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| ID | Type | Description | Link |
|---|---|---|---|
| GOKAEK2024/18/8 | Other Identifier | Samsun University |
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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.
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:
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:
Secondary Outcomes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption in 24 Hours | Total intravenous morphine consumption (in milligrams) recorded from PCA device logs in the first 24 hours after surgery. | 0-24 hours postoperatively |
| Numerical Rating Scale (NRS) Pain Scores |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Gökhan Taflan, MD | Contact | +905352114070 | drmehmettaflan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mehmet Gökhan Taflan, MD | Samsun Education and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsun University Training and Research Hospital | Recruiting | Samsun | Samsun | 55090 | Turkey (TĂĽrkiye) |
De-identified individual participant data (IPD), data dictionary, and statistical analysis code will be shared with qualified researchers upon reasonable request, after publication of the main results. Data will be available 12 months after study completion and for up to 5 years. Requests must be accompanied by a methodologically sound proposal and relevant ethics approval.
IPD and supporting information will be available beginning 12 months after the study's completion date and remain available for 5 years.
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.
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| 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. |
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Pain intensity measured using a Numerical Rating Scale (0 = no pain, 10 = worst pain imaginable) at specified postoperative time points.
| 0-24 hours postoperatively |
| Time to First Breastfeeding | Time interval in minutes from the completion of surgery to initiation of breastfeeding. | Assessed from end of surgery to first breastfeeding attempt, up to 24 hours |
| Time to First Mobilization | Time interval in hours from completion of surgery to the first mobilization with assistance or independently. | Assessed from the end of surgery to first mobilization attempt, up to 24 hours postoperatively |
| Time to Hospital Discharge | Time interval from the end of surgery until the patient is formally discharged from hospital care. | Assessed from the end of surgery to official hospital discharge, up to 7 days postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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