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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404490
• Other study ID #: 2020-575
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2022
• Source: Saint Thomas Hospital, Panama
• Contact: Pamela Bárcenas, MD
• Phone: +50767811421
• Email: pamelabarc21[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: November 30, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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
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.

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for rescue medication	Number of participants that required an additional analgesic for pain control	72 hours