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

Overview

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 Title of Study: “Transversus Abdominis Plane Block With Intrathecal Fentanyl Versus Intrathecal Morphine in Cesarean Delivery: A Randomized, Controlled, Noninferiority Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 18, 2022

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.

Interventions

  • Drug: fentanyl
    • Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.
  • Drug: morphine
    • Morphine 75 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.
  • Procedure: Sham block
    • Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Pain score with movement at 24 hours after delivery
    • Time Frame: 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 Measures

  • Intravenous fentanyl consumption
    • Time Frame: at 6, 12, 18, 24, 48 hours after delivery
    • cumulative fentanyl consumption via intravenous patient-controlled analgesia
  • Pain score at rest
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: during hospital stay, an average of 3 days
    • time to first intravenous fentanyl administration from delivery
  • number of patients requiring rescue analgesics
    • Time Frame: During the first 48 hour-period after delivery
    • number of patients requiring rescue analgesics
  • Incidence of nausea
    • Time Frame: During the first 48 hour-period after delivery
    • Proportion of patients who experienced nausea
  • Incidence of vomiting
    • Time Frame: During the first 48 hour-period after delivery
    • Proportion of patients who experienced vomiting
  • Incidence of pruritus
    • Time Frame: During the first 48 hour-period after delivery
    • Proportion of patients who experienced pruritus
  • Incidence of sedation
    • Time Frame: During the first 48 hour-period after delivery
    • Proportion of patients who experienced sedation
  • Incidence of respiratory depression
    • Time Frame: During the first 48 hour-period after delivery
    • Proportion of patients who experienced respiratory depression
  • Nausea severity
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: From admission to hospital discharge, an average of 3 days
    • Hospital length of stay (day)
  • Apgar Score
    • Time Frame: at 1 minute, at 5 minutes
    • Apgar Score of fetus
  • Umbilical arterial pH
    • Time Frame: immediately after delivery
    • Umbilical arterial pH
  • Umbilical arterial PO2
    • Time Frame: immediately after delivery
    • Umbilical arterial PO2
  • Umbilical arterial PCO2
    • Time Frame: immediately after delivery
    • Umbilical arterial PCO2

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin-Tae Kim, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jin-Tae Kim, MD, PhD, Principal Investigator, Seoul National University Hospital

References

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.

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.

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