Acupuncture for Post-hemorrhoidectomy Pain Control

N/ANot Yet RecruitingNCT07238504

The University of Hong Kong100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Hemorrhoidectomy Hemorrhoid Pain Acupuncture

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Maximal pain intensity

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

Time frame: Post-operative day 1

Secondary Outcomes

Maximal and resting pain intensity

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

Time frame: Post-operative day 0, 2 to 7 and 14

Dosage of analgesics requirement

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

Time frame: Post-operative 2 weeks

Length of hospital stay

Time frame: Post-operative day 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)

Adverse effect

Effect from analgesics and acupuncture

Time frame: Post-operative 2 weeks

Quality of recovery (QoR)

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.

Time frame: Post-operative day 1

Serum C-reactive protein level

Time frame: Post-operative day 0 and 1

Acupuncture for Post-hemorrhoidectomy Pain Control

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts