Local Infiltrative Anesthetic Effect of Tramadol Compared to Lidocaine for Excision of Cutaneous Lesions: Pilot Randomized, Double-Blind Clinical Study

2012 ◽  
Vol 16 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Despoina Kakagia ◽  
Theodosia Vogiatzaki ◽  
Savvas Eleftheriadis ◽  
Gregory Trypsiannis ◽  
Christos Iatrou
Keyword(s):  
Injection Site ◽  
Postoperative Analgesia ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Demographic Data ◽  
Randomized Study ◽  
Cutaneous Lesions ◽  
Double Blind ◽  
Lidocaine Group ◽  
Pain Scores

Background: In this double-blind, randomized study, the efficacy of tramadol, an atypical opioid, was tested versus lidocaine in excision of cutaneous lesions of the face. Methods: Eighty-eight patients were randomly assigned to receive either 2 mg/kg tramadol 2% plus adrenaline 1:200,000 (group T, n = 46) or 3 mg/kg lidocaine 2% plus adrenaline 1:200,000 (group L, n = 42) for excision of cutaneous lesions. Pain at the injection site, 2 and 20 minutes postinjection and 3, 6, and 12 hours postoperatively, was monitored on a 0 to 10 numerical rating scale (NRS). Irritation at the injection point and the duration of postoperative analgesia were also recorded. Results: There were no significant differences in demographic data, topography, size of the lesions removed, and operative time between the two groups. A tendency toward lower injection NRS pain scores was observed in group L compared to group T (p = .064). No statistically significant differences between the two groups were found at 2 and 20 minutes postinjection (p = .741 and p = .142, respectively); however, pain scores were significantly higher in group L at 3, 6, and 12 hours postoperatively (all p < .001). Erythema at the injection site was observed in nine group T and two group L patients (p = .076). No postoperative analgesics were required in the tramadol group of patients, whereas acetaminophen with or without codeine was administered in all but five lidocaine group patients during the first 12 hours. Conclusion: Tramadol may be used as a reliable local anesthetic agent, providing longer postoperative analgesia compared to lidocaine; however, it bears a higher incidence of irritation at the injection site.

scholarly journals The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: a randomized clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Joshan Lal Bajracharya ◽  
Asish Subedi ◽  
Krishna Pokharel ◽  
Balkrishna Bhattarai
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Cholecystectomy ◽  
Postoperative Analgesia ◽  
Multimodal Analgesia ◽  
Opioid Consumption ◽  
Double Blind ◽  
Lidocaine Group ◽  
Pain Scores ◽  
Sedation Scores ◽  
Vas Scores

Abstract Background As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. Methods In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5 mg/kg at induction followed by an infusion (1.5 mg/ kg/h) or IV bolus of esmolol 0.5 mg/kg at induction followed by an infusion (5–15 μg/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ≤3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24 h postoperatively. Results Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0–1.5) mg compared to 1.5 (1–2) mg in lidocaine group (p = 0.27). The median pain scores at various time points were similar between the two groups (p > 0.05). More patients receiving lidocaine were sedated in the post-anesthesia care unit (PACU) than those receiving esmolol (p < 0.05); however, no difference was detected later. Conclusion Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24 h after surgery. Patients receiving lidocaine were more sedated during their stay in PACU than those receiving esmolol. Trial registration ClinicalTrials.gov- NCT02327923. Date of registration: December 31, 2014.

Oral Flurbiprofen Spray for Posttonsillectomy Pain

2016 ◽  
Vol 155 (1) ◽  
pp. 166-172 ◽  
Author(s):  
Togay Muderris ◽  
Fatih Gul ◽  
Gokhan Yalciner ◽  
Mehmet Ali Babademez ◽  
Sami Bercin ◽  
...  
Keyword(s):  
Placebo Group ◽  
Rating Scale ◽  
Demographic Data ◽  
Double Blind ◽  
Pain Scores ◽  
Significant Difference ◽  
Lower Pain ◽  
Numeric Pain Rating Scale ◽  
Rating Scale Data ◽  
Posttonsillectomy Pain

Objective Tonsillectomy is still one of the most common surgical procedures, but there exists no standard guideline for pain management after tonsillectomy. Our aim is to determine whether oral spray of flurbiprofen reduces pain and has an influence on other morbid outcomes following tonsillectomy. Study Design Prospective, double-blind, randomized, placebo controlled. Setting Patients at Ataturk Training and Research Hospital, Ankara, Turkey. Subjects and Methods This study was performed on 84 patients (45 in flurbiprofen group, 39 in placebo group) who underwent tonsillectomy. The patients were randomly chosen, and each used oral spray of flurbiprofen 3 times daily or placebo solution at the same regimen. Efficacy was assessed by changes in Numeric Pain Rating Scale. Data were collected at postoperative days 1, 3, 5, and 7 for pain, bleeding, and healing. Data for Mallampati scores were also collected. Results There were no significant difference between groups with respect to the demographic data. The flurbiprofen group had statistically significant lower pain scores at days 1, 3, 5, and 7 ( P = .000, P = .002, P = .001, P = .000, respectively). On days 3 and 7, pain scores were significantly different between different Mallampati groups ( P = .049, P = .015, respectively). The flurbiprofen group required less analgesic than the placebo group during the study period on days 1, 3, 5, and 7 ( P = .001, P = .001, P = .03, P = .001, respectively). Healing and side effects were not significantly different between the groups. Conclusion In this study, topical use of flurbiprofen may reduce posttonsillectomy pain without any evidence of additional complications.

