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NCT Number: NCT07145619

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Samsun University Training and Research Hospital

Samsun, 55090, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet Gökhan Taflan, MD

CONTACT

[email protected]

+9005352114070

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Obstetric Quality of Recovery-10 (ObsQoR-10) Score at 24 Hours Postoperatively

    Time frame: 24 hours after surgery

    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

  1. Total Opioid Consumption in 24 Hours

    Time frame: 0-24 hours postoperatively

    Total intravenous morphine consumption (in milligrams) recorded from PCA device logs in the first 24 hours after surgery.

  2. Numerical Rating Scale (NRS) Pain Scores

    Time frame: 0-24 hours postoperatively

    Pain intensity measured using a Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at specified postoperative time points.

  3. Time to First Breastfeeding

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

    Time interval in minutes from the completion of surgery to initiation of breastfeeding.

  4. Time to First Mobilization

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

    Time interval in hours from completion of surgery to the first mobilization with assistance or independently.

  5. Time to Hospital Discharge

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

    Time interval from the end of surgery until the patient is formally discharged from hospital care.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Gökhan Taflan, MD

CONTACT

[email protected]

+905352114070

Sponsors and collaborators

Lead sponsor

MEHMET GÖKHAN TAFLAN

Other

Registry information

Official study title

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

Acronym: QoR-TAP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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