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Starting soon Not applicable

LI4 and SP6 Acupuncture for Pain After Cesarean Delivery

NCT07869589 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-11-01
Last updated
2026-10-09

Condition(s) studied

Acute Postoperative Pain After Cesarean Delivery

Investigational drug(s) / intervention(s)

LI4 + SP6 AcupuncturePark Sham Acupuncture

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Women aged 18-50 years * Undergoing elective cesarean delivery under spinal anesthesia * Able to understand and use the 0-10 visual analog scale (VAS) * Able to provide written informed consent Exclusion Criteria: * Emergency cesarean delivery * Conversion from spinal to general anesthesia or requirement for general anesthesia * Known allergy or contraindication to medications included in the standardized postoperative analgesic protocol * Presence of infection, skin lesion, or other condition preventing acupuncture or sham application at the LI4 or SP6 sites * Known bleeding disorder or clinically significant coagulation abnormality * Neurological, musculoskeletal, or other medical condition that would prevent or substantially limit postoperative mobilization * Chronic pain requiring regular analgesic medication * Regular opioid use before surgery * Inability to reliably assess or report pain intensity * Any postoperative clinical condition requiring deviation from the planned analgesic or mobilization protocol

Primary outcome measure(s)

  • Pain Intensity During First Postoperative Ambulation — At the 6th postoperative hour
    Pain intensity during the first postoperative ambulation will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. First ambulation will be performed at the sixth postoperative hour and will include progression from sitting at the bedside to standing and walking. Participants will rate the pain experienced during the first ambulation, with higher scores indicating greater pain intensity.

Trial sites (1)

FacilityCityRegionStatus
Niğde Ömer Halisdemir University Hospital Niğde Niğde Province
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07869589 on ClinicalTrials.gov ↗ ← All trials in Turkey