Cesarean Delivery, Regional Anesthesia Block
Conditions
Keywords
ESP block, TAP block, cesarean section
Brief summary
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
PROCEDURETAP block
TAP block will be performed with with ropivacaine 0.375% 20 mL per side (total 40 mL)
PROCEDUREESP block
ESP block will be performed with ropivacaine 0.375% 20 mL per side (total 40 mL)
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Outcome assessor and investigator will be blind of the procedure as each patient will be associated with an unique ID. Patients and patient care provider could not be blind given the nature of the procedure
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Rest at 6 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Rest at 12 hours | 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 |
| Pain at Rest at 24 hours | 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 |
| Pain at Movement at 6 hours | 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 |
| Pain at Movement at 12 hours | 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 |
| Pain at Movement at 24 hours | 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 |
| Milligram of Morphine equivalents in the first 24 postoperative hours | from the end of the surgery to 24 hours after the surgery | Milligram of Morphine equivalents administered in the first 24 hours |
| Time to rescue analgesic requirement | Form the end of the surgery to the first rescue analgesic requirement (up to o 24 hours after the surgery) | Time the patients will require the first rescue analgesic requirement measured in minutes |
| Time to breast feeding | 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 |
| Time to deambulate | 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 |
Countries
Italy
Contacts
CONTACTLorenzo Alfonsi, MD
Outcome results
None listed