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NCT07869589
LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
Conditions: Acute Postoperative Pain After Cesarean Delivery
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Nigde Omer Halisdemir University
Location: Niğde Ömer Halisdemir University Hospital Niğde Niğde Province
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 Criteria
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
Source: ClinicalTrials.gov (NCT07869589). StuddyBuddy aggregates publicly available trial information.