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

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: fentanyl; Procedure: Transversus abdominis plane block; Drug: morphine; Procedure: Sham block

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: fentanyl; Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.; Procedure: Transversus abdominis plane block; Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.
Active Comparator: 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.	Drug: morphine; Morphine 75 mcg will be injected intrathecally during spinal anesthesia.; Other Names: Morphine sulfate; Procedure: Sham block; Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 20, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: cesarean section; morphine; fentanyl; spinal anesthesia; transversus abdominis plane block; postoperative analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: 2012-167-1185

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No