scholarly journals The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: A randomized clinical trial

2019 ◽  
Author(s):  
Joshan Lal Bajracharya ◽  
Asish Subedi ◽  
Krishna Pokharel ◽  
Balkrishna Bhattarai
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Cholecystectomy ◽  
Postoperative Analgesia ◽  
Multimodal Analgesia ◽  
Opioid Consumption ◽  
Double Blind ◽  
Lidocaine Group ◽  
Pain Scores ◽  
Sedation Scores ◽  
Vas Scores

Abstract Background: As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. Methods: In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5 mg/kg at induction followed by an infusion (1.5 mg/ kg/hour) or IV bolus of esmolol 0.5 mg/kg at induction followed by an infusion (5-15 µg/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ≤ 3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24 hours postoperatively. Results: Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0-1.5) mg compared to 1.5 (1-2) mg in lidocaine group ( p =0.27). The median pain scores at various time points were similar between the two groups ( p >0.05). More patients receiving lidocaine were sedated in the post-anesthesia care unit (PACU) than those receiving esmolol (p<0.05); however, no difference was detected later. Conclusion: Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24 hours after surgery. Patients receiving lidocaine were more sedated during their stay in PACU than those receiving esmolol.

scholarly journals COMPARISON OF ULTRASOUND-GUIDED THORACIC PARAVERTEBRAL AND PECTORALIS INTERFASCIAL PLANE BLOCK FOR MODIFIED RADICAL MASTECTOMY

2021 ◽  
Vol 9 (11) ◽  
pp. 73-79
Author(s):  
Kalyani Nilesh Patil ◽  
◽  
Shalini Pravin Sardesai ◽  
Poonam Ghodki ◽  
Rajlaxmi Menghal ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Postoperative Analgesia ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Randomized Study ◽  
Radical Mastectomy ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Modified Radical Mastectomy ◽  
Ultrasound Guided

Aims and Objectives : To compare the efficacy of ultrasound-guided thoracic paravertebral block(TPVB) and ultrasound-guided pectoralis interfascial plane (PECS) block for Modified Radical Mastectomy (MRM). The primary objectives were to compare duration of post-operative analgesia and total post-operative analgesic consumption while the secondary objectives were to compare dermatomal spread, intraoperative anaesthesia requirement and patient satisfaction. Materials And Methods: Sixty female patients of American Society of Anaesthesiologists (ASA) physical status I and II, undergoing MRM under general anaesthesia, were randomly recruited to receive ultrasound-guided TPVB (Group T) or ultrasound-guided PECS block (Group P) with 25ml of 0.25% bupivacaine, in a prospective, observer-blinded, randomized study. Data was statistically analysed using Statistical Package for Social Sciences (SPSS) version 21.0. Categorical variables were compared using the Chi-square test or Fishers exact probability test continuous variables compared using unpaired t-test or Mann-Whitney U test. Results: All demographic variables were comparable. Intraoperative fentanyl consumption was lower in patients who received PECS block (72.50+27.35) than those who received TPVB (104.17+46.92) (p=0.0023). NRS was comparable in both groups till 2 hours post operatively. However, from 4 hours onwards, till 18 hours the Numerical Rating Scale (NRS) was significantly higher in TPVB group. Dermatomal spread was more extensive and postoperative analgesia requirement was lower in Group P. Patient satisfaction was comparable in both groups. Conclusion: PECS block is associated with superior postoperative analgesia and reduced analgesic requirement. The cranial dermatomal spread was better and intraoperative opioid requirement was less with PECS block.

scholarly journals The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: A randomized clinical trial

2019 ◽  
Author(s):  
Joshan Lal Bajracharya ◽  
Asish Subedi ◽  
Krishna Pokharel ◽  
Balkrishna Bhattarai
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Cholecystectomy ◽  
Postoperative Analgesia ◽  
Multimodal Analgesia ◽  
Opioid Consumption ◽  
Double Blind ◽  
Lidocaine Group ◽  
Pain Scores ◽  
Sedation Scores ◽  
Vas Scores

