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Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia (TAPROPI)

Primary Purpose

Postoperative Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Ropivacaine, C-Section Analgesia, Tap Block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant patients undergoing elective c-section

Exclusion criteria:

  • Allergy to local anesthetics
  • Contraindication to tap blocks

Sites / Locations

  • Maimonides Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group 1 - 0.5% Ropivacaine

Group 2 - 0.25% Ropivacaine

Group 3 - No Tap Block

Arm Description

Patients 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

Patients 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

Patients will not receive a TAP BLOCK

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2016
Last Updated
August 27, 2022
Sponsor
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02893423
Brief Title
Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia
Acronym
TAPROPI
Official Title
The Dose Dependent Effect of Ropivacaine Transversus Abdominis Plane Blocks on Postoperative Analgesia After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
A better study with a better drug was started and thus this study was terminated
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
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). The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. The investigators will inject the local anesthetic ropivacaine into this space to freeze these nerves and prevent pain following c-section. The investigators will compare three different doses of ropivacaine (0.5%, 0.25%, 0%) to determine the lowest dose that controls pain with the fewest side effects. Participants in this study will receive 0.5% (Group 1), 0.25% (Group 2), or 0% (Group 3) ropivacaine TAP blocks to control pain after c-section. At 2, 6, 12, 24, and 48 hours after cesarean section visual analog pain scores (VAS) for pain on movement, pain at rest, and pain with cough will be collected along with the time to first postoperative analgesic request, patient satisfaction scores, and patient demographics. The analgesic regimen will be considered effective if it provides lower average visual analog scores for pain with movement. Secondary outcomes will be higher patient satisfaction, better pain control, fewer postoperative analgesic requests, and fewer side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Ropivacaine, C-Section Analgesia, Tap Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - 0.5% Ropivacaine
Arm Type
Active Comparator
Arm Description
Patients 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
Arm Title
Group 2 - 0.25% Ropivacaine
Arm Type
Active Comparator
Arm Description
Patients 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
Arm Title
Group 3 - No Tap Block
Arm Type
No Intervention
Arm Description
Patients will not receive a TAP BLOCK
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
Primary Outcome Measure Information:
Title
POSTOPERATIVE PAIN
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant patients undergoing elective c-section Exclusion criteria: Allergy to local anesthetics Contraindication to tap blocks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KALPANA TYAGARAJ, MD
Organizational Affiliation
MAIMONIDES MEDICAL CENTER, 4802, 10TH AVENUE, BROOKLYN, NY-11219
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ropivacaine Transversus Abdominis Plane Blocks for Cesarean Section Analgesia

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