Acute Postoperative Pain After Cesarean DeliveryNCT07869589
LI4 and SP6 Acupuncture for Pain After Cesarean Delivery
A study testing Bilateral Acupuncture Protocol in people with Acute Postoperative Pain After Cesarean Delivery, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Acute Postoperative Pain After Cesarean Delivery
- What is being tested?
- Bilateral Acupuncture Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University Hospital
Niğde, Niğde Province, 51240
Pınar Erdoğan, pinar.erdogan@ohu.edu.tr
About this study
Official title: Effectiveness of LI4 and SP6 Acupuncture for Acute Postoperative Pain After Cesarean Delivery: A Sham-Controlled Randomized Clinical 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.
Read the detailed description
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.
- Being tested
- Bilateral Acupuncture Protocol, Park Sham Acupuncture
- Keywords
- Cesarean Delivery, Postoperative Pain, Acupuncture, LI4, SP6, Sham Acupuncture, Pain Management, Early Mobilization
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Acupuncture ProtocolProcedure or surgery
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 AcupunctureProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Bilateral Acupuncture Protocol | Experimental | 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. Receives: Procedure: Bilateral Acupuncture Protocol |
| 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. Receives: Procedure: Park Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the 6th postoperative hour
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the 24th postoperative hour, after completion of all clinical outcome assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative Pain After Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Erdoğan, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869589
- Sponsor's protocol ID
- GETAT-CS-LI4SP6-01
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.