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TAP vs. ESP Blocks for Post-Cesarean Analgesia

ConditionPostoperative Pain After Cesarean Section
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMaternity Hospital - State Budgetary Institution of the Rostov Region, Taganrog

About this 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.

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

1. Bilateral ESP block at the L1 level; 2. Bilateral TAP block; 3. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine

    Drug

    0.375% solution for ultrasound-guided nerve blocks.

  • Ultrasound-guided Nerve Block

    Procedure/Surgery

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

  • 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.

  • Trimeperidine (Rescue)

    Drug

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

  • Ultrasound-guided ESP Block

    Procedure/Surgery

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

  • Ultrasound-guided TAP Block

    Procedure/Surgery

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

  • Ropivacaine

    Drug

    0.375% solution for nerve blocks.

Treatment groups

162 Participants
are divided into 3 treatment groups
Group A: Experimental: ESP Block GroupExperimental treatment 4 interventions
Group B: Experimental: TAP Block GroupExperimental treatment 4 interventions
Group C: Active Comparator: Standard Analgesia GroupActive comparator 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

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

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.

Time frame
Within 24 hours postoperatively
3

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.

Time frame
Within 24 hours postoperatively
4

Consumption of rescue analgesia

Number of patients requiring rescue analgesia (trimeperidine 20 mg IM) due to NRS pain score \> 4.

Time frame
Within 24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Collaborator

Source ClinicalTrials.gov

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