Back to resultsEfficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Bupivacain
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Cesarean section, Postoperative Pain, Bupivacain
Eligibility Criteria
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
Sites / Locations
- Saint Thomas HRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bupivacaine
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Post operative pain
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
Number of participants that required an additional analgesic for pain control
Full Information
NCT ID
NCT05404490
First Posted
May 31, 2022
Last Updated
June 2, 2022
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT05404490
Brief Title
Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section
Official Title
Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section. Randomized, Single Blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Cesarean section, Postoperative Pain, Bupivacain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single-Blind
Allocation
Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
Bupivacain
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Post operative pain
Description
Level of pain described using a Visual Analogue Scale (VAS) Lower value: 0 (no pain) Higher value: 10 (worst pain possible)
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Need for rescue medication
Description
Number of participants that required an additional analgesic for pain control
Time Frame
72 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Bárcenas, MD
Phone
+50767811421
Email
pamelabarc21@gmail.com
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osvaldo A Reyes, MD
Phone
o11(507)65655041
Email
oreyespanama@yahoo.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Bupivacain Local Infiltration for the Management of Pain During Cesarean Section
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