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TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics

Primary Purpose

Post Operative Pain

Status

Completed

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

Transversus Abdominal Plane Block

Spinal Morphine

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Hasan Sadikin General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transversus Abdominis Plane Block

Spinal Morphine

Arm Description

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

Twenty two subjects were given additional morphine 100 µg intrathecally

Outcomes

Primary Outcome Measures

Length of time the patient needed the first additional opioid analgesics

Total need for additional opioids

Secondary Outcome Measures

Full Information

NCT ID

NCT06089200

First Posted

October 12, 2023

Last Updated

October 12, 2023

Sponsor

Universitas Padjadjaran

1. Study Identification

Unique Protocol Identification Number

NCT06089200

Brief Title

TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

February 23, 2023 (Actual)

Primary Completion Date

April 28, 2023 (Actual)

Study Completion Date

April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitas Padjadjaran

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transversus Abdominis Plane Block

Arm Type

Experimental

Arm Description

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

Arm Title

Spinal Morphine

Arm Type

Active Comparator

Arm Description

Twenty two subjects were given additional morphine 100 µg intrathecally

Intervention Type

Procedure

Intervention Name(s)

Transversus Abdominal Plane Block

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Spinal Morphine

Intervention Description

100 µg was administered intrathecally preoperatively

Primary Outcome Measure Information:

Title

Length of time the patient needed the first additional opioid analgesics

Time Frame

24 hours post operative

Title

Total need for additional opioids

Time Frame

24 hours post operative

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad F Maulana, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran Bandung

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suwarman, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran Bandung

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Osmond M Pison, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran Bandung

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Prapanca Nugraha, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran Bandung

Official's Role

Study Director

Facility Information:

Facility Name

Hasan Sadikin General Hospital

City

Bandung

State/Province

Jawa Barat

ZIP/Postal Code

40161

Country

Indonesia

12. IPD Sharing Statement

Learn more about this trial

TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics

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