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

Seoul National University

Status: Completed

Conditions: Cesarean Section

Treatments: Procedure: Sham block; Procedure: Transversus abdominis plane block; Drug: fentanyl; Drug: morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT04824274

2012-167-1185

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Transversus abdominis plane block and intrathecal fentanyl

Experimental group

Description:

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.

Treatment:

Drug: fentanyl

Procedure: Transversus abdominis plane block

Intrathecal morphine

Active Comparator group

Description:

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.

Treatment:

Drug: morphine

Procedure: Sham block