Postoperative Pain After Cesarean SectionRCT-TAP-ESP-CSNCT07853482
TAP vs. ESP Blocks for Post-Cesarean Analgesia
A study testing Ropivacaine, Ultrasound-guided Nerve Block and Ketoprofen and Paracetamol in people with Postoperative Pain After Cesarean Section, run by Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog at 1 site in Russia.
Trial summary
This study compares the effectiveness of two ultrasound-guided nerve blocks (TAP block and ESP block) versus standard pain management for relieving pain after a planned cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Pain After Cesarean Section
- What is being tested?
- Ropivacaine, Ultrasound-guided Nerve Block and Ketoprofen and Paracetamol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteRussia
- Study dates
- 15 Oct 2026to 10 Jun 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 40 years.
- ASA physical status I-II.
- Scheduled for elective cesarean delivery under spinal anesthesia at term (37-41 weeks of gestation).
- Single fetus pregnancy.
- Provided written informed consent to participate in the study.
Who cannot join
- Emergency cesarean delivery.
- Contraindications to regional anesthesia (e.g., coagulation disorders, infection at the injection site, patient refusal).
- Known allergy to local anesthetics (ropivacaine, bupivacaine) or NSAIDs (ketoprofen).
- Chronic pain syndrome or regular use of opioid analgesics prior to surgery.
- BMI > 35 kg/m².
- Multiple pregnancy (twins, triplets, etc.).
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- Pre-eclampsia or eclampsia.
- Inability to communicate or understand the pain assessment scales (NRS).
- Previous abdominal surgery with extensive adhesions that may alter anatomy for nerve blocks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog
Taganrog, Rostov Oblast, 347900
Aleksandr A. Bezverkhiy, PhD, +79034300922, aab@arekusand.ru
Aleksandr A. Bezverkhiy, PhD
About this study
Official title: Comparative Efficacy of Transversus Abdominis Plane (TAP) and Erector Spinae Plane (ESP) Blocks for Postoperative Analgesia After Elective Cesarean Section: A Prospective, Single-Center, Randomized Controlled Trial
This study compares the effectiveness of two ultrasound-guided nerve blocks (TAP block and ESP block) versus standard pain management for relieving pain after a planned cesarean section.
Cesarean delivery often causes moderate to severe pain, which can be divided into somatic pain (from the abdominal incision) and visceral pain (from uterine contractions and internal tissues). While transversus abdominis plane (TAP) blocks are commonly used, erector spinae plane (ESP) blocks are a newer technique that may provide better relief for visceral pain.
Read more
In this randomized controlled trial, 162 women undergoing elective cesarean delivery under spinal anesthesia will be assigned to one of three groups:
- Bilateral ESP block at the L1 level;
- Bilateral TAP block;
- Standard analgesia without nerve blocks.
The primary goal is to determine which method provides better control of visceral pain in the first 16 hours after surgery. Secondary goals include assessing somatic pain, time to first mobilization, time to first skin-to-skin contact with the baby, and the need for additional rescue pain medication. The study aims to support early recovery and improve mother-infant bonding by optimizing postoperative pain control.
Read the detailed description
Background:
Postoperative pain after cesarean delivery has a dual nature: a somatic component resulting from the abdominal wall incision and a visceral component arising from uterine contraction and tissue trauma (innervated by Th10-L1 segments). According to PROSPECT (2021) guidelines, multimodal analgesia is the standard of care. Interfascial plane blocks, such as the Transversus Abdominis Plane (TAP) block and the Erector Spinae Plane (ESP) block, have shown efficacy in controlling somatic pain. However, data comparing their differential efficacy on visceral versus somatic pain components are limited. The ESP block, performed at the L1 level, theoretically offers superior visceral analgesia due to the spread of local anesthetic to the dorsal rami of spinal nerves and potential craniocaudal spread into the paravertebral/epidural space.
Study Design:
This is a prospective, single-center, randomized, single-blind controlled trial conducted at the Maternity Hospital in Taganrog, Rostov Oblast, Russia. A total of 162 patients undergoing elective cesarean delivery under spinal anesthesia will be enrolled. Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups:
- ESP Block Group: Patients will receive a bilateral ultrasound-guided ESP block at the L1 level in the post-anesthesia care unit. 20 mL of 0.375% ropivacaine will be injected on each side (total 40 mL).
- TAP Block Group: Patients will receive a bilateral ultrasound-guided TAP block in the post-anesthesia care unit. 20 mL of 0.375% ropivacaine will be injected on each side (total 40 mL).
- Control Group: Patients will receive standard postoperative analgesia without interfascial blocks. This includes ketoprofen 100 mg IM at 4 hours, and oral paracetamol + ketoprofen at 12 hours. Rescue analgesia (trimeperidine 20 mg IM) will be provided if the pain score exceeds 4 on the Numerical Rating Scale (NRS).
All patients will undergo spinal anesthesia with hyperbaric bupivacaine 0.5% (2.2 mL) at the L2-L3 interspace. Preoperatively, pain threshold will be assessed using Nevidimova's method.
Outcome Measures:
The primary outcome is the intensity of visceral pain measured by the Numerical Rating Scale (NRS, 0-10) at 2, 4, 8, 12, and 16 hours postoperatively. Visceral pain is defined as dull, cramping lower abdominal pain.
Secondary outcomes include:
- Intensity of somatic pain (NRS 0-10) at the same time points.
- Time to independent mobilization (hours).
- Time to first mother-infant skin-to-skin contact (hours).
- Consumption of rescue analgesia (number of trimeperidine injections).
