TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics

Sponsor

Universitas Padjadjaran (Other)

Overall Status

Completed

CT.gov ID

NCT06089200

Collaborator

(none)

Enrollment

Location

Arms

2.1

Actual Duration (Months)

20.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this randomized controlled trial is to compare the effect of TAP block vs spinal morphine for post caesarean section analgesics. The main questions it aims to answer are:

Which post op analgesic method works better for patients who underwent caesarean section
The number of additional opioid needed

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: Transversus Abdominal Plane Block Procedure: Spinal Morphine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Post-operative Analgetics With Transversus Abdominis Block and Spinal Morphine for Post-Caesarean Section: A Randomised Trial Study

Actual Study Start Date :

Feb 23, 2023

Actual Primary Completion Date :

Apr 28, 2023

Actual Study Completion Date :

Apr 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transversus Abdominis Plane Block Twenty two subjects were given postoperative block administration in the transversus abdominis area on each side with ultrasonography (USG) guidance	Procedure: Transversus Abdominal Plane Block 20 cc of bupivacaine 0.2% was given to the transversus abdominis plane
Active Comparator: Spinal Morphine Twenty two subjects were given additional morphine 100 µg intrathecally	Procedure: Spinal Morphine 100 µg was administered intrathecally preoperatively

Arm

Intervention/Treatment

Experimental: Transversus Abdominis Plane Block

Twenty two subjects were given postoperative block administration in the transversus abdominis area on each side with ultrasonography (USG) guidance

Procedure: Transversus Abdominal Plane Block

20 cc of bupivacaine 0.2% was given to the transversus abdominis plane

Active Comparator: Spinal Morphine

Twenty two subjects were given additional morphine 100 µg intrathecally

Procedure: Spinal Morphine

100 µg was administered intrathecally preoperatively

Outcome Measures

Primary Outcome Measures

Length of time the patient needed the first additional opioid analgesics [24 hours post operative]
Total need for additional opioids [24 hours post operative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Indicated for caesarean section as assessed by Obstetricians
ASA II
Consented to be included in the study

Exclusion Criteria:

Allergy history
Spinal converted to general anesthesia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasan Sadikin General Hospital	Bandung	Jawa Barat	Indonesia	40161

Sponsors and Collaborators

Universitas Padjadjaran

Investigators

Principal Investigator: Mohammad F Maulana, MD, Faculty of Medicine Universitas Padjadjaran Bandung
Study Director: Suwarman, MD, Faculty of Medicine Universitas Padjadjaran Bandung
Study Director: Osmond M Pison, MD, Faculty of Medicine Universitas Padjadjaran Bandung
Study Director: Prapanca Nugraha, MD, Faculty of Medicine Universitas Padjadjaran Bandung

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitas Padjadjaran

ClinicalTrials.gov Identifier:

NCT06089200

Other Study ID Numbers:

AN-202310.01

First Posted:

Oct 18, 2023

Last Update Posted:

Oct 18, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Morphine

Study Results

No Results Posted as of Oct 18, 2023