- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02263963
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.
January 31, 2023 updated by: Spectrum Health Hospitals
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAP Block Experal
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.
|
In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
no intervention will be done to this arm.
|
No Intervention: No TAP Block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Pain Score
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
|
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.
|
participants will be followed for the duration of hospital stay, an expected average of 4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Narcotic Use
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
|
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.
|
participants will be followed for the duration of hospital stay, an expected average of 4 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Complications.
Time Frame: participants will be followed for the duration of hospital stay, and 30 days after discharge.
|
Any postoperative complications within 30 days of procedure, including death will be recorded.
|
participants will be followed for the duration of hospital stay, and 30 days after discharge.
|
Length of Hospital Stay.
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
|
Length of hospital stay will be measured in number of days patient spends in the hospital from the day of procedure till discharge.
|
participants will be followed for the duration of hospital stay, an expected average of 4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
December 2, 2013
First Submitted That Met QC Criteria
October 13, 2014
First Posted (Estimate)
October 15, 2014
Study Record Updates
Last Update Posted (Estimate)
February 28, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-066
- DDI.FY13.07 (Other Identifier: Digestive Disease Institute/Ferguson Clinic)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Exparel
-
Pacira Pharmaceuticals, IncCompletedPostoperative Pain ManagementUnited States
-
Pacira Pharmaceuticals, IncTerminatedPostoperative Pain ManagementUnited States
-
Texas Tech University Health Sciences CenterNot yet recruiting
-
Pacira Pharmaceuticals, IncCompleted
-
Rothman Institute OrthopaedicsCompletedOsteoarthritis: Joint Replacement Surgery
-
OrthoCarolina Research Institute, Inc.Pacira Pharmaceuticals, IncCompletedAnkle Arthrodesis | Hindfoot Arthrodesis | Tibitalocalceal ArthrodesisUnited States
-
Mayo ClinicSusan G. Komen Breast Cancer FoundationCompleted
-
Pacira Pharmaceuticals, IncCompletedPain Management | Spