Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%

NCT07604376 | Recruiting

• 1 other identifier: 7633/18.04.2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether the addition of a Transversus Abdominis Plane (TAP) block improves postoperative outcomes in women undergoing cesarean section. The main questions it aims to answer are: Does the TAP block reduce postoperative pain scores compared with the traditional analgesic regimen used in our hospital? Does the TAP block decrease opioid consumption within the first 24 hours? Does the TAP block improve the 24-hour quality of recovery? Researchers will compare patients receiving the traditional analgesic regimen with patients who receive the TAP block in addition to standard care to determine differences in pain management, opioid requirements, and recovery quality. Participants will: Receive standard anesthetic and perioperative care for cesarean delivery. Be randomized to either the TAP block group or the traditional analgesic regimen group. Have postoperative pain scores assessed at predefined intervals. Have opioid consumption recorded within the first 24 hours. Complete a quality-of-recovery assessment at 24 hours postoperatively.

Conditions

Postoperative Pain; Postoperative Acute Pain

Keywords

obstetric; c-section; TAP block

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption

  24 hours

Secondary Outcomes (1)

• Recovery after cesarean section using the ObsQoR-11

  24 hours

Study Arms (2)

Postoperative (c-section) TAP block

ACTIVE COMPARATOR

Post c-section TAP block under spinal anaesthesia. Local anesthetic used in TAP block: Ropivacaine 0,2 %, dose: 0,4 ml/kg per side. Postoperative analgesia regimen: Ibuprofen every 8 hours (total dose 1200 mg/24h) and Paracetamol every 6-8 hours (total dose 4 gr/24 h). Postop analgesia score: numeric rating scale ( 0-10). Rescue analgesia if score is higher then 4: tramadol 50 mg, diluated in 20 ml NaCl 0,9%, administered slow iv ( 5 min).

Drug: Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side

"Traditional" analgesia regimen after c-section

OTHER

This arm receives the "traditional" analgesia regimen used in our hospital. This analgesia consist of: metamizol 1 gr every 8 hours, paracetamol 1gr every 8 hours, Ibuprofen every 8 hours or dexketoprofen 50 mg every 12 hours or parecoxib 40 mg every 12 hours. The use of NSAID are not mandatory and is doctor dependent. In the traditional analgesia regime we have regular opioids: tramadol 100 mg every 8-12 hours. We assess the pain scores using numeric rating scale (0-10). If pain persist usually rescue analgesia is a second opiod: meperidine 15-20 mg iv.

Drug: Postoperative pain management using "traditional" analgesia iv regime

Interventions

Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side DRUG

Postoperative (post cesarean section) TAP block using low concentration Ropivacaine ( 0,2%), volume dose weight calculated: 0,4 ml/kg per side. Total ropivacaine dose 1,6 mg/kg.

Also known as: TAP block

Postoperative (c-section) TAP block

Postoperative pain management using "traditional" analgesia iv regime DRUG

"Traditional" analgesia refers to our analgesia technique used in our hospital. Regular Tramadol, Metamizol, +/- Ibuprofen/Dexketorpofen/Parecoxib

"Traditional" analgesia regimen after c-section

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant patient anaesthesia type for c-section: spinal

You may not qualify if:

• general anaesthesia for c-section combined spinal/epidural anaethesia for c-section hipertensive emergencies in obstetrics haemorrhage emergencies in obstetrics

Sponsors & Collaborators

• Matild Keresztes: lead
• Tîrgu Mureș Emergency Clinical County Hospital, Romania: collaborator

Study Sites (1)

County Emergency Clinical Hospital of Targu Mureș

Târgu Mureş, Mureș County, 547581, Romania

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Janos Szederjesi, MD, PhD Assoc Prof

  Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș

  STUDY DIRECTOR

• Matild Keresztes

  Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matild Keresztes, Medical doctor

CONTACT

+40741784066; keresztesmatild@gmail.com

Janos Szederjesi, MD, PhD Assoc Prof

CONTACT

+40745316221; yangzi37@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

RO (1)