NCT07292662

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Oct 2027

First Submitted

Initial submission to the registry

September 12, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

September 12, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

ESP blockTAP blockcesarean section

Outcome Measures

Primary Outcomes (1)

  • 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

    6 hours after end of surgery

Secondary Outcomes (9)

  • Pain at Rest at 12 hours

    12 hours after end of surgery

  • Pain at Rest at 24 hours

    24 hours after end of surgery

  • Pain at Movement at 6 hours

    6 hours after end of surgery

  • Pain at Movement at 12 hours

    12 hours after end of surgery

  • Pain at Movement at 24 hours

    24 hours after end of surgery

  • +4 more secondary outcomes

Study Arms (2)

TAP block

ACTIVE COMPARATOR

Patients will undergo preoperative bilateral TAP block with ropivacaine 0.375% 20 mL per side (total 40 mL)

Procedure: TAP block

ESP block

EXPERIMENTAL

Patients will undergo preoperative bilateral ESP block with ropivacaine 0.375% 20 mL per side (total 40 mL)

Procedure: ESP block

Interventions

TAP blockPROCEDURE

TAP block will be performed with with ropivacaine 0.375% 20 mL per side (total 40 mL)

TAP block
ESP blockPROCEDURE

ESP block will be performed with ropivacaine 0.375% 20 mL per side (total 40 mL)

ESP block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45 years
  • Elective cesarean section
  • Ability to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Padua

Padova, 35127, Italy

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2025

First Posted

December 18, 2025

Study Start

January 7, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations