TAP Block vs Spinal Orphine for Postoperative Caesarean Section Analgetics

NCT ID: NCT06089200

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-04-28

Brief Summary

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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

Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Transversus Abdominis Plane Block

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

Group Type EXPERIMENTAL

Transversus Abdominal Plane Block

Intervention Type PROCEDURE

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

Spinal Morphine

Twenty two subjects were given additional morphine 100 µg intrathecally

Group Type ACTIVE_COMPARATOR

Spinal Morphine

Intervention Type PROCEDURE

100 µg was administered intrathecally preoperatively

Interventions

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Transversus Abdominal Plane Block

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

Intervention Type PROCEDURE

Spinal Morphine

100 µg was administered intrathecally preoperatively

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitas Padjadjaran

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad F Maulana, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Universitas Padjadjaran Bandung

Suwarman, MD

Role: STUDY_DIRECTOR

Faculty of Medicine Universitas Padjadjaran Bandung

Osmond M Pison, MD

Role: STUDY_DIRECTOR

Faculty of Medicine Universitas Padjadjaran Bandung

Prapanca Nugraha, MD

Role: STUDY_DIRECTOR

Faculty of Medicine Universitas Padjadjaran Bandung

Locations

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Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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AN-202310.01

Identifier Type: -

Identifier Source: org_study_id

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