Effect of Bilateral Ultrasound-Guided TAP Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine
NCT ID: NCT07145619
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2025-09-01
2026-02-25
Brief Summary
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Detailed Description
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In this prospective, assessor-blinded observational cohort study, all eligible patients undergoing elective cesarean delivery under spinal anesthesia at our institution will receive ITM as part of standard practice. Participants will be managed in two groups based on postoperative analgesia:
* TAP Group: Bilateral ultrasound-guided TAP block performed at the end of surgery in addition to ITM.
* Control Group: ITM only, without additional regional block.
Both groups will receive standardized postoperative analgesia via intravenous patient-controlled analgesia (IV PCA). Data will be collected prospectively, and the outcome assessor responsible for postoperative evaluation will be blinded to group allocation.
Primary Outcome:
* Quality of recovery at 24 hours postoperatively, measured using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire.
Secondary Outcomes:
* Numerical Rating Scale (NRS) pain scores
* Time to first breastfeeding
* Time to first mobilization
* Time to hospital discharge
* Total opioid consumption within the first 24 hours
By analyzing these parameters, the study aims to clarify whether the addition of TAP block to ITM-based analgesia can enhance recovery quality, improve functional outcomes, reduce pain intensity, and decrease opioid consumption in cesarean delivery patients. Findings from this research could inform best practice guidelines for postoperative pain management in obstetric anesthesia.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ITM
Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care. No additional regional block will be performed. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group
Spinal Anesthesia with Intrathecal Morphine Only
Elective 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.
ITM + TAP
Patients undergoing elective cesarean delivery under spinal anesthesia with 100 µg intrathecal morphine (ITM) as part of standard care, plus bilateral ultrasound-guided transversus abdominis plane (TAP) block performed at the end of surgery. Postoperative analgesia will be maintained with intravenous patient-controlled analgesia (IV PCA) using morphine, along with multimodal analgesia.Approximately 75 participants will be enrolled in this group
Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block
Elective 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.
Interventions
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Spinal Anesthesia with Intrathecal Morphine Only
Elective 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
Elective 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.
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* ASA physical status II-III
* Scheduled elective lower segment cesarean delivery under spinal anesthesia with intrathecal morphine (ITM) as standard care
* Able to understand study procedures, provide written informed consent, and reliably use IV PCA
* Able to complete ObsQoR-10-T assessments (with trained assistance if needed)
Exclusion Criteria
* 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)
* Cognitive impairment or communication difficulty preventing accurate assessment
* Prior major abdominal surgery (other than previous cesarean delivery)
* Body mass index (BMI) \> 40 kg/m²
* Major psychiatric illness (e.g., major depressive disorder, generalized anxiety disorder, psychosis) that may affect pain perception or quality of recovery
18 Years
45 Years
FEMALE
No
Sponsors
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MEHMET GÖKHAN TAFLAN
OTHER
Responsible Party
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MEHMET GÖKHAN TAFLAN
Principal Investigator, Specialist in Anesthesiology
Principal Investigators
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Mehmet Gökhan Taflan, MD
Role: PRINCIPAL_INVESTIGATOR
Samsun Education and Research Hospital
Locations
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Samsun University Training and Research Hospital
Samsun, Samsun, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GOKAEK2024/18/8
Identifier Type: OTHER
Identifier Source: secondary_id
ITMTAPObsQoRMT2025
Identifier Type: -
Identifier Source: org_study_id