TAP Block Versus ESP Block in Patients Undergoing Elective Cesarean Section: a Randomized Controlled Trial

University of Padova

Status: Not yet enrolling

Conditions: Regional Anesthesia Block; Cesarean Delivery

Treatments: Procedure: TAP block; Procedure: ESP block

Study type: Interventional

Funder types: Other

Identifiers

NCT07292662

6334/AO/25

Details and patient eligibility

About

This study is comparing two types of pain relief techniques-TAP block and ESP block-for women having an elective cesarean section. Both techniques involve injecting local anesthetic under ultrasound guidance to numb nerves and reduce pain after surgery. The TAP block mainly relieves pain in the abdominal wall, while the ESP block may reduce both abdominal wall and deeper, organ-related pain. The main goal is to see if there's a difference in pain at rest six hours after surgery. The study will also look at pain at later time points, the amount of opioid medication needed, how quickly women can walk, and when they start breastfeeding.

A total of 156 women will be randomly assigned to receive one of the two blocks after standard spinal anesthesia. Pain will be measured using a simple 0-10 scale at 6, 12, and 24 hours, both at rest and during movement. The study follows strict ethical rules, ensures patient privacy, and all results-whether positive or negative-will be shared to help improve pain management after cesarean delivery.

Full description

This study is a prospective, monocentric, randomized controlled trial designed to compare the analgesic efficacy of the transversus abdominis plane (TAP) block versus the erector spinae plane (ESP) block in women undergoing elective cesarean section. Cesarean delivery, one of the most commonly performed surgical procedures worldwide, is associated with both somatic and visceral postoperative pain. Optimizing pain control is critical not only for maternal comfort but also for reducing complications, facilitating early mobilization, and supporting breastfeeding and maternal-infant bonding. While the TAP block provides effective somatic analgesia of the abdominal wall with a rapid learning curve, it does not address visceral pain. Conversely, the ESP block offers multidermatomal coverage, potentially reducing both somatic and visceral components of postoperative pain and opioid consumption. The primary objective of the study is to evaluate postoperative pain at rest six hours after surgery, with secondary outcomes including pain at various time points, opioid consumption, time to first rescue analgesia, ambulation, and initiation of breastfeeding.

A total of 156 patients meeting inclusion criteria (age 18-45 years, elective cesarean, informed consent) will be randomized to receive either a bilateral TAP or ESP block following standardized spinal anesthesia. Pain scores will be assessed using an 11-point Numeric Rating Scale (NRS) at 6, 12, and 24 hours postoperatively, both at rest and with movement. Opioid use, time to ambulation, and breastfeeding initiation will also be recorded. The study is powered to detect a clinically significant difference in pain scores, and data analysis will include tests for normality, parametric and non-parametric comparisons, repeated-measures analysis, regression models, and survival analysis for time-to-event outcomes. The trial adheres to ethical standards, including informed consent and data privacy, and the results will be disseminated regardless of outcome, contributing to evidence-based practice in post-cesarean analgesia.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 45 years
• Elective cesarean section
• Ability to provide informed consent

Exclusion criteria

• Allergy to any of the drugs used in the study
• Heart disease with impaired cardiac function
• Stage III or higher kidney failure
• Coagulation disorders (platelets <100,000/μL or INR >1.5) or severe liver disease
• Degenerative central nervous system diseases or peripheral neuropathies
• Previous uterine surgery (e.g., myomectomy)
• Previous cesarean section

Pre-pregnancy weight <55 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

TAP block

Active Comparator group

Description:

Patients will undergo preoperative bilateral TAP block with ropivacaine 0.375% 20 mL per side (total 40 mL)

Treatment:

Procedure: TAP block

ESP block

Experimental group

Description:

Patients will undergo preoperative bilateral ESP block with ropivacaine 0.375% 20 mL per side (total 40 mL)

Treatment:

Procedure: ESP block