NCT06089200

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 12, 2023

Last Update Submit

October 12, 2023

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (2)

  • Length of time the patient needed the first additional opioid analgesics

    24 hours post operative

  • Total need for additional opioids

    24 hours post operative

Study Arms (2)

Transversus Abdominis Plane Block

EXPERIMENTAL

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

Spinal Morphine

ACTIVE COMPARATOR

Twenty two subjects were given additional morphine 100 µg intrathecally

Procedure: Spinal Morphine

Interventions

Transversus Abdominal Plane BlockPROCEDURE

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

Transversus Abdominis Plane Block
Spinal MorphinePROCEDURE

100 µg was administered intrathecally preoperatively

Spinal Morphine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Allergy history
  • Spinal converted to general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mohammad F Maulana, MD

    Faculty of Medicine Universitas Padjadjaran Bandung

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 18, 2023

Study Start

February 23, 2023

Primary Completion

April 28, 2023

Study Completion

April 28, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

ID(1)