the gabapentin and 20.8% in the placebo groups; the difference was 3.20%; 95% CI, 3.22% to 9.72%; P = 0.30). The incidence of delirium did not differ between the two groups when stratified by surgery type, anesthesia type, or preoperative risk status. Gabapentin was shown to be opioid sparing, with lower doses for the intervention group versus the control group. For example, the morphine equivalents for the gabapentin-treated group, median 6.7 mg (25th, 75th quartiles: 1.3, 20.0 mg), versus control group, median 6.7 mg (25th, 75th quartiles: 2.7, 24.8 mg), differed on the first postoperative day (P = 0.04). Conclusions Although postoperative opioid use was reduced, perioperative administration of gabapentin did not result in a reduction of postoperative delirium or hospital length of stay.

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Effectiveness of online tailored advice to prevent running-related injuries and promote preventive behaviour in Dutch trail runners: a pragmatic randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2016-097025 ◽

2017 ◽

Vol 52 (13) ◽

pp. 851-858 ◽

Cited By ~ 13

Author(s):

Luiz Carlos Hespanhol ◽

Willem van Mechelen ◽

Evert Verhagen

Keyword(s):

Randomised Controlled Trial ◽

Preventive Intervention ◽

Absolute Risk ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Number Needed To Treat ◽

Preventive Behaviour ◽

Randomised Controlled ◽

Tailored Advice

BackgroundTrail running is popular worldwide, but there is no preventive intervention for running-related injury (RRI).AimTo evaluate the effectiveness of adding online tailored advice (TrailS6) to general advice on (1) the prevention of RRIs and (2) the determinants and actual preventive behaviour in Dutch trail runners.MethodsTwo-arm randomised controlled trial over 6 months. 232 trail runners were randomly assigned to an intervention or control group. All participants received online general advice on RRI prevention 1 week after baseline. Every 2 weeks, participants in the intervention group received specific advice tailored to their RRI status. The control group received no further intervention. Bayesian mixed models were used to analyse the data.ResultsTrail runners in the intervention group sustained 13% fewer RRIs compared with those in the control group after 6 months of follow-up (absolute risk difference −13.1%, 95% Bayesian highest posterior credible interval (95% BCI) −23.3 to −3.1). A preventive benefit was observed in one out of eight trail runners who had received the online tailored advice for 6 months (number needed to treat 8, 95% BCI 3 to 22). No significant between-group difference was observed on the determinants and actual preventive behaviours.ConclusionsOnline tailored advice prevented RRIs among Dutch trail runners. Therefore, online tailored advice may be used as a preventive component in multicomponent RRI prevention programmes. No effect was observed on determinants and actual preventive behaviours.Trial registration numberThe Netherlands National Trial Register (NTR5431).

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Postoperative Analgesia for Haemorrhoid Surgery

Anaesthesia and Intensive Care ◽

10.1177/0310057x8301100106 ◽

1983 ◽

Vol 11 (1) ◽

pp. 27-30 ◽

Cited By ~ 16

Author(s):

D. A. Pybus ◽

B. E. D'Bras ◽

G. Goulding ◽

H. Liberman ◽

T. A. Torda

Keyword(s):

Postoperative Pain ◽

General Anaesthesia ◽

Postoperative Analgesia ◽

Normal Saline ◽

Morphine Sulphate ◽

Control Group ◽

Treatment Groups ◽

Number Of Patients ◽

Caudal Analgesia ◽

The Mean

Seventy patients undergoing haemorrhoidectomy under general anaesthesia were randomly allocated to one of five treatment groups in order to compare the effectiveness of various caudal agents in the control of postoperative pain. Four groups were given a caudal injection of either 2% lignocaine, 0.5% bupivacaine, 2% lignocaine + morphine sulphate 4 mg or normal saline + morphine sulphate 4 mg, while the fifth (control) group did not receive an injection. The number of patients requiring postoperative opiates was significantly higher in the lignocaine group than in the morphine (p <0.05) and morphine-lignocaine (p <0.05) groups. No agent significantly reduced the number requiring opiates. In those who received opiates, the mean analgesic period was 228 minutes in the control group, and was significantly longer following bupivacaine (577 min, p <0.01), morphine-lignocaine (637 min, p <0.05) and morphine (665 min, p <0.01). The mean analgesic period following lignocaine (349 min) was not significantly different from control. The incidence of catheterisation was lowest in those patients who did not receive caudal analgesia.

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Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽

10.1136/bmjopen-2018-024589 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024589

Author(s):

Wen Yao Mak ◽

Loke Meng Ong ◽

Bak Leong Goh ◽

Sunita Bavanandan ◽

Lily Mushahar ◽

...

