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

NCT04824274 | Completed

• 1 other identifier: 2012-167-1185
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

transversus abdominis plane block; morphine; fentanyl; spinal anesthesia; cesarean section; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Intravenous fentanyl consumption

  at 6, 12, 18, 24, 48 hours after delivery

• Pain score at rest

  at 6, 12, 18, 24, 48 hours after delivery

• Pain score with movement

  at 6, 12, 18, 48 hours after delivery

• time to first opioid request

  during hospital stay, an average of 3 days

• number of patients requiring rescue analgesics

  During the first 48 hour-period after delivery

Study Arms (2)

Transversus abdominis plane block and intrathecal fentanyl

EXPERIMENTAL

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; Procedure: Transversus abdominis plane block

Intrathecal morphine

ACTIVE COMPARATOR

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; Procedure: Sham block

Interventions

fentanyl DRUG

Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.

Transversus abdominis plane block and intrathecal fentanyl

morphine DRUG

Morphine 75 mcg will be injected intrathecally during spinal anesthesia.

Also known as: Morphine sulfate

Intrathecal morphine

Transversus abdominis plane block PROCEDURE

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

Transversus abdominis plane block and intrathecal fentanyl

Sham block PROCEDURE

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

Intrathecal morphine

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult full-term parturients scheduled to undergo elective cesarean delivery under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (4)

• Cole J, Hughey S, Longwell J. Transversus abdominis plane block and intrathecal morphine use in cesarean section: a retrospective review. Reg Anesth Pain Med. 2019 Sep 13:rapm-2019-100483. doi: 10.1136/rapm-2019-100483. Online ahead of print.

  PMID: 31519816 BACKGROUND

• Patel SD, Sharawi N, Sultan P. Local anaesthetic techniques for post-caesarean delivery analgesia. Int J Obstet Anesth. 2019 Nov;40:62-77. doi: 10.1016/j.ijoa.2019.06.002. Epub 2019 Jun 8.

  PMID: 31262444 BACKGROUND

• Kwikiriza A, Kiwanuka JK, Firth PG, Hoeft MA, Modest VE, Ttendo SS. The analgesic effects of intrathecal morphine in comparison with ultrasound-guided transversus abdominis plane block after caesarean section: a randomised controlled trial at a Ugandan regional referral hospital. Anaesthesia. 2019 Feb;74(2):167-173. doi: 10.1111/anae.14467. Epub 2018 Nov 1.

  PMID: 30383289 BACKGROUND

• Park SK, Kim Y, Kim H, Kim JT. Transversus abdominis plane block combined with intrathecal fentanyl versus intrathecal morphine for post-cesarean analgesia: a randomized non-inferiority clinical trial. Reg Anesth Pain Med. 2025 Jan 21:rapm-2024-106044. doi: 10.1136/rapm-2024-106044. Online ahead of print.

  PMID: 39842942 DERIVED

MeSH Terms

Interventions

Fentanyl; Morphine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 1, 2021
• Study Start: April 12, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 20, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

KR (1)