Abstract Background: As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia, but are not widely used. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. Methods: In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5 mg/kg at induction followed by an infusion (1.5 mg/ kg/hour) or IV bolus of esmolol 0.5 mg/kg at induction followed by an infusion (5-15 µg/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ≤ 3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24 hours postoperatively. Results: Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0-1.5) mg compared to 1.5 (1-2) mg in lidocaine group ( p =0.27). The median pain scores at various time points were similar between the two groups ( p >0.05). Sedation scores were higher in patients receiving lidocaine than in those receiving esmolol up to 30 min in post-anesthesia care unit (PACU; p<0.05); however, no difference was detected later. Conclusion: Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24 hours after surgery. Patients receiving lidocaine were more sedated up to 30 min in PACU than those receiving esmolol.

scholarly journals The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: A randomized clinical trial

2019 ◽  
Author(s):  
Joshan Lal Bajracharya ◽  
Asish Subedi ◽  
Krishna Pokharel ◽  
Balkrishna Bhattarai
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Cholecystectomy ◽  
Postoperative Analgesia ◽  
Multimodal Analgesia ◽  
Opioid Consumption ◽  
Double Blind ◽  
Lidocaine Group ◽  
Pain Scores ◽  
Sedation Scores ◽  
Vas Scores

Abstract As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. Methods: In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5 mg/kg at induction followed by an infusion (1.5 mg/ kg/hour) or IV bolus of esmolol 0.5 mg/kg at induction followed by an infusion (5-15 µg/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ≤ 3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24 hours postoperatively. Results: Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0-1.5) mg compared to 1.5 (1-2) mg in lidocaine group ( p =0.27). The median pain scores at various time points were similar between the two groups ( p >0.05). More patients receiving lidocaine were sedated in the post-anesthesia care unit (PACU) than those receiving esmolol (p<0.05); however, no difference was detected later. Conclusion: Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24 hours after surgery. Patients receiving lidocaine were more sedated during their stay in PACU than those receiving esmolol.

scholarly journals The Efficacy of Programmed Intermittent Epidural Bolus for Postoperative Analgesia after Open Gynecological Surgery: A Randomized Double-Blinded Study

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Shiho Satomi ◽  
Nami Kakuta ◽  
Chiaki Murakami ◽  
Yoko Sakai ◽  
Katsuya Tanaka ◽  
...  
Keyword(s):  
Epidural Anesthesia ◽  
Postoperative Analgesia ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Analgesic Efficacy ◽  
Gynecological Surgery ◽  
Double Blind ◽  
Continuous Epidural Infusion ◽  
Scale Scores ◽  
Numerical Rating

Background. It is well known that the programmed intermittent epidural bolus (PIEB) technique effectively provides epidural anesthesia in labor. This randomized double-blind trial compared the postoperative analgesic efficacy of PIEB with that of continuous epidural infusion (CEI) in patients undergoing gynecological surgery under combined general-epidural anesthesia. Methods. Patients undergoing open gynecological surgery under combined general-epidural anesthesia were randomized at a 1 : 1 ratio to receive PIEB or CEI. In the PIEB group, the pump delivered 4 mL ropivacaine 0.2% plus fentanyl 2 μg/mL every hour. In the CEI group, the pump delivered the same solution at a rate of 4 mL/h. In both groups, additional 4 mL boluses of ropivacaine 0.2% plus fentanyl 2 μg/mL were provided, when necessary, by patient-controlled epidural analgesia after surgery. The primary outcome was the total ropivacaine dose 40 hours after surgery. The secondary outcomes were the number of PCEA boluses and postoperative pain (evaluated on an 11-point numerical rating scale) 3, 24, and 48 hours after surgery. Results. In total, 57 patients were randomized (n=28 and 29 in the PIEB and CEI groups, resp.). The two groups differ significantly in terms of the total ropivacaine dose 40 hours after surgery (mean (standard deviation): 155.38 (4.55) versus 159.73 (7.87) mL, P=0.016). Compared to the CEI group, the PIEB group had significantly lower numerical rating scale scores 3 hours (median [lower–upper quartiles]: 0 [0–0.5] versus 3 [0–5.5], P=0.002), 24 hours (1 [0–2] versus 3 [1–4], P=0.003), and 48 hours (1 [0–2] versus 2 [2–3.5], P=0.002) after surgery. Conclusion. PIEB was better than CEI in terms of providing postoperative analgesia after open gynecological surgery under combined general-epidural anesthesia.

scholarly journals The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: A randomized clinical trial

2019 ◽  
Author(s):  
Joshan Lal Bajracharya ◽  
Asish Subedi ◽  
Krishna Pokharel ◽  
Balkrishna Bhattarai
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Cholecystectomy ◽  
Postoperative Analgesia ◽  
Multimodal Analgesia ◽  
Opioid Consumption ◽  
Double Blind ◽  
Lidocaine Group ◽  
Pain Scores ◽  
Sedation Scores ◽  
Vas Scores

