An interventional study of Bilateral Acupuncture Protocol and Park Sham Acupuncture in Acute Postoperative Pain After Cesarean Delivery, sponsored by Nigde Omer Halisdemir University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Nigde Omer Halisdemir University · Not applicable, Interventional, and Treatment
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.
Acute postoperative pain is common after cesarean delivery and may interfere with early mobilization, maternal recovery, newborn care, and breastfeeding. Acupuncture has been investigated as a non-pharmacological adjunct to postoperative analgesia; however, evidence regarding the effectiveness of specific acupuncture protocols for acute post-cesarean pain remains limited.
This single-center, parallel-group, sham-controlled randomized clinical trial will investigate the analgesic effectiveness of a single postoperative session of bilateral LI4 (Hegu) and SP6 (Sanyinjiao) acupuncture in women undergoing cesarean delivery under spinal anesthesia. Eligible participants will be randomly allocated in a 1:1 ratio to either real acupuncture or sham acupuncture using non-penetrating Park sham needles. The intervention will be administered at the third postoperative hour.
Postoperative analgesia will be standardized in both groups. Participants will receive paracetamol 1 g intravenously after delivery and umbilical cord clamping, followed by paracetamol 1 g every 8 hours, administered orally once oral intake is tolerated. Diclofenac 75 mg will be available as first-line rescue analgesia for clinically significant pain (VAS ≥4) or upon participant request. If pain remains inadequately controlled despite first-line rescue analgesia, morphine 2 mg intravenously will be available as second-line rescue analgesia. Clinically indicated analgesia will not be withheld or delayed for study purposes. The timing and dose of all rescue analgesics will be recorded.
Pain intensity will be assessed using a 0-10 VAS at predefined postoperative time points. Assessments will distinguish pain at rest from movement-evoked pain. At the third postoperative hour, immediately before the study intervention, pain will be assessed at rest and during standardized movement in bed. These assessments will be repeated at the fourth postoperative hour. At the sixth postoperative hour, participants will undergo their first postoperative ambulation. Pain intensity during first ambulation at the sixth postoperative hour will constitute the primary outcome. Pain at rest and during movement will also be evaluated at subsequent postoperative assessments through 24 hours.
Functional performance during first mobilization will be evaluated by recording the number of steps taken during the first ambulation. Secondary analgesic outcomes will include rescue diclofenac use and total dose, time to first rescue analgesia, and the requirement for and total dose of second-line opioid rescue analgesia. Acupuncture-related adverse events will also be recorded.
After completion of the 24-hour clinical outcome assessments, participants will be asked whether they believe they received real acupuncture, sham acupuncture, or are unsure, to assess the effectiveness of participant blinding.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 140 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Nigde Omer Halisdemir University is the lead sponsor of 92 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
A single standardized acupuncture procedure will be administered at the third postoperative hour after cesarean delivery. The procedure consists of needle insertion at bilateral LI4 (Hegu) and SP6 (Sanyinjiao) acupuncture points, for a total of four sites. Sterile acupuncture needles (0.25 × 25 mm) 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: Bilateral Acupuncture Protocol
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
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.
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.
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 hour
Cumulative Resting Pain Burden (VAS AUC)
Resting pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at postoperative hours 3 (pre-intervention), 4, 6, 12, and 24. The area under the curve (AUC) will be calculated using the trapezoidal rule over the 21-hour interval. The theoretical AUC range is 0-210 VAS-point-hours. Higher AUC values indicate greater cumulative resting pain burden and therefore a worse outcome.
Time frame: From the 3rd to the 24th postoperative hour
Cumulative Movement-Evoked Pain Burden (VAS AUC)
Movement-evoked pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), at postoperative hours 3 (pre-intervention), 4, 6, 12, and 24. Pain will be assessed during standardized movement or mobilization activities. The area under the curve (AUC) will be calculated using the trapezoidal rule over the 21-hour interval. The theoretical AUC range is 0-210 VAS-point-hours. Higher AUC values indicate greater cumulative movement-evoked pain burden and therefore a worse outcome.
Time frame: From the 3rd to the 24th postoperative hour
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 hours
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 hours
Number of Steps During First Postoperative Ambulation
Functional performance during first postoperative ambulation will be assessed by recording the total number of steps taken during the first ambulation performed at the 6th postoperative hour.
Time frame: At the 6th postoperative hour
Total Rescue Diclofenac Consumption
The cumulative dose of diclofenac administered as first-line rescue analgesia during the first 24 postoperative hours will be recorded in milligrams. Diclofenac 75 mg will be available for clinically significant pain (VAS ≥4) or upon participant request. Higher cumulative doses indicate greater rescue analgesic requirement.
Time frame: During the first 24 postoperative hours
Requirement for First-Line Rescue Analgesia
The proportion of participants requiring at least one dose of diclofenac as first-line rescue analgesia during the first 24 postoperative hours will be recorded.
Time frame: During the first 24 postoperative hours
Time to First Rescue Analgesia
Time from administration of the acupuncture or sham intervention at the 3rd postoperative hour to the first administration of rescue analgesia will be recorded in hours. Participants who do not require rescue analgesia during the observation period will be treated as censored at the end of the 24-hour postoperative follow-up.
Time frame: From the study intervention at the 3rd postoperative hour through the 24th postoperative hour
Requirement for Second-Line Opioid Rescue Analgesia
The number and proportion of participants requiring intravenous morphine as second-line rescue analgesia because of inadequate pain control despite first-line rescue analgesia will be recorded.
Time frame: During the first 24 postoperative hours
Total Rescue Morphine Consumption
The cumulative dose of intravenous morphine administered as second-line rescue analgesia during the first 24 postoperative hours will be recorded in milligrams.
Time frame: During the first 24 postoperative hours
Acupuncture-Related Adverse Events
Acupuncture- or sham-procedure-related adverse events, including local pain, minor bleeding, hematoma, dizziness, and vasovagal reactions, will be recorded. The number and proportion of participants experiencing at least one intervention-related adverse event will be reported.
Time frame: From the study intervention through the 24th postoperative hour
Participant Blinding Assessment
After completion of all 24-hour clinical outcome assessments, participants will be asked to identify their perceived treatment allocation using three response categories: real acupuncture, sham acupuncture, or unsure. Responses will be compared with actual treatment allocation to evaluate participant blinding. This is a categorical assessment, not a numerical scale; therefore, no minimum or maximum score applies. The number and proportion of participants selecting each response category will be reported by treatment group.
Time frame: At the 24th postoperative hour, after completion of all clinical outcome assessments
Plan to share: Yes — De-identified individual participant data underlying the results reported in the published article may be shared with qualified researchers upon reasonable request to the corresponding author, subject to review and approval of the proposed use and applicable ethical and institutional requirements.
Supporting information: Study protocol, Statistical analysis plan
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.
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Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 8 months is below that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nigde Omer Halisdemir University