University Hospital of Padua
Padova, 35127, Italy
Location status: Recruiting
NCT Number: NCT07292662
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Padova, 35127, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pre-pregnancy weight <55 kg
TAP block will be performed with 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)
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
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
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
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
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
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
Time frame: from the end of the surgery to 24 hours after the surgery
Milligram of Morphine equivalents administered in the first 24 hours
Time frame: 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 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
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
Contact information is provided by the study sponsor or research team.
University of Padova
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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