Abstract Background: As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia, but are not widely used. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. Methods: In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5 mg/kg at induction followed by an infusion (1.5 mg/ kg/hour) or IV bolus of esmolol 0.5 mg/kg at induction followed by an infusion (5-15 µg/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ≤ 3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24 hours postoperatively. Results: Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0-1.5) mg compared to 1.5 (1-2) mg in lidocaine group ( p =0.27). The median pain scores at various time points were similar between the two groups ( p >0.05). Sedation scores were higher in patients receiving lidocaine than in those receiving esmolol up to 30 min in post-anesthesia care unit (PACU; p<0.05); however, no difference was detected later. Conclusion: Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24 hours after surgery. Patients receiving lidocaine were more sedated up to 30 min in PACU than those receiving esmolol.

scholarly journals The effect of pre-operative high doses of methylprednisolone on pain management and convalescence after total hip replacement in elderly: a double-blind randomized study

2020 ◽  
Author(s):  
Artur Gądek ◽  
Henryk Liszka ◽  
Małgorzata Zając
Keyword(s):  
Single Dose ◽  
Inflammatory Markers ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Opioid Analgesic ◽  
Randomized Study ◽  
Intensity Level ◽  
Double Blind ◽  
Total Hip ◽  
Analgesic Agents

Abstract Purpose The aim of the study was to assess whether administration of a single dose of methylprednisolone in the group patients above 65 years of age will be effective in complex analgesic management after total hip arthroplasty (THA). Methods Seventy-seven patients above 65 years old were double-blind randomized into two: the study and controls groups. Pre-operatively, the study group received as a single dose of 125 mg intravenous methylprednisolone, while the others saline solution as placebo. Peri-operatively, all the patients were administered opioid and nonopioid analgesic agents. We measured the levels of inflammatory markers (leukocytosis, C-reactive protein—CRP), pain intensity level (visual analog scale—VAS; numerical rating scale—NRS), the life parameters, and noted complications. Results Following administration of methylprednisolone were significantly lower levels of CRP on all the four post-operative days; leukocytosis on the second day; the VAS/NRS score at rest after six, 12, and 18 hours post-operatively, diminished the dose of parenteral opioid preparations (oxycodone hydrochloride), the duration of analgesia by peripheral nerve block was significantly higher as compared with the placebo group (p < 0.000001). No infectious complications were noted; there was one patient who developed post-operative delirium. Conclusion A single dose of methylprednisolone significantly reduces the level of post-operative pain at rest on the day of THA in the group patients above 65 years of age, decreases the dose of opioid analgesic agents, and significantly decreases the level of inflammatory markers, without infectious processes.

A randomized, double-blind study of “Scrambler” therapy versus sham for painful chemotherapy-induced peripheral neuropathy (CIPN).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9635-9635 ◽  
Author(s):  
Toby Christopher Campbell ◽  
Amit J Nimunkar ◽  
Janet Retseck ◽  
Jens C. Eickhoff ◽  
Miroslav Backonja ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Post Treatment ◽  
Double Blind Study ◽  
Small Pilot Study ◽  
Double Blind ◽  
Arm Pain ◽  
Pain Scores ◽  
Secondary Endpoints ◽  
Scrambler Therapy

9635 Background: CIPN is a debilitating, dose-limiting toxicity. The MC5A is a non-invasive electro-analgesia device delivering “Scrambler Therapy,” which has shown benefit for painful CIPN in uncontrolled studies. No sham-controlled trials of MC5A have been performed. Methods: Eligible patients included adults with neuropathic pain (NP) for > 6 months, pain scores ≥4/10 numerical rating scale (NRS), and no history of diabetes or other peripheral neuropathies. Patients received up to 10 daily sessions of 50 minutes with either MC5A or a novel active sham device constructed to deliver a just perceptible electrical sensation. Sham output is neither a TENS nor MC5A and is designed to be nontherapeutic. Active and sham treatments were applied to the affected limbs. 14 patients were randomized with no baseline differences. Patients and evaluators were blinded to study arm. Pain was measured before, daily during, after and 3 months post-treatment (verbal NRS). The primary endpoint was change in pain. Secondary endpoints included quantitative neurosensory testing (QST), validated patient-report measures, and cytokines. Results: There were 7 patients in each arm. The table shows changes in pain scores pre- and post-treatment by day and group. There was no difference between arms and no arm x day interaction. There was no significant day or arm effect for the function sub scales. Conclusions: In a small pilot study, MC5A was not significantly different from sham therapy for the primary outcome. The sham is feasible and provides a mechanism for future controlled studies with MC5A. Secondary endpoints, e.g. QST are forthcoming. Clinical trial information: NCT01261780. [Table: see text]

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