Effect of Bilateral Ultrasound-Guided TAP Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine

NCT07145619 | Recruiting

• 2 other identifiers: ITMTAPObsQoRMT2025GOKAEK2024/18/8
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain Management; Obstetric Anesthesia; Recovery From Anesthesia

Keywords

Cesarean delivery; Spinal anesthesia; Intrathecal morphine; Transversus abdominis plane block; Postoperative pain; Obstetric anesthesia; Quality of recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after surgery

Secondary Outcomes (5)

• Total Opioid Consumption in 24 Hours

  0-24 hours postoperatively

• Numerical Rating Scale (NRS) Pain Scores

  0-24 hours postoperatively

• Time to First Breastfeeding

  Assessed from end of surgery to first breastfeeding attempt, up to 24 hours

• Time to First Mobilization

  Assessed from the end of surgery to first mobilization attempt, up to 24 hours postoperatively

• Time to Hospital Discharge

  Assessed from the end of surgery to official hospital discharge, up to 7 days postoperatively

Study Arms (2)

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

Other: Spinal Anesthesia with Intrathecal Morphine Only

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

Other: Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block

Interventions

Spinal Anesthesia with Intrathecal Morphine Only OTHER

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

Spinal Anesthesia with Intrathecal Morphine plus Bilateral TAP Block OTHER

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.

ITM + TAP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• MEHMET GÖKHAN TAFLAN: lead

Study Sites (1)

Samsun University Training and Research Hospital

Samsun, Samsun, 55090, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Mehmet Gökhan Taflan, MD

  Samsun Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Gökhan Taflan, MD

CONTACT

+905352114070; drmehmettaflan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Specialist in Anesthesiology

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available beginning 12 months after the study's completion date and remain available for 5 years.
• Access Criteria: Qualified researchers affiliated with academic institutions or research organizations, who provide a methodologically sound proposal and relevant ethics approval, may request access. Requests will be reviewed by the principal investigator. Approved researchers will receive access to de-identified datasets and related documentation via secure institutional data sharing platforms.

Locations

TU (1)