Acupuncture for Post-hemorrhoidectomy Pain Control
- Conditions
- HemorrhoidectomyHemorrhoid PainAcupuncture
- Registration Number
- NCT07238504
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
The goal of this clinical trial is to learn if acupuncture improves pain control after hemorrhoidectomy in patients with symptomatic hemorrhoids. It will also learn about the safety of using acupuncture in surgical patients. The main questions it aims to answer are:
Does acupuncture lower the maximal pain intensity after hemorrhoidectomy? Does acupuncture reduce analgesics requirement, length of hospital stay and quality of recovery?
Researchers will compare fully active acupuncture to a sham treatment (a look-alike procedure with minimum acupuncture stimulation) to see if active acupuncture works to improve pain control.
Participants will:
Receive acupuncture treatment for 7 times over first 5 days after surgery. Visit the clinic once 2 weeks after surgery for checkups and tests. Keep a diary of their symptoms and the number of times they take pain-killers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Symptomatic grade III or IV hemorrhoids undergoing conventional hemorrhoidectomy
- Patients scheduled for stapled hemorrhoidopexy
- Concomitant surgery other than conventional hemorrhoidectomy
- Bleeding tendency, thrombocytopenia (platelet count < 100 x 10^9/L)
- Immunocompromised status or use of chemotherapy
- Active dermatitis
- Patients with pacemaker or automated implantable cardioverter-defibrillator
- Pregnant patients
- Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including cyclooxygenase-2 inhibitors
- History of chronic pain (duration for 3 months or more)
- Daily use of strong opioids (e.g. morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine)
- Alcohol or drug abuse
- Psychiatric illness
- Impaired renal function (preoperative serum creatinine level > 120µmol/L)
- Recent acupuncture treatment for other medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maximal pain intensity Post-operative day 1 Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain')
- Secondary Outcome Measures
Name Time Method Maximal and resting pain intensity Post-operative day 0, 2 to 7 and 14 Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 mean 'worst pain')
Dosage of analgesics requirement Post-operative 2 weeks Dosage of paracetamol, tramadol and celecoxib tablets taken per day over the first post-operative 2 weeks
Length of hospital stay Post-operative day 1 Functional recovery questionnaire Questionnaire to measure time to first bowel motion, time to first urination and time to return to work, counted from the day of operation Adverse effect Post-operative 2 weeks Effect from analgesics and acupuncture
Quality of recovery (QoR) Post-operative day 1 QoR-15 questionnaire, which includes 15 questions scoring at a 10-point scale. Minimum at 0 means worst outcome and maximum at 10 means best outcome.
Serum C-reactive protein level Post-operative day 0 and 1
