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Completed

NCT Number: NCT05404490

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain

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

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.

Primary outcomes

  1. Post operative pain

    Time frame: 72 hours

    Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)

Secondary outcomes

  1. Need for rescue medication

    Time frame: 72 hours

    Number of participants that required an additional analgesic for pain control

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2022
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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