Clinical trial NCT04824274: TAP Block With Intrathecal Fentanyl vs. Intrathecal Morphine in Cesarean Delivery
Official title: Transversus Abdominis Plane Block With Intrathecal Fentanyl Versus Intrathecal Morphine in Cesarean Delivery: A Randomized, Controlled, Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: transversus abdominis plane block
morphine
fentanyl
spinal anesthesia
cesarean section
postoperative analgesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score with movement at 24 hours after delivery
timeFrame: at 24 hours after delivery
Secondary outcomes:
measure: Intravenous fentanyl consumption
timeFrame: at 6, 12, 18, 24, 48 hours after delivery
measure: Pain score at rest
timeFrame: at 6, 12, 18, 24, 48 hours after delivery
measure: Pain score with movement
timeFrame: at 6, 12, 18, 48 hours after delivery
measure: time to first opioid request
timeFrame: during hospital stay, an average of 3 days
measure: number of patients requiring rescue analgesics
timeFrame: During the first 48 hour-period after delivery
measure: Incidence of nausea
timeFrame: During the first 48 hour-period after delivery
measure: Incidence of vomiting
timeFrame: During the first 48 hour-period after delivery
measure: Incidence of pruritus
timeFrame: During the first 48 hour-period after delivery
measure: Incidence of sedation
timeFrame: During the first 48 hour-period after delivery
measure: Incidence of respiratory depression
timeFrame: During the first 48 hour-period after delivery
measure: Nausea severity
timeFrame: During the first 48 hour-period after delivery
measure: Pruritus severity
timeFrame: During the first 48 hour-period after delivery
measure: Patient satisfaction for overall postoperative managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied)
timeFrame: During the first 48 hour-period after delivery
measure: Hospital length of stay
timeFrame: From admission to hospital discharge, an average of 3 days
measure: Apgar Score
timeFrame: at 1 minute, at 5 minutes
measure: Umbilical arterial pH
timeFrame: immediately after delivery
measure: Umbilical arterial PO2
timeFrame: immediately after delivery
measure: Umbilical arterial PCO2
timeFrame: immediately after delivery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.