Cesarean DeliveryNCT07292662
TAP Block Versus ESP Block in Patients Undergoing Elective Cesarean Section: a Randomized Controlled Trial
A study testing TAP block and ESP block in people with Cesarean Delivery and Regional Anesthesia Block, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Delivery, Regional Anesthesia Block
- What is being tested?
- TAP block and ESP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2026to 9 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 45 years
- Elective cesarean section
- Ability to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cesarean Delivery, Regional Anesthesia Block
- Being tested
- TAP block, ESP block
- Keywords
- ESP block, TAP block, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
TAP block will be performed with with ropivacaine 0.375% 20 mL per side (total 40 mL)
ESP blockProcedure or surgery
ESP block will be performed with ropivacaine 0.375% 20 mL per side (total 40 mL)
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Active comparator | Patients will undergo preoperative bilateral TAP block with ropivacaine 0.375% 20 mL per side (total 40 mL) Receives: Procedure: TAP block |
| ESP block | Experimental | Patients will undergo preoperative bilateral ESP block with ropivacaine 0.375% 20 mL per side (total 40 mL) Receives: Procedure: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at Rest at 6 hours
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
Measured: 6 hours after end of surgery
Secondary outcomes (9)
Pain at Rest at 12 hours
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
Measured: 12 hours after end of surgery
Pain at Rest at 24 hours
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
Measured: 24 hours after end of surgery
Pain at Movement at 6 hours
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
Measured: 6 hours after end of surgery
Pain at Movement at 12 hours
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
Measured: 12 hours after end of surgery
Pain at Movement at 24 hours
Pain measured at Rest with Numeric Rating Scale (minimun 0- maximum 10) with 0 meaning no pain and 10 high pain
Measured: 24 hours after end of surgery
Milligram of Morphine equivalents in the first 24 postoperative hours
Milligram of Morphine equivalents administered in the first 24 hours
Measured: from the end of the surgery to 24 hours after the surgery
Time to rescue analgesic requirement
Time the patients will require the first rescue analgesic requirement measured in minutes
Measured: 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 the patients will breast feed expressed in minutes
Measured: Form the end of the surgery to the start of breast feeding (up to o 24 hours after the surgery)
Time to deambulate
Time the patients will deambulate expressed in minutes
Measured: Form the end of the surgery to the start of deambulation (up to o 24 hours after the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start7 Jan 2026
- Primary completion9 Oct 2026
- Study completion9 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Cassai, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292662
- Sponsor's protocol ID
- 6334/AO/25
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAP Block Versus ESP Block in Patients Undergoing Elective Cesarean Section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07292662
- Acronym / sponsor ID
- 6334/AO/25
- Conditions
- Cesarean Delivery, Regional Anesthesia Block
- Keywords
- ESP block, TAP block, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 9 Oct 2026 (actual)
- Study completion
- 9 Oct 2026 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Active comparator | Procedure: TAP blockPatients will undergo preoperative bilateral TAP block with ropivacaine 0.375% 20 mL per side (total 40 mL) |
| ESP block | Experimental | Procedure: ESP blockPatients will undergo preoperative bilateral ESP block with ropivacaine 0.375% 20 mL per side (total 40 mL) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 45 years
- Elective cesarean section
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP blockTAP block will be performed with with ropivacaine 0.375% 20 mL per side (total 40 mL) | Procedure or surgery | TAP block |
| ESP blockESP block will be performed with ropivacaine 0.375% 20 mL per side (total 40 mL) | Procedure or surgery | ESP block |
Primary outcome
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
9 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Delivery
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block and ESP block in people with Cesarean Delivery and Regional Anesthesia Block, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at Rest at 6 hours (time frame: 6 hours after end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.