Keyword(s):

Peritoneal Dialysis ◽

Randomised Controlled Trial ◽

Continuous Ambulatory Peritoneal Dialysis ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Open Label ◽

Randomised Controlled ◽

End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

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Role of Preoperative Pregabalin in Reducing Inhalational Anaesthetic Requirements in Abdominal Hysterectomy: Randomized Controlled Trial

10.21203/rs.2.183/v1 ◽

2019 ◽

Author(s):

Ahmed Abdalla Mohamed ◽

Gehan Helmy Ibrahim ◽

Nesrine Abd Elrahman El Refai ◽

Tamer Mousaad Abdelhamid Gamaleldin ◽

Reham Ali Abdelrahman Abdelrahman ◽

...

Keyword(s):

Postoperative Pain ◽

General Anaesthesia ◽

Bispectral Index ◽

Total Abdominal Hysterectomy ◽

Abdominal Hysterectomy ◽

Neurological Dysfunction ◽

Hypoglycemic Agents ◽

Controlled Study ◽

Control Group ◽

Rescue Analgesia

Abstract Background: preoperative oral pregabalin controls postoperative pain & decreases anesthetic requirements in total intravenous anaesthesia . In this study, we hypothesized that preoperative pregabalin reduces inhaled isoflurane requirements. Methods: Study was conducted in a university hospital, included 50 women (18-60 yrs.), ASA I or II, admitted to undergo elective abdominal hysterectomy under general anaesthesia. Time of study: June to September 2017. Exclusion criteria were allergy or hypersensitivity to pregabalin; patients on calcium channel blockers, antiepileptic drugs, antidepression drugs, any analgesics or sedatives, or oral hypoglycemic agents; and patients with severe cardiovascular, renal, hepatic or neurological dysfunction. Interventions: giving either oral pregabalin 150 mg or placebo to patients of both groups. Primary outcome measures: inhaled isoflurane requirements to maintain haemodynamics ± 20% of baseline& bispectral index (BIS) of 40 - 60, measured using MAQUET Flow-I anaesthetic machine. Secondary outcomes : attenuation of pressor response to intubation, postoperative pain, first time for rescue analgesia, total anaglesics and adverse effects. Results: Isoflurane consumption was significantly less in pregabalin group (7.80 ± 1.27ml h -1) versus (12.27 ± 2.49 ml h-1) in control group, (P= 0.00). Better haemodynamic stability was in pregabalin group after intubation. First postoperative hour :the mean VAS score was significantly higher in control group (7.10 ± 1.20) compared to pregabalin group (4.50 ± 1.70), P<0.001. All patients in control group received pethidine intramuscular. More patients in pregabalin group suffered dizziness. Conclusion: preoperative pregabalin 150 mg ,1 h before total abdominal hysterectomy has an inhaled anaesthetic-sparing effect, maintain haemodynamics and optimizes postoperative analgesia. Keywords: Gabapentinoids, Pregabalin; Inhalation Anaesthetics, Isoflurane; Monitoring, Bispectral Index; Surgery, Abdominal Hysterectomy Objectives: We aimed to investigate the effectiveness and safety of preoperative oral pregabalin 150 mg in women undergoing elective total abdominal hysterectomy under general anaesthesia. Design: A prospective, randomized, double-blind, controlled study. Trial Registry Number: ClinicalTrials.gov: NCT 03302208

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RANDOMISED CONTROLLED STUDY TO EVALUATE THE EFFECTS OF NITROGLYCERINE SUBLINGUAL SPRAY ON TRACHEAL EXTUBATION RESPONSE IN NORMOTENSIVE PATIENTS UNDERGOING SURGERIES UNDER GENERAL ANAESTHESIA

10.36106/ijsr/1600746 ◽

2020 ◽

pp. 1-6

Author(s):

Surendra Kumar Raikwar ◽

Anil Kori* ◽

Aditya Agarwal

Keyword(s):

Stress Response ◽

General Anaesthesia ◽

Tracheal Extubation ◽

Controlled Study ◽

Control Group ◽

Pain Anxiety ◽

Arterial Blood ◽

Variable Success ◽

Related Stress ◽

Randomised Controlled

Tracheal extubation is the translaryngeal removal of a tube from the trachea via the nose or mouth and associated with awakening, pain, anxiety, airway irritation which may cause a cough or difculties in breathing and may contribute to an increase in haemodynamic response (1) .Several modalities, both pharmacological and nonpharmacological have been tried to decrease this stress response with variable success. We undertook this study to assess the efcacy of NTG spray in decreasing extubation related stress response in normotensive patients undergoing elective surgeries under general anaesthesia. Material and methods : Sixty normotensive patients were included in study and randomly subdivided into two groups of 30 patients each – group N receiving NTG spray and Group C not receiving NTG spray prior to extubation. Hemodynamic stress response during extubation was noted in both the groups and compared. Result and conclusion : Extubation was associated with signicant rise in systolic, diastolic and mean arterial blood pressure and heart rate in both the groups, but this stress response was signicantly less in NTG Group as compared to control group.

