LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNigde Omer Halisdemir University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LI4 + SP6 Acupuncture
Procedure/SurgeryA 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
Procedure/SurgeryA 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: LI4 + SP6 AcupunctureExperimental treatment 1 intervention
Group B: Sham AcupunctureSham comparator 1 intervention
Trial outcomes
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.
Time frame
At the 6th postoperative hourSecondary outcomes
1
Cumulative Resting Pain Burden (VAS AUC)
Cumulative resting pain burden will be calculated as the area under the curve (AUC) for 0-10 VAS pain scores obtained at rest at the 3rd (pre-intervention), 4th, 6th, 12th, and 24th postoperative hours. AUC will be calculated using the trapezoidal rule, with higher values indicating greater cumulative pain burden.
Time frame
From the 3rd to the 24th postoperative hour2
Cumulative Movement-Evoked Pain Burden (VAS AUC)
Cumulative movement-evoked pain burden will be calculated as the area under the curve (AUC) for 0-10 VAS pain scores obtained during standardized postoperative movement at the 3rd, 4th, 6th, 12th, and 24th postoperative hours. Movement will consist of standardized in-bed movement at the earlier assessments and mobilization/ambulation at later assessments. AUC will be calculated using the trapezoidal rule, with higher values indicating greater cumulative movement-evoked pain burden.
Time frame
From the 3rd to the 24th postoperative hour3
Postoperative Pain Intensity at Rest
Pain intensity at rest will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Assessments will be performed at the 3rd postoperative hour immediately before the study intervention and at the 4th, 6th, 12th, and 24th postoperative hours.
Time frame
At the 3rd, 4th, 6th, 12th, and 24th postoperative hours4
Postoperative Movement-Evoked Pain Intensity
Movement-evoked pain intensity will be assessed using a 0-10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. At the 3rd and 4th postoperative hours, pain will be assessed during standardized in-bed movement. At the 12th and 24th postoperative hours, pain will be assessed during standardized postoperative mobilization.
Time frame
At the 3rd, 4th, 12th, and 24th postoperative hoursSponsors and contacts
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Source ClinicalTrials.gov
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