Study Stopped
A better study with a better drug was started and thus this study was terminated
Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia
TAPROPI
The Dose Dependent Effect of Ropivacaine Transversus Abdominis Plane Blocks on Postoperative Analgesia After Cesarean Section
1 other identifier
interventional
51
1 country
1
Brief Summary
With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Jan 2013
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2016
CompletedResults Posted
Study results publicly available
September 21, 2022
CompletedSeptember 21, 2022
May 1, 2022
3.7 years
June 26, 2016
May 16, 2022
August 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
POSTOPERATIVE PAIN
Severity of postoperative pain will be assessed using(VAS) scale. Post-operative pain scale name: Visual Analog Scale (0-10) with 0 being no-pain and 10 being maximum pain.
48 hours
Study Arms (3)
Group 1 - 0.5% Ropivacaine
ACTIVE COMPARATORPatients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin
Group 2 - 0.25% Ropivacaine
ACTIVE COMPARATORPatients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin
Group 3 - No Tap Block
NO INTERVENTIONPatients will not receive a TAP BLOCK
Interventions
Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Eligibility Criteria
You may qualify if:
- Pregnant patients undergoing elective c-section
You may not qualify if:
- Allergy to local anesthetics
- Contraindication to tap blocks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kalpana Tyagaraj
- Organization
- Maimonides Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
KALPANA TYAGARAJ, MD
MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Residency Program Director
Study Record Dates
First Submitted
June 26, 2016
First Posted
September 8, 2016
Study Start
January 1, 2013
Primary Completion
September 30, 2016
Study Completion
September 30, 2016
Last Updated
September 21, 2022
Results First Posted
September 21, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share