Skip to main content
OpenTrials
Completed

NCT Number: NCT04824274

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Section

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.

Morphine

Drug

Morphine 75 mcg will be injected intrathecally during spinal anesthesia.

Other names: Morphine sulfate

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.

Sham Block

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. Intravenous fentanyl consumption

    Time frame: at 6, 12, 18, 24, 48 hours after delivery

    cumulative fentanyl consumption via intravenous patient-controlled analgesia

  2. 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)

  3. 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)

  4. time to first opioid request

    Time frame: during hospital stay, an average of 3 days

    time to first intravenous fentanyl administration from delivery

  5. number of patients requiring rescue analgesics

    Time frame: During the first 48 hour-period after delivery

    number of patients requiring rescue analgesics

  6. Incidence of nausea

    Time frame: During the first 48 hour-period after delivery

    Proportion of patients who experienced nausea

  7. Incidence of vomiting

    Time frame: During the first 48 hour-period after delivery

    Proportion of patients who experienced vomiting

  8. Incidence of pruritus

    Time frame: During the first 48 hour-period after delivery

    Proportion of patients who experienced pruritus

  9. Incidence of sedation

    Time frame: During the first 48 hour-period after delivery

    Proportion of patients who experienced sedation

  10. Incidence of respiratory depression

    Time frame: During the first 48 hour-period after delivery

    Proportion of patients who experienced respiratory depression

  11. 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

  12. 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

  13. 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)

  14. Hospital length of stay

    Time frame: From admission to hospital discharge, an average of 3 days

    Hospital length of stay (day)

  15. Apgar Score

    Time frame: at 1 minute, at 5 minutes

    Apgar Score of fetus

  16. Umbilical arterial pH

    Time frame: immediately after delivery

    Umbilical arterial pH

  17. Umbilical arterial PO2

    Time frame: immediately after delivery

    Umbilical arterial PO2

  18. Umbilical arterial PCO2

    Time frame: immediately after delivery

    Umbilical arterial PCO2

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.