- Incidence of adverse events (hypotension, nausea, vomiting, pruritus, signs of local anesthetic systemic toxicity).
Statistical Analysis:
Based on a power analysis (80% power, α=0.05), a minimum of 54 patients per group (162 total) is required to detect a clinically significant difference of 1.5 points in visceral pain scores. Data will be analyzed using the Kruskal-Wallis test for between-group comparisons and the Friedman test for within-group dynamics. A p-value < 0.05 will be considered statistically significant.
Ethical Considerations:
The study is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All participants will provide written informed consent. Personal data will be coded and stored securely. The study has been approved by the Local Ethics Committee of I.M. Sechenov First Moscow State Medical University.
- Being tested
- Ropivacaine, Ultrasound-guided Nerve Block, Ketoprofen and Paracetamol, Trimeperidine (Rescue), Ultrasound-guided ESP Block
- Keywords
- Cesarean section, postoperative pain, TAP block, ESP block, erector spinae plane block, transversus abdominis plane block, regional anesthesia, visceral pain, somatic pain, ropivacaine
- Medical subject headings
- Pain, Postoperative, Visceral Pain, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
0.375% solution for ultrasound-guided nerve blocks.
Ultrasound-guided Nerve BlockProcedure or surgery
Bilateral TAP or ESP block performed in the post-anesthesia care unit.
Ketoprofen and ParacetamolDrug
Baseline multimodal analgesia administered to ALL groups: Ketoprofen 100 mg IM at 4 hours postoperatively, followed by oral paracetamol + ketoprofen at 12 hours.
Trimeperidine (Rescue)Drug
Rescue analgesia (Trimeperidine 20 mg IM) administered ONLY in the Control Group if NRS pain score > 4.
Ultrasound-guided ESP BlockProcedure or surgery
Bilateral ESP block at L1 level with 20 mL of 0.375% ropivacaine per side.
Ultrasound-guided TAP BlockProcedure or surgery
Bilateral TAP block with 20 mL of 0.375% ropivacaine per side.
RopivacaineDrug
0.375% solution for nerve blocks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: ESP Block Group | Experimental | Participants receive baseline multimodal analgesia (ketoprofen + paracetamol) PLUS bilateral ultrasound-guided ESP block at L1 level (20 mL of 0.375% ropivacaine per side). No trimeperidine is administered in this group. Receives: Drug: Ropivacaine; Procedure: Ultrasound-guided Nerve Block; Drug: Ketoprofen and Paracetamol; Procedure: Ultrasound-guided ESP Block |
| Experimental: TAP Block Group | Experimental | Participants receive baseline multimodal analgesia (ketoprofen + paracetamol) PLUS bilateral ultrasound-guided TAP block (20 mL of 0.375% ropivacaine per side). No trimeperidine is administered in this group. Receives: Drug: Ropivacaine; Procedure: Ultrasound-guided Nerve Block; Drug: Ketoprofen and Paracetamol; Procedure: Ultrasound-guided TAP Block |
| Active Comparator: Standard Analgesia Group | Active comparator | Participants receive baseline multimodal analgesia (ketoprofen + paracetamol) WITHOUT interfascial blocks. Rescue analgesia with trimeperidine 20 mg IM is available if NRS > 4. Receives: Drug: Ketoprofen and Paracetamol; Drug: Trimeperidine (Rescue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of visceral pain at 16 hours postoperatively
Visceral pain intensity will be assessed using the Numerical Rating Scale (NRS, 0-10) at 2, 4, 8, 12, and 16 hours after surgery. The primary endpoint is the NRS score at 16 hours. Visceral pain is defined as dull, cramping lower abdominal pain.
Measured: 2, 4, 8, 12, and 16 hours postoperatively
Secondary outcomes (5)
Intensity of somatic pain at 16 hours postoperatively
Somatic pain intensity (incisional pain) will be assessed using the Numerical Rating Scale (NRS, 0-10) at the same time points as visceral pain.
Measured: 2, 4, 8, 12, and 16 hours postoperatively
Time to first independent mobilization
Time (in hours) from the end of surgery to the patient's first attempt to sit up or stand without assistance.
Measured: Within 24 hours postoperatively
Time to first mother-infant skin-to-skin contact
Time (in hours) from the end of surgery to the first sustained skin-to-skin contact between the mother and the newborn.
Measured: Within 24 hours postoperatively
Consumption of rescue analgesia
Number of patients requiring rescue analgesia (trimeperidine 20 mg IM) due to NRS pain score > 4.
Measured: Within 24 hours postoperatively
Incidence of adverse events
Frequency of hypotension, nausea, vomiting, pruritus, and signs of local anesthetic systemic toxicity (LAST).
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain After Cesarean SectionStudies 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
- Model description
- Three parallel groups with a 1:1:1 allocation ratio. Group 1 receives bilateral ESP block, Group 2 receives bilateral TAP block, and Group 3 receives standard analgesia without blocks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog
- Sponsor type
- Other government
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Responsible party
- Principal investigator, Alexander Bezverkhiy, Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog
- Investigators
- Aleksandr A. Bezverkhiy, PhD, Principal investigator, Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853482
- Sponsor's protocol ID
- RCT-TAP-ESP-CS-2026
- Other IDs
- RCT-TAP-ESP-CS-2026
- Acronym
- RCT-TAP-ESP-CS
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to strict national regulations on the protection of personal health information in the Russian Federation and to ensure the complete confidentiality and privacy of study participants. Data will be available only to the principal investigator and the local ethics committee for verification purposes.