TAP Block With Intrathecal Fentanyl vs. Intrathecal Morphine in Cesarean Delivery

Study Overview
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Brief Summary
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This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia.

Detailed Description
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Healthy mothers scheduled to undergo elective cesarean delivery under spinal anesthesia will be randomly allocated to receive either TAP block plus intrathecal fentanyl (Group TF) or intrathecal morphine (Group M). Primary outcome is pain score with movement at postoperative 24 hours.

Official Title
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Transversus Abdominis Plane Block With Intrathecal Fentanyl Versus Intrathecal Morphine in Cesarean Delivery: A Randomized, Controlled, Noninferiority Trial

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: fentanyl
* Drug: morphine
* Procedure: Transversus abdominis plane block
* Procedure: Sham block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult full-term parturients scheduled to undergo elective cesarean delivery under spinal anesthesia Exclusion Criteria: Contraindication to spinal anesthesia Any chronic pain unrelated pregnancy current opioid medication use BMI more than 40 kg m-2 History of drug allergy or hypersensitivity to fentanyl, morphine, ropivacaine, acetaminophen, NSAIDs, bupivacaine, ramosetron, ondansetron, nalbuphine, Naloxone, metoclopramide infection of abdominal wall Pregnancy-induced hypertension known cardiovascular disease Known fetal anomaly Any sign of onset of labor

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transversus abdominis plane block and intrathecal fentanyl<br>Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + fentanyl 10 mcg. Following the completion of surgery, ultrasound-guided bilateral transversus abdominis plane block will be done with 0.375% ropivacaine 15 ml per each side. | Drug: fentanyl<br>* Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.<br>Procedure: Transversus abdominis plane block<br>* Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.<br>|
| Active Comparator: Intrathecal morphine<br>Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + morphine 75 mcg. Following the completion of surgery, sham block will be done using normal saline. | Drug: morphine<br>* Morphine 75 mcg will be injected intrathecally during spinal anesthesia.<br>* Other names: Morphine sulfate;Procedure: Sham block<br>* Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score with movement at 24 hours after delivery | Pain score with movement at 24hr after delivery, using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable) | at 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravenous fentanyl consumption | cumulative fentanyl consumption via intravenous patient-controlled analgesia | at 6, 12, 18, 24, 48 hours after delivery | 
| Pain score at rest | Pain score at rest using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable) | at 6, 12, 18, 24, 48 hours after delivery | 
| Pain score with movement | Pain score with movement using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable) | at 6, 12, 18, 48 hours after delivery | 
| time to first opioid request | time to first intravenous fentanyl administration from delivery | during hospital stay, an average of 3 days | 
| number of patients requiring rescue analgesics | number of patients requiring rescue analgesics | During the first 48 hour-period after delivery | 
| Incidence of nausea | Proportion of patients who experienced nausea | During the first 48 hour-period after delivery | 
| Incidence of vomiting | Proportion of patients who experienced vomiting | During the first 48 hour-period after delivery | 
| Incidence of pruritus | Proportion of patients who experienced pruritus | During the first 48 hour-period after delivery | 
| Incidence of sedation | Proportion of patients who experienced sedation | During the first 48 hour-period after delivery | 
| Incidence of respiratory depression | Proportion of patients who experienced respiratory depression | During the first 48 hour-period after delivery | 
| Nausea severity | Nausea severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe | During the first 48 hour-period after delivery | 
| Pruritus severity | Pruritus severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe | During the first 48 hour-period after delivery | 
| Patient satisfaction for overall postoperative managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied) | Patient satisfaction score for overall postoperative pain managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied) | During the first 48 hour-period after delivery | 
| Hospital length of stay | Hospital length of stay (day) | From admission to hospital discharge, an average of 3 days | 
| Apgar Score | Apgar Score of fetus | at 1 minute, at 5 minutes | 
| Umbilical arterial pH | Umbilical arterial pH | immediately after delivery | 
| Umbilical arterial PO2 | Umbilical arterial PO2 | immediately after delivery | 
| Umbilical arterial PCO2 | Umbilical arterial PCO2 | immediately after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia, cesarean section, postoperative analgesia, transversus abdominis plane block, morphine, fentanyl