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

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Drug: morphine; Drug: fentanyl; Procedure: Transversus abdominis plane block; Procedure: Sham block

• Registration Number: NCT04824274
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-04-01
• Study Start: 2021-04-12
• Status Verified: 2022-02
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-20
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transversus abdominis plane block and intrathecal fentanyl	Transversus abdominis plane block	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.
Intrathecal morphine	Sham block	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.
Intrathecal morphine	morphine	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.
Transversus abdominis plane block and intrathecal fentanyl	fentanyl	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.

Primary Outcome Measures

Name	Time	Method
Pain score with movement at 24 hours after delivery	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of