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Does handwriting the name of a potential trial participant on an invitation letter improve recruitment rates? A randomised controlled study within a trial

F1000Research ◽

10.12688/f1000research.18939.1 ◽

2019 ◽

Vol 8 ◽

pp. 659 ◽

Cited By ~ 1

Author(s):

Jennifer McCaffery ◽

Alex Mitchell ◽

Caroline Fairhurst ◽

Sarah Cockayne ◽

Sara Rodgers ◽

...

Keyword(s):

Intervention Group ◽

Small Sample ◽

Controlled Study ◽

Control Group ◽

Trial Participant ◽

Invitation Letter ◽

Wide Range ◽

Study Within A Trial ◽

Secondary Outcomes ◽

Randomised Controlled

Background: Randomised controlled trials (RCTs) often fail to recruit to target, resulting in a lack of generalisability of findings. A wide range of strategies for potentially increasing recruitment have been identified; however, their effectiveness has not been established. The aim of this study within a trial (SWAT) was to evaluate the effectiveness of handwritten personalisation of an invitation letter as part of a trial recruitment pack on recruitment to a host RCT. Methods: A pragmatic, two-armed RCT was conducted, embedded within an existing falls prevention trial (OTIS) in men and women aged 65 years and over living in the community. Participants were randomised 1:1 to receive an OTIS recruitment pack containing an invitation letter on which their name was handwritten (intervention group), or one on which it was printed (control group). The primary outcome was randomisation into the host trial. Secondary outcomes related to trial eligibility and retention. Analyses were via logistic regression and Cox Proportional Hazards regression. Results: Of the 317 SWAT participants, 12 (3.8%) were randomised into the OTIS trial: 3 (handwritten: 3/159 [1.9%]; printed: 9/158 [5.7%]; difference -3.8%, 95% CI -8.0% to 0.4%). There was weak evidence, against the intervention, of a difference in the likelihood of participants being randomised into the host trial between the two groups (OR 0.32, 95% CI 0.08 to 1.20, p=0.09). There were no statistically significant differences between the intervention and control groups on any of the secondary outcomes. Conclusions: There was no evidence that personalisation of invitation letters improved recruitment to the OTIS trial. However, due to the small sample size, the results should be interpreted with caution. These findings need to be replicated across larger studies and wider populations. Registration: ISRCTN22202133.

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Breast cancer application protocol: a randomised controlled trial to evaluate a self-management app for breast cancer survivors

BMJ Open ◽

10.1136/bmjopen-2019-034655 ◽

2020 ◽

Vol 10 (7) ◽

pp. e034655

Author(s):

Andy S K Cheng ◽

Xiangyu Liu ◽

Peter H F Ng ◽

Cindy T T Kwok ◽

Yingchun Zeng ◽

...

Keyword(s):

Breast Cancer ◽

Breast Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Readiness For Change ◽

Self Management ◽

Controlled Study ◽

Control Group ◽

Problem Solving Skills ◽

Randomised Controlled

IntroductionThe eHealth technologies that are being designed for chronic disease constitute a global trend towards health assessment and self-management. However, most of these approaches tend to focus on a single symptom or problem rather than on the multiple problems that are characteristic of many of these chronic illnesses. The aim of this study is to examine the effectiveness of and adherence to a self-management application (app) that identifies multiple problem areas related to surviving breast cancer as the targeted chronic illness.Methods and analysisThis is a randomised controlled study. Eligible participants will be allocated randomly into either an intervention group or a control group at a 1:1 ratio. The intervention group will be assigned to the self-management app (‘Be-with-You’), while the control group will use a general health app (‘Sham’ app). The primary outcomes will include the differences between the two groups in their health literacy, problem-solving skills and self-management skills. The secondary outcomes will include group differences in self-efficacy, readiness for change and health-related quality of life. All of these outcomes will be measured at baseline and at 4 weeks and 12 weeks after intervention. In addition, usability of these two mobile apps will be measured at 4 weeks and 12 weeks after intervention. The planned sample size is 476.Ethics and disseminationThe Human Subjects Ethics Sub-committee of The Hong Kong Polytechnic University approved the study (HSEARS20190922001, 24 September 2019). Dissemination of findings will occur at the local, national and international levels.Trial registration numberChiCTR1900026244.

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A Multicentre Randomised Controlled Study Evaluating the Effect of a Standardised Education Programme on Quality of Life, Disease Severity, and Disease Knowledge in Patients with Moderate-To-Severe Psoriasis: The EDUPSO Study

Dermatology ◽

10.1159/000520289 ◽

2021 ◽

pp. 1-10

Author(s):

Fatma Jendoubi ◽

Stefana Balica ◽

Marie Aleth Richard ◽

Christine Chiaverini ◽

Claire Bernier ◽

...

