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

Sponsor

Saint Thomas Hospital, Panama (Other)

Overall Status

Recruiting

CT.gov ID

NCT05404490

Collaborator

(none)

202

Enrollment

Location

Arms

Anticipated Duration (Months)

33.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Bupivacain Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Single-Blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Post operative pain [72 hours]
Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)

Secondary Outcome Measures

Need for rescue medication [72 hours]
Number of participants that required an additional analgesic for pain control

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Thomas H	Panama		Panama

Sponsors and Collaborators

Saint Thomas Hospital, Panama

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Osvaldo A. Reyes T., Chair of the Research Department, Saint Thomas Hospital, Panama

ClinicalTrials.gov Identifier:

NCT05404490

Other Study ID Numbers:

2020-575

First Posted:

Jun 3, 2022

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Osvaldo A. Reyes T., Chair of the Research Department, Saint Thomas Hospital, Panama

Cesarean section

Postoperative Pain

Bupivacain

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Jun 7, 2022