- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07238504
Acupuncture for Post-hemorrhoidectomy Pain Control
Acupuncture for Post-hemorrhoidectomy Pain Control With Acute Anti-inflammatory Effects: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pak Chiu Wong
- Phone Number: +852-70836168
- Email: pwongpc@connect.hku.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Symptomatic grade III or IV hemorrhoids undergoing conventional hemorrhoidectomy
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fully active acupuncture
|
Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.
Other Names:
Minimal electrical stimulation to 1 local acupoint and 2 distant acupoints
Other Names:
|
|
Sham Comparator: Minimum acupuncture stimulation
|
Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.
Other Names:
Minimal electrical stimulation to 1 local acupoint and 2 distant acupoints
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal pain intensity
Time Frame: Post-operative day 1
|
Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain')
|
Post-operative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal and resting pain intensity
Time Frame: Post-operative day 0, 2 to 7 and 14
|
Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 mean 'worst pain')
|
Post-operative day 0, 2 to 7 and 14
|
|
Dosage of analgesics requirement
Time Frame: Post-operative 2 weeks
|
Dosage of paracetamol, tramadol and celecoxib tablets taken per day over the first post-operative 2 weeks
|
Post-operative 2 weeks
|
|
Length of hospital stay
Time Frame: Post-operative day 1
|
Post-operative day 1
|
|
|
Adverse effect
Time Frame: Post-operative 2 weeks
|
Effect from analgesics and acupuncture
|
Post-operative 2 weeks
|
|
Quality of recovery (QoR)
Time Frame: 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.
|
Post-operative day 1
|
|
Serum C-reactive protein level
Time Frame: Post-operative day 0 and 1
|
Post-operative day 0 and 1
|
|
|
Functional recovery questionnaire
Time Frame: Post-operative 1 week (time to first bowel motion, time to first urination and time to return to work, counted from the day of operation)
|
Post-operative 1 week (time to first bowel motion, time to first urination and time to return to work, counted from the day of operation)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 25-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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