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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%

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• pregnant patient anaesthesia type for c-section: spinal

Locations
Other Locations
Romania
County Emergency Clinical Hospital of Targu Mureș
RECRUITING
Târgu Mureş
Contact Information
Primary
Matild Keresztes, Medical doctor
keresztesmatild@gmail.com
+40741784066
Backup
Janos Szederjesi, MD, PhD Assoc Prof
yangzi37@gmail.com
+40745316221
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 70
Treatments
Active_comparator: Postoperative (c-section) TAP block
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).
Other: Traditional analgesia regimen after c-section
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.
Related Therapeutic Areas
Sponsors
Collaborators: Tîrgu Mureș Emergency Clinical County Hospital, Romania
Leads: Matild Keresztes

This content was sourced from clinicaltrials.gov