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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07604376
Enrollment
70
Registered
2026-05-22
Start date
2024-03-01
Completion date
2027-12-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Acute Pain, Postoperative Pain

Keywords

obstetric, c-section, TAP block

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.

Detailed description

This study will evaluate the effectiveness of a Transversus Abdominis Plane (TAP) block for postoperative analgesia in patients undergoing cesarean section. Participants randomized to the TAP group will receive an ultrasound-guided TAP block with ropivacaine 0.2% at a dose of 0.4 ml/kg per side. The block will be performed at the end of surgery, under spinal anesthesia, using a linear probe with a lateral approach. After aseptic preparation of the skin, sterile probe covering, and operator sterile technique, the muscle layers will be identified sonographically. A 50 mm or 100 mm needle will be inserted in-plane. Following confirmation of the fascial plane and negative aspiration for blood, local anesthetic will be administered in 5 ml increments, with repeated aspiration to avoid intravascular injection. Postoperative analgesia in the TAP group will consist of ibuprofen every 8 hours (max 1200mg/day) and paracetamol every 6-8 hours (max 4 gr/day), with tramadol 50 mg available as rescue analgesic. Participants in the control group (non-TAP) will receive the traditional analgesic regimen used in our hospital: metamizole every 8 hours ( max 3 gr/day), NSAIDs (ibuprofen, dexketoprofen, pareecoxib), paracetamol every 6-8 hours ( max 4 gr/day), and scheduled tramadol, every 8-12 hour ( max 300 mg/day) Pain assessment and outcomes: Participants will remain in the obstetric intensive care unit (ICU) for the first 12-24 hours after cesarean delivery, after which they will be transferred to the ward. Pain will be assessed using the Numeric Rating Scale (NRS) at rest, during mobilization, during breastfeeding, and while standing/walking. The target NRS is ≤4. Opioid consumption will be recorded during the first 24 hours. Quality of recovery: At 24 hours postoperatively, participants will complete the ObsQoR-11 questionnaire, a validated recovery tool consisting of 11 statements. It comprises 11 items that assess recovery across the key domains of physical comfort, physical independence, psychological well-being, emotional state, and pain control. Each item is rated by the patient on a 0-10 numerical rating scale, where 0 corresponds to the poorest recovery or complete disagreement with the statement, and 10 corresponds to the best possible recovery or complete agreement with the statement. The individual item scores are summed to yield a total score ranging from 0 to 110, with higher scores reflecting a better quality of postoperative recovery. The ObsQoR-11 therefore provides a quantitative, standardized, and patient-centered measure of recovery, allowing for both within-group and between-group comparisons in clinical trials.

Interventions

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

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.

DRUGPostoperative pain management using "traditional" analgesia iv regime

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

Sponsors

Matild Keresztes
Lead SponsorOTHER
Tîrgu Mureș Emergency Clinical County Hospital, Romania
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

pregnant patient anaesthesia type for c-section: spinal

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Postoperative opioid consumption24 hours

Secondary

MeasureTime frameDescription
Recovery after cesarean section using the ObsQoR-1124 hoursThe ObsQoR-11 is an 11-item, self-report questionnaire used to assess recovery after childbirth, particularly caesarean delivery after 24 hours. It measures four key aspects of recovery: physical comfort, emotional state, physical independence, and the ability to care for the newborn. A higher ObsQoR-11 score indicates better recovery

Countries

Romania

Contacts

CONTACTMatild Keresztes, Medical doctor
keresztesmatild@gmail.com+40741784066
CONTACTJanos Szederjesi, MD, PhD Assoc Prof
yangzi37@gmail.com+40745316221
STUDY_DIRECTORJanos Szederjesi, MD, PhD Assoc Prof

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

PRINCIPAL_INVESTIGATORMatild Keresztes

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026