Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section

NCT ID: NCT05404490

Last Updated: 2025-08-26

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

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single-Blind

Study Groups

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Bupivacaine

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.

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

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.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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Bupivacain

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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Chair of the Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint Thomas H

Panama City, Provincia de Panamá, Panama

Site Status

Countries

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Panama

Other Identifiers

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2020-575

Identifier Type: -

Identifier Source: org_study_id

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