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Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied in a randomized controlled trial. METHODS/DESIGN:This randomized sham-controlled patient- and assessor-blind pilot trial has been designed to evaluate the efficacy and safety of electroacupuncture in managing postoperative pain following nasal endoscopic surgery to treat sinusitis due to nasal polyps. Altogether, 30 participants will be randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will occur within 2?h before the operation, immediately after the operation upon arrival in the recovery ward, and once daily for 3?days. The primary outcome is the pain numerical rating scale, which will be analyzed using the area under the curve. The secondary outcome measures include heart rate and blood pressure after the operation, sleep quality during the hospital stay (actigraph), quality of recovery, and the 36-item short form health survey. This trial will use an intention-to-treat analysis. DISCUSSION:This pilot randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the management of postoperative pain. It will inform the design of a further full-scale trial. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR1900024183. Registered on 29 June 2019.

SUBMITTER: Li S

PROVIDER: S-EPMC7014590 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial.

Li Shanshan S Zhang Qing Q Yin Xuan X Yue Hongyu H Zhang Wei W Lao Lixing L Zhang Zhangjin Z Wu Huangan H Xu Shifen S

Trials 20200211 1

<h4>Background</h4>Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied in a randomized controlled trial.<h4>Methods/design</h4>This randomized sham-controlled patient- and assessor-blind pilot trial has been designed to evaluate ...[more]

PMID: 32046764

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Project description:BACKGROUND:Postoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is particularly important for patient recovery, mobility, and satisfaction. Acupuncture has been commonly used for pain management. However, its efficacy in postoperative pain control is inconclusive and health economic evaluation is limited. METHODS:A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following abdominal surgery of gynecological diseases. Patients who are eligible for laparotomy with a midline incision for gynecological neoplasia, including ovarian mass, uterine mass, and cervical lesions, will be recruited. Seventy-two participants will be randomly allocated to an acupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 h before operation, upon arrival to the ward and once daily for 5 days. The Pain Numerical Rating Scale (NRS) on the first 5 days during hospitalization will be the primary outcome and will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include frequency of rescue analgesic use during hospital stay, cumulative morphine consumption; quality of recovery as measured by time to recovery variables and the Quality of Recovery-9 (QoR-9); quality of life as measured by the Short Form-6 dimension (SF-6D) and EuroQol-5 Dimension-5 Level (EQ-5D-5 L). The incremental cost-effectiveness ratio of acupuncture vs sham acupuncture will be calculated. DISCUSSION:This study protocol provides an example of integrative medicine practice in a hospital setting for the management of postoperative pain using acupuncture treatment. The acupuncture treatment protocol, if proven to be effective, can be implemented in routine settings to play a role in postoperative pain management for patients who have undergone abdominal surgery for gynecological diseases. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02851186 . Registered on 19 July 2016.

Project description:BackgroundMaintenance of adequate peripheral perfusion during controlled hypotension is necessary for patient safety and improved surgical outcomes during controlled hypotension in nasal surgery. The hypothesis of this study was to investigate the effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion and postoperative pain in patients undergoing nasal surgery.MethodsA total of 50 patients were randomly assigned into two equal groups in this double-blind clinical study: the magnesium sulfate group; received 40 mg/kg loading dose of intravenous (IV) magnesium sulfate followed by 10-15 mg/kg/h continuous IV infusion and the labetalol group; received 0.25 mg/kg loading dose of IV labetalol followed by 0.5-1 mg/kg/h continuous IV infusion to achieve a mean arterial blood pressure (MABP) of = 55-65 mmHg. The primary outcome was to compare the effect of perioperative magnesium sulfate and labetalol infusion on peripheral perfusion during nasal surgery. The secondary outcomes were the assessment of serum lactate, postoperative pain, time to the first call for pethidine (rescue analgesic) and total pethidine consumption.ResultsPPI was comparable between the groups at baseline, intubation, and 5 min. In contrast, magnesium sulfate group had a significantly higher PPI than the labetalol group. The magnesium sulfate group had a significantly higher MABP and heart rate compared to labetalol group. The time to reach the target MABP was significantly prolonged in magnesium sulfate than the labetalol group [21.6 ± 1.7 vs 6.9 ± 1.5] min. VAS scores were significantly lower for 2 hs postoperatively in the magnesium sulfate group than the labetalol group. The time to first call of pethidine was significantly prolonged in the magnesium sulfate group compared to the labetalol group [113.1 ± 5.2 vs 28.2 ± 1.5] min.ConclusionsMagnesium sulfate maintains wider PPI and offers better postoperative pain relief compared to labetalol during induced hypotension in nasal surgery.Trial registrationInstitutional review board approval (ref: 6601/20-12-2020).Clinicaltrialgov (ref: NCT04688203 , date of registration: 29 -12-2020).

Project description:IntroductionPostoperative ileus (POI) is an inevitable complication of almost all abdominal surgeries, which results in prolonged hospitalisation and increased healthcare costs. Various treatment strategies have been developed for POI but with limited success. Electroacupuncture (EA) might be a potential therapy for POI. However, evidence from rigorous trials that evaluated the effectiveness of EA for POI is limited. Thus, the aim of this study was to examine whether EA can safely reduce the time to the first defecation after laparoscopic surgery in patients with POI.Methods and analysisThis multicentre randomised sham-controlled trial will be conducted in four hospitals in China. A total of 248 eligible participants with colorectal cancer who will undergo laparoscopic surgery will be randomly allocated to an EA group and a sham EA group in a 1:1 ratio. Treatment will be performed starting on postoperative day 1 and continued for four consecutive days, once per day. If the participant is discharged within 4 days after surgery, the treatment will cease on the day of discharge. The primary outcome will be the time to first defecation. The secondary outcome measures will include time to first flatus, tolerability of semiliquid and solid food, length of postoperative hospital stay, postoperative nausea and vomiting, abdominal distension, postoperative pain, postoperative analgesic, time to first ambulation, blinding assessment, credibility and expectancy and readmission rate.Ethics and disseminationEthics approval was obtained from the Ethics Committee of Beijing University of Chinese Medicine (number 2020BZHYLL0116) and the institutional review board of each hospital. The results will be disseminated through peer-reviewed publications. This study protocol (V.3.0, 6 March 2020) involves human participants and was approved by the ethics committees of Beijing University of Chinese Medicine (number 2020BZHYLL0116), Beijing Friendship Hospital Affiliated to Capital Medical University (number 2020-P2-069-01), Beijing Chao-Yang Hospital Affiliated to Capital Medical University (number 2020-3-11-2), National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (number 20/163-2359), and the Affiliated Hospital of Qingdao University (number QYFYKYLL711311920). The participants gave informed consent to participate in the study before taking part.Trial registration numberChiCTR2000038444.

Project description:BackgroundPercutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.MethodsPreoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days.ResultsDuring the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001).ConclusionsPercutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.Editor’s perspective

Project description:BackgroundCardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined.ObjectiveThe aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery.MethodsA double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ≥18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ≥4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board.ResultsRecruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic.ConclusionsThis research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain.International registered report identifier (irrid)DERR1-10.2196/30951.

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Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial.

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Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial.

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