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

Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section. Randomized, Single Blind, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Bupivacain; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Panama
  • Provincia de Panamá
    • Panama City, Provincia de Panamá, Panama
      • Saint Thomas H

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• Any patient who does not meet the inclusion criteria.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for rescue medication	Number of participants that required an additional analgesic for pain control	72 hours

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 23, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative Pain; Cesarean section; Bupivacain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Substandard Drugs; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine; Counterfeit Drugs
• Other Study ID Numbers: 2020-575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No