About this trial
This prospective, assessor-blinded observational cohort study will investigate the effect of adding bilateral ultrasound-guided transversus abdominis plane (TAP) block to standard intrathecal morphine (ITM) analgesia on the quality of recovery in women undergoing elective cesarean delivery under spinal anesthesia. All participants will receive ITM as part of routine spinal anesthesia. The TAP group will receive an additional bilateral ultrasound-guided TAP block at the end of surgery, while the control group will not receive any additional block. Both groups will receive standardized postoperative analgesia with intravenous patient-controlled analgesia (IV PCA). The primary outcome is the quality of recovery at 24 hours postoperatively, measured using the validated Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Secondary outcomes include Numerical Rating Scale (NRS) pain scores, time to first breastfeeding, time to mobilization, time to hospital discharge, and total opioid consumption in the first 24 hours after surgery. Outcome assessors will be blinded to group allocation. The study aims to determine whether TAP block enhances functional recovery, reduces pain, and decreases analgesic requirements when used alongside ITM in cesarean delivery patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18-45 years
Singleton pregnancy
ASA physical status II-III
Scheduled elective lower segment cesarean delivery under spinal anesthesia with intrathecal morphine (ITM) as standard care
Disqualifiers
Contraindication to spinal anesthesia or TAP block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
Chronic opioid use or opioid/alfa-2 agonist intolerance
Severe preeclampsia, HELLP syndrome, significant hepatic or renal impairment
Urgent or emergent cesarean section (Category 1)
Trial population
Women undergoing elective cesarean delivery under spinal anesthesia with intrathecal morphine at a tertiary university hospital. Two observational cohorts will be followed: one receiving only intrathecal morphine and the other receiving intrathecal morphine plus bilateral ultrasound-guided TAP block.
Trial design
Cohort
Prospective
Treatments tested in this trial
Spinal Anesthesia with Intrathecal Morphine Only
Other interventionElective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care. No additional regional block is performed. Postoperative analgesia is maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs as per institutional protocol.
Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block
Other interventionElective cesarean delivery performed under spinal anesthesia with the addition of 100 micrograms intrathecal morphine (ITM) as part of standard clinical care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. The TAP block will be performed in-plane with a high-frequency linear probe, using 0.25% bupivacaine, 20 mL per side, injected between the internal oblique and transversus abdominis muscles. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) morphine and multimodal analgesia, including scheduled paracetamol and NSAIDs.
Treatment groups
Trial outcomes
Primary outcomes
Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively
Total score on the validated Turkish version of the Obstetric Quality of Recovery-10 questionnaire (ObsQoR-10-T), measured by a blinded assessor. Scores range from 0 to 100, with higher scores indicating better recovery.
Secondary outcomes
Total Opioid Consumption in 24 Hours
Total intravenous morphine consumption (in milligrams) recorded from PCA device logs in the first 24 hours after surgery.
Numerical Rating Scale (NRS) Pain Scores
Pain intensity measured using a Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at specified postoperative time points.
Time to First Breastfeeding
Time interval in minutes from the completion of surgery to initiation of breastfeeding.
Time to First Mobilization
Time interval in hours from completion of surgery to the first mobilization with assistance or independently.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MEHMET GÖKHAN TAFLAN
Lead sponsor
Samsun University
Sponsor institution