MedPath

Acupuncture for Post-hemorrhoidectomy Pain Control

Not Applicable
Not yet recruiting
Conditions
Hemorrhoidectomy
Hemorrhoid Pain
Acupuncture
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
Inclusion Criteria
  • Symptomatic grade III or IV hemorrhoids undergoing conventional hemorrhoidectomy
Exclusion Criteria
  1. Patients scheduled for stapled hemorrhoidopexy
  2. Concomitant surgery other than conventional hemorrhoidectomy
  3. Bleeding tendency, thrombocytopenia (platelet count < 100 x 10^9/L)
  4. Immunocompromised status or use of chemotherapy
  5. Active dermatitis
  6. Patients with pacemaker or automated implantable cardioverter-defibrillator
  7. Pregnant patients
  8. Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including cyclooxygenase-2 inhibitors
  9. History of chronic pain (duration for 3 months or more)
  10. Daily use of strong opioids (e.g. morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine)
  11. Alcohol or drug abuse
  12. Psychiatric illness
  13. Impaired renal function (preoperative serum creatinine level > 120µmol/L)
  14. Recent acupuncture treatment for other medical conditions

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Maximal pain intensityPost-operative day 1

Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain')

Secondary Outcome Measures
NameTimeMethod
Maximal and resting pain intensityPost-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 requirementPost-operative 2 weeks

Dosage of paracetamol, tramadol and celecoxib tablets taken per day over the first post-operative 2 weeks

Length of hospital stayPost-operative day 1
Functional recovery questionnaireQuestionnaire to measure time to first bowel motion, time to first urination and time to return to work, counted from the day of operation
Adverse effectPost-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 levelPost-operative day 0 and 1

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