- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292662
TAP Block Versus ESP Block in Patients Undergoing Elective Cesarean Section: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lorenzo Alfonsi, MD
- Phone Number: +390498213090
- Email: lorenzo.alfonsi@aopd.veneto.it
Study Locations
-
-
-
Padova, Italy, 35127
- Recruiting
- University Hospital of Padua
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TAP block
Patients will undergo preoperative bilateral TAP block with ropivacaine 0.375% 20 mL per side (total 40 mL)
|
TAP block will be performed with with ropivacaine 0.375% 20 mL per side (total 40 mL)
|
|
Experimental: ESP block
Patients will undergo preoperative bilateral ESP block with ropivacaine 0.375% 20 mL per side (total 40 mL)
|
ESP block will be performed with ropivacaine 0.375% 20 mL per side (total 40 mL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain at Rest at 6 hours
Time Frame: 6 hours after end of surgery
|
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
|
6 hours after end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain at Rest at 12 hours
Time Frame: 12 hours after end of surgery
|
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
|
12 hours after end of surgery
|
|
Pain at Rest at 24 hours
Time Frame: 24 hours after end of surgery
|
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
|
24 hours after end of surgery
|
|
Pain at Movement at 6 hours
Time Frame: 6 hours after end of surgery
|
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
|
6 hours after end of surgery
|
|
Pain at Movement at 12 hours
Time Frame: 12 hours after end of surgery
|
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
|
12 hours after end of surgery
|
|
Pain at Movement at 24 hours
Time Frame: 24 hours after end of surgery
|
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
|
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
|
Milligram of Morphine equivalents administered in the first 24 hours
|
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)
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Time the patients will require the first rescue analgesic requirement measured in minutes
|
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 the patients will breast feed expressed in minutes
|
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)
|
Time the patients will deambulate expressed in minutes
|
Form the end of the surgery to the start of deambulation (up to o 24 hours after the surgery)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6334/AO/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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