Acupuncture, Hemorrhoidectomy, Hemorrhoid Pain
Conditions
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.
Interventions
PROCEDUREAcupuncture
Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.
Sponsors
School of Chinese Medicine, The University of Hong Kong
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal pain intensity | Post-operative day 1 | Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain') |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Serum C-reactive protein level | Post-operative day 0 and 1 | — |
| 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. |
| Functional recovery questionnaire | 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) | — |
Contacts
Primary ContactPak Chiu Wong
Outcome results
None listed