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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04824274

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Drug: fentanyl Drug: morphine Procedure: Transversus abdominis plane block Procedure: Sham block	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 12, 2021

Actual Primary Completion Date :

Feb 18, 2022

Actual Study Completion Date :

Feb 20, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

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.

Drug: fentanyl

Fentanyl 10 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.

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.

Drug: morphine

Morphine 75 mcg will be injected intrathecally during spinal anesthesia.

Other Names:

Morphine sulfate

Procedure: Sham block

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

Outcome Measures

Primary Outcome Measures

Pain score with movement at 24 hours after delivery [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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