Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative analgesia using TAP block, Ropivacaine 0,2%, volume: 0,4 ml/kg per side, Postoperative pain management using "traditional" analgesia iv regime.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Postoperative Acute Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Postoperative 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. - Drug Postoperative pain management using "traditional" analgesia iv regime
"Traditional" analgesia refers to our analgesia technique used in our hospital. Regular Tramadol, Metamizol, +/- Ibuprofen/Dexketorpofen/Parecoxib
Primary outcome measures
- Postoperative opioid consumption [Time frame: 24 hours]
Secondary outcome measures (1)
- Recovery after cesarean section using the ObsQoR-11 [Time frame: 24 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Romania · 1 center
- County Emergency Clinical Hospital of Targu Mureș — Târgu Mureş
Identifiers
NCT: NCT07604376 · 7633/18.04.2024 · 7633/18.04.2024