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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2022-02-20

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.

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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.

Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transversus abdominis plane block and intrathecal 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.

Group Type EXPERIMENTAL

fentanyl

Intervention Type DRUG

Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.

Transversus abdominis plane block

Intervention Type PROCEDURE

Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.

Intrathecal 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.

Group Type ACTIVE_COMPARATOR

morphine

Intervention Type DRUG

Morphine 75 mcg will be injected intrathecally during spinal anesthesia.

Sham block

Intervention Type PROCEDURE

Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.

Interventions

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fentanyl

Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.

Intervention Type DRUG

morphine

Morphine 75 mcg will be injected intrathecally during spinal anesthesia.

Intervention Type DRUG

Transversus abdominis plane block

Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.

Intervention Type PROCEDURE

Sham block

Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.

Intervention Type PROCEDURE

Other Intervention Names

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Morphine sulfate

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

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No