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

Effect of Bilateral Ultrasound-Guided Transversus Abdominis Plane Block on Quality of Recovery in Cesarean Delivery Patients Receiving Intrathecal Morphine: A Prospective Observational Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07145619
Acronym
QoR-TAP
Enrollment
160
Registered
2025-08-28
Start date
2025-09-01
Completion date
2026-07-30
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric Anesthesia, Postoperative Pain Management, Recovery From Anesthesia

Keywords

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

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.

Detailed description

Effective postoperative analgesia is essential for optimizing maternal recovery after cesarean delivery, promoting early mobilization, and supporting breastfeeding initiation. Spinal anesthesia with intrathecal morphine (ITM) is commonly used due to its long-lasting analgesia; however, it may not provide complete abdominal wall analgesia and can be associated with opioid-related side effects. The transversus abdominis plane (TAP) block is an ultrasound-guided regional anesthesia technique that provides somatic analgesia to the anterior abdominal wall by targeting the anterior rami of the thoracolumbar spinal nerves (T6-L1). When combined with ITM, TAP block may further improve recovery quality, reduce opioid requirements, and facilitate earlier return to daily activities. 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.

Interventions

OTHERSpinal 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.

OTHERSpinal 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.

Sponsors

MEHMET GÖKHAN TAFLAN
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively24 hours after surgeryTotal 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

MeasureTime frameDescription
Total Opioid Consumption in 24 Hours0-24 hours postoperativelyTotal intravenous morphine consumption (in milligrams) recorded from PCA device logs in the first 24 hours after surgery.
Numerical Rating Scale (NRS) Pain Scores0-24 hours postoperativelyPain intensity measured using a Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at specified postoperative time points.
Time to First BreastfeedingAssessed from end of surgery to first breastfeeding attempt, up to 24 hoursTime interval in minutes from the completion of surgery to initiation of breastfeeding.
Time to First MobilizationAssessed from the end of surgery to first mobilization attempt, up to 24 hours postoperativelyTime interval in hours from completion of surgery to the first mobilization with assistance or independently.
Time to Hospital DischargeAssessed from the end of surgery to official hospital discharge, up to 7 days postoperativelyTime interval from the end of surgery until the patient is formally discharged from hospital care.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORMehmet Gökhan Taflan, MD

Samsun Education and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026