Clinical Trials Directory

Trials / Completed

CompletedNCT04824274

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
Female
Age
19 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGfentanylFentanyl 10 mcg will be injected intrathecally during spinal anesthesia.
DRUGmorphineMorphine 75 mcg will be injected intrathecally during spinal anesthesia.
PROCEDURETransversus abdominis plane blockUltrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.
PROCEDURESham blockUltrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.

Timeline

Start date
2021-04-12
Primary completion
2022-02-18
Completion
2022-02-20
First posted
2021-04-01
Last updated
2022-02-24

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04824274. Inclusion in this directory is not an endorsement.