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NOT YET RECRUITING
NCT07869589
NA

LI4 and SP6 Acupuncture for Pain After Cesarean Delivery

Sponsor: Nigde Omer Halisdemir University

View on ClinicalTrials.gov

Summary

This randomized, sham-controlled clinical trial will evaluate the effectiveness of acupuncture at bilateral LI4 and SP6 as an adjunct to standard postoperative analgesia for acute pain after cesarean delivery. Women undergoing cesarean delivery under spinal anesthesia will be randomly assigned to receive either real acupuncture at bilateral LI4 and SP6 or sham acupuncture using non-penetrating Park sham needles. The acupuncture or sham intervention will be administered at the third postoperative hour. All participants will receive a standardized postoperative analgesic regimen, with additional rescue analgesia available when clinically required. The primary outcome will be pain intensity during first postoperative ambulation at the sixth postoperative hour, measured using a 0-10 visual analog scale (VAS). Secondary outcomes will include pain at rest and during movement at predefined postoperative time points, functional performance during first mobilization, rescue analgesic requirements, and acupuncture-related adverse events. Participant blinding will also be assessed after completion of the 24-hour outcome assessments.

Official title: Effectiveness of LI4 and SP6 Acupuncture for Acute Postoperative Pain After Cesarean Delivery: A Sham-Controlled Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-11-01

Completion Date

2027-07-01

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

PROCEDURE

LI4 + SP6 Acupuncture

A single acupuncture session will be administered at the third postoperative hour after cesarean delivery. Sterile acupuncture needles (0.25 × 25 mm) will be inserted bilaterally at LI4 (Hegu) and SP6 (Sanyinjiao), for a total of four acupuncture sites. Needles will be inserted to an approximate depth of 1.5-2 cm and manually stimulated to elicit de qi. The needles will remain in place for 15 minutes.

PROCEDURE

Park Sham Acupuncture

A single sham acupuncture session will be administered at the third postoperative hour after cesarean delivery. Non-penetrating Park sham needles will be applied bilaterally at the same LI4 (Hegu) and SP6 (Sanyinjiao) locations used in the real acupuncture group, for a total of four application sites. The sham needles will not penetrate the skin. Treatment duration, participant positioning, and practitioner interaction will be standardized to match the real acupuncture procedure. The sham needles will remain in place for 15 minutes.

Locations (1)

Niğde Ömer Halisdemir University Hospital

Niğde, Niğde Province, Turkey (Türkiye)