Keyword(s):

Patient Satisfaction ◽

Intervention Group ◽

Education Programme ◽

Controlled Study ◽

Control Group ◽

Randomised Controlled Study ◽

Randomised Controlled ◽

To Receive

Background: Psoriasis is a chronic inflammatory skin disease that has a profound effect on health-related quality of life (HRQoL). Patient education programmes may help patients to gain life-long control over their chronic disease. Objective: This multicentre randomised controlled study evaluated whether a standardised multidisciplinary education programme was beneficial to psoriasis patients. Methods: Adults with moderate-to-severe psoriasis were randomly assigned (1:1) to an intervention group to receive an educational programme or to a control group to receive usual care. Randomization was stratified by previous treatment history. The primary outcome was HRQoL, assessed by scoring the Skindex-29 domains emotion, symptom, and functioning. Psoriasis severity was assessed using the psoriasis area severity index (PASI). Levels of perceived stress, patient knowledge about psoriasis, and patient satisfaction were also assessed. Follow-up evaluations were performed at 3, 6, and 12 months. Results: A total 142 patients formed the intention-to-treat population: 70 in the control group and 72 in the intervention group. Skindex component scores and the PASI were significantly lower at 3, 6, and 12 months as compared to baseline in both groups, but no significant differences were found between the groups. Knowledge about psoriasis improved significantly during follow-up amongst patients from the intervention group compared to controls (68% of correct answers vs. 56%; p < 0.01). Patient satisfaction with psoriasis management and treatment was also better in the intervention group. Conclusions: The standardised education programme did not improve HRQoL and disease severity in psoriasis, but led to a significant improvement in patient knowledge about the disease and increased patient satisfaction.

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Improving surgical patient’s knowledge about safe use of opioids: A Randomized Controlled Trial

10.21203/rs.3.rs-41224/v1 ◽

2020 ◽

Author(s):

Helen R Doherty ◽

Enoch Lam ◽

Maria Garstka ◽

Junior Chuang ◽

David Tai Wong ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Knowledge Score ◽

Controlled Study ◽

Control Group ◽

Routine Practice ◽

Opioid Use ◽

Randomized Controlled ◽

The Difference ◽

The Impact

Abstract Background Currently, it is not routine practice to provide standardized patient education for safe postoperative opioid use. The objective of our study was to evaluate the impact of an educational pamphlet for surgical patients on knowledge about safe use, proper storage, and disposal of opioids.Methods This multi-center randomized controlled study recruited 100 patients in the pre-operative clinic. Inclusion criteria were English-speaking, ≥ 18 years, able to give informed consent, and not on opioids for chronic pain or within the past 30 days. All patients completed a baseline knowledge questionnaire (maximum score 38) on opioid safety. Patients were randomized to intervention: educational pamphlet, or control: standard care (no pamphlet) group. Questionnaires were repeated immediately post-education in the intervention group, and at 15, and 30 days after surgery in both groups. The primary outcome was change in knowledge score post-education in the intervention compared to control group. Secondary outcomes were immediate post-education, 15, and 30-day score, and answering safe storage, and disposal questions correctly.Results Between groups, the post-education score immediately after the intervention was higher in the intervention vs. control group baseline 34.2 [95% CI 33.1–35.3] vs 28.3 [95% CI 26.6–29.9]; P < 0.0001). In the intervention vs control group, mean scores were higher 31.6 (95% CI 30.5–32.7) vs 29.1 (95% CI 27.9–30.2; P = .002) at 15 days, and 32.4 (95%CI 31.4–33.5) vs 30.5 (95% CI 29.2–31.7; P = .017) at 30 days. Within the intervention group, the mean score immediately post-education (34.2 [95% confidence interval (CI) 33.1–35.3]) was higher than baseline (27.8 [95% CI 26.3–29.3]); P < 0.0001. Within the intervention group, the difference in mean score versus baseline was 3.8 (95% CI 2.1–5.5) at 15 days, and 4.6 (95% CI 2.9–6.3) at 30 days, (P < 0.05 for all timepoints). For safe disposal, a correct answer was given (intervention vs control group) by 100% vs 89.7% at 30 days (P = 0.04).Conclusions Within the intervention group, there was a significant improvement in knowledge on safe opioid use immediately post-education, and retention of knowledge at 15 and 30 days postoperatively. The intervention group had better knowledge scores compared to the baseline control group, and 15 and 30 days after surgery.Trial Registration: This study was registered in clinicaltrials.gov: NCT03959787 on May 22, 2019.

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