Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section
1 other identifier
interventional
202
1 country
1
Brief Summary
This study aims to evaluate the effect of local administration of bupivacain in the cesarean section incision for postoperative pain control, using the visual analogue pain scale (VAS) and assessing the need for rescue analgesia after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 31, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedAugust 26, 2025
August 1, 2025
5 months
May 31, 2022
August 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative pain
Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)
72 hours
Secondary Outcomes (1)
Need for rescue medication
72 hours
Study Arms (2)
Bupivacaine
EXPERIMENTAL20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
Placebo
PLACEBO COMPARATOR20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
Interventions
20 mL of bupivacaine 0.5% will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
20 mL of Normal Saline Solution will be infiltrated. 10 mL will be infiltrated in the inferior border and 10 mL in the superior border of the subcutaneous cellular tissue.
Eligibility Criteria
You may qualify if:
- Gestational age ≥ 36 weeks
- Elective cesarean section
- Transverse segmental caesarean section Pfannenstiel type
- Spinal anesthesia
- Maternal age 18 to 45 years
- Any gravaparity
- Patient ASA I or II
You may not qualify if:
- Emergency cesarean section
- History of chronic or neuropathic pain
- Patient with cardiopulmonary disease
- Known allergies to the drugs used in the study
- Patient who does not wish to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Thomas H
Panama City, Provincia de Panamá, Panama
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of the Research Department
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 3, 2022
Study Start
June 1, 2022
Primary Completion
October 31, 2022
Study Completion
November 30, 2022
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share