Acupuncture for Post-hemorrhoidectomy Pain Control

NCT ID: NCT07238504

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2027-04-30

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.

Conditions

Hemorrhoidectomy; Hemorrhoid Pain; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fully active acupuncture

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.

Minimum acupuncture stimulation

Group Type: SHAM_COMPARATOR

Acupuncture

Intervention Type: PROCEDURE

Minimal electrical stimulation to 1 local acupoint and 2 distant acupoints

Interventions

Acupuncture

Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.

Intervention Type: PROCEDURE

Acupuncture

Minimal electrical stimulation to 1 local acupoint and 2 distant acupoints

Intervention Type: PROCEDURE

Other Intervention Names

Fully active acupuncture; Minimum acupuncture stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

School of Chinese Medicine, The University of Hong Kong

UNKNOWN

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Pak Chiu WONG

Associate Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Pak Chiu Wong

Role: CONTACT

pwongpc@connect.hku.hk

+852-70836168

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UW 25-302

Identifier Type: -

Identifier Source: org_study_id