TAP vs. ESP Blocks for Post-Cesarean Analgesia: A Randomized Controlled Trial

NCT07853482 | Not Yet Recruiting

• 1 other identifier: RCT-TAP-ESP-CS-2026
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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. 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. In this randomized controlled trial, 162 women undergoing elective cesarean delivery under spinal anesthesia will be assigned to one of three groups:

1. 1.Bilateral ESP block at the L1 level;
2. 2.Bilateral TAP block;
3. 3.Standard analgesia without nerve blocks.

Conditions

Postoperative Pain After Cesarean Section

Keywords

Cesarean section; postoperative pain; TAP block; ESP block; erector spinae plane block; transversus abdominis plane block; regional anesthesia; visceral pain; somatic pain; ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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.

  2, 4, 8, 12, and 16 hours postoperatively

Secondary Outcomes (5)

• Intensity of somatic pain at 16 hours postoperatively

  2, 4, 8, 12, and 16 hours postoperatively

• Time to first independent mobilization

  Within 24 hours postoperatively

• Time to first mother-infant skin-to-skin contact

  Within 24 hours postoperatively

• Consumption of rescue analgesia

  Within 24 hours postoperatively

• Incidence of adverse events

  Within 24 hours postoperatively

Study Arms (3)

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.

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.

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.

Drug: Ketoprofen and Paracetamol; Drug: Trimeperidine (Rescue)

Interventions

Ropivacaine DRUG

0.375% solution for ultrasound-guided nerve blocks.

Experimental: ESP Block Group; Experimental: TAP Block Group

Ultrasound-guided Nerve Block PROCEDURE

Bilateral TAP or ESP block performed in the post-anesthesia care unit.

Experimental: ESP Block Group; Experimental: TAP Block Group

Ketoprofen and Paracetamol DRUG

Baseline multimodal analgesia administered to ALL groups: Ketoprofen 100 mg IM at 4 hours postoperatively, followed by oral paracetamol + ketoprofen at 12 hours.

Active Comparator: Standard Analgesia Group; Experimental: ESP Block Group; Experimental: TAP Block Group

Trimeperidine (Rescue) DRUG

Rescue analgesia (Trimeperidine 20 mg IM) administered ONLY in the Control Group if NRS pain score \> 4.

Active Comparator: Standard Analgesia Group

Ultrasound-guided ESP Block PROCEDURE

Bilateral ESP block at L1 level with 20 mL of 0.375% ropivacaine per side.

Experimental: ESP Block Group

Ultrasound-guided TAP Block PROCEDURE

Bilateral TAP block with 20 mL of 0.375% ropivacaine per side.

Experimental: TAP Block Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• 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.

Sponsors & Collaborators

• Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

Study Sites (1)

Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog

Taganrog, Rostov Oblast, 347900, Russia

Location

MeSH Terms

Conditions

Pain, Postoperative; Visceral Pain; Nociceptive Pain

Interventions

Ropivacaine; Ketoprofen; Acetaminophen; Promedol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Acetanilides; Meperidine; Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Aleksandr A. Bezverkhiy, PhD

  Maternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandr A. Bezverkhiy, PhD

CONTACT

+79034300922; aab@arekusand.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. Patients and outcome assessors are blinded to group allocation. The anesthesiologist performing the block is unblinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Anaesthesiology and Intensive Care; Associate Professor, Southern Federal University (Advanced Engineering School); PhD in Engineering

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): June 10, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)