LI4 and SP6 Acupuncture for Pain After Cesarean Delivery

NCT07869589 | Not Yet Recruiting

• 1 other identifier: GETAT-CS-LI4SP6-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Postoperative Pain After Cesarean Delivery

Keywords

Cesarean Delivery; Postoperative Pain; Acupuncture; LI4; SP6; Sham Acupuncture; Pain Management; Early Mobilization

Outcome Measures

Primary Outcomes (1)

• Pain Intensity During First Postoperative Ambulation

  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.

  At the 6th postoperative hour

Secondary Outcomes (12)

• Cumulative Resting Pain Burden (VAS AUC)

  From the 3rd to the 24th postoperative hour

• Cumulative Movement-Evoked Pain Burden (VAS AUC)

  From the 3rd to the 24th postoperative hour

• Postoperative Pain Intensity at Rest

  At the 3rd, 4th, 6th, 12th, and 24th postoperative hours

• Postoperative Movement-Evoked Pain Intensity

  At the 3rd, 4th, 12th, and 24th postoperative hours

• Number of Steps During First Postoperative Ambulation

  At the 6th postoperative hour

Study Arms (2)

LI4 + SP6 Acupuncture

EXPERIMENTAL

Participants will receive a single session of bilateral acupuncture at LI4 (Hegu) and SP6 (Sanyinjiao) at the third postoperative hour after cesarean delivery. Sterile acupuncture needles will be inserted at the four acupuncture sites and manually stimulated to elicit de qi. The needles will remain in place for 15 minutes. Participants will receive the standardized postoperative analgesic regimen used in the study, with rescue analgesia available when clinically required.

Procedure: LI4 + SP6 Acupuncture

Sham Acupuncture

SHAM COMPARATOR

Participants will receive a single sham acupuncture session 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, without skin penetration. The number of application sites, treatment duration (15 minutes), participant positioning, and practitioner interaction will be standardized to match the real acupuncture group. Participants will receive the same standardized postoperative analgesic regimen and rescue analgesia protocol as the acupuncture group.

Procedure: Park Sham Acupuncture

Interventions

LI4 + SP6 Acupuncture PROCEDURE

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.

LI4 + SP6 Acupuncture

Park Sham Acupuncture PROCEDURE

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Hospital

Niğde, Niğde Province, 51240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Pınar Erdoğan, Assoc. Prof.

CONTACT

05233646954; drpinarerdogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to treatment allocation. Real and sham procedures will be performed using a standardized protocol, with non-penetrating Park sham needles used in the sham group. The practitioner administering the acupuncture or sham procedure cannot be blinded because of the nature of the intervention and will not participate in postoperative pain or functional outcome assessments. Participant blinding will be evaluated after completion of the 24-hour outcome assessments by asking participants whether they believe they received real acupuncture, sham acupuncture, or are unsure. The statistical analysis will be performed using coded treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified IPD and supporting information will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
• Access Criteria: De-identified IPD and supporting information may be made available to qualified researchers who submit a methodologically sound proposal. Requests should be directed to the corresponding author and will be reviewed by the study investigators. Data will be provided for approved research purposes, subject to applicable ethical, institutional, and data-protection requirements. A data use agreement may be required before access is granted.

Locations

TU (1)