TAP Block Versus ESP Block in Patients Undergoing Elective Cesarean Section: a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAP block, ESP block.
- Who it may be relevant to
- Registry conditions: Cesarean Delivery, Regional Anesthesia Block. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Procedure TAP block
TAP block will be performed with with ropivacaine 0.375% 20 mL per side (total 40 mL) - Procedure ESP block
ESP block will be performed with ropivacaine 0.375% 20 mL per side (total 40 mL)
Primary outcome measures
- Pain at Rest at 6 hours [Time frame: 6 hours after end of surgery]
Secondary outcome measures (9)
- Pain at Rest at 12 hours [Time frame: 12 hours after end of surgery]
- Pain at Rest at 24 hours [Time frame: 24 hours after end of surgery]
- Pain at Movement at 6 hours [Time frame: 6 hours after end of surgery]
- Pain at Movement at 12 hours [Time frame: 12 hours after end of surgery]
- Pain at Movement at 24 hours [Time frame: 24 hours after end of surgery]
- Milligram of Morphine equivalents in the first 24 postoperative hours [Time frame: from the end of the surgery to 24 hours after the surgery]
- Time to rescue analgesic requirement [Time frame: Form the end of the surgery to the first rescue analgesic requirement (up to o 24 hours after the surgery)]
- Time to breast feeding [Time frame: Form the end of the surgery to the start of breast feeding (up to o 24 hours after the surgery)]
- Time to deambulate [Time frame: Form the end of the surgery to the start of deambulation (up to o 24 hours after the surgery)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- University Hospital of Padua — Padova
Identifiers
NCT: NCT07292662 · 6334/AO/25