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The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
TAP Block
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients over the age of 18 years w
  2. Elective laparoscopic colorectal resection.

Exclusion Criteria:

  1. Patients under 18 years.
  2. Patients unable to provide informed consent
  3. Patients undergoing emergency surgery.
  4. Pregnant women
  5. Severe liver or kidney disease (GFR 15-29 ml/min)

Sites / Locations

  • Spectrum Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAP Block Experal

No TAP Block

Arm Description

Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.

Outcomes

Primary Outcome Measures

Postoperative Pain Score
Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.

Secondary Outcome Measures

Postoperative Narcotic Use
Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.

Full Information

First Posted
December 2, 2013
Last Updated
January 31, 2023
Sponsor
Spectrum Health Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02263963
Brief Title
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.
Official Title
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP Block Experal
Arm Type
Experimental
Arm Description
Patient who randomized to this arm, will be blinded, TAP block will be performed under ultrasound guidance, where 20-30 ml of Exparel will be injected in transversus abdominis plane, bilaterally.
Arm Title
No TAP Block
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Description
In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
Intervention Type
Procedure
Intervention Name(s)
TAP Block
Intervention Description
no intervention will be done to this arm.
Primary Outcome Measure Information:
Title
Postoperative Pain Score
Description
Patient will be evaluate for their post operative pain by nurses using visual analog scale from 0 to 10, zero means no pain, 10 is the worst pain can patient ever experience.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary Outcome Measure Information:
Title
Postoperative Narcotic Use
Description
Will be measured, by converting all narcotic medicine used during postoperative period to equal morphine in mg, a calculator created by our pharmacy expert is able to convert any narcotic medicine such as fentanyl, oxycodone, hydromorphone, to morphine in mg. By doing that will have one variable to compare to the two groups.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Other Pre-specified Outcome Measures:
Title
Postoperative Complications.
Description
Any postoperative complications within 30 days of procedure, including death will be recorded.
Time Frame
participants will be followed for the duration of hospital stay, and 30 days after discharge.
Title
Length of Hospital Stay.
Description
Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 years w Elective laparoscopic colorectal resection. Exclusion Criteria: Patients under 18 years. Patients unable to provide informed consent Patients undergoing emergency surgery. Pregnant women Severe liver or kidney disease (GFR 15-29 ml/min)
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

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