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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824274
• Other study ID #: 2012-167-1185
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: February 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 20, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. pii: rapm-2019-100483. doi: 10.1136/rapm-2019-100483. [Epub ahead of print] — View 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. — View 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. Review. — View Citation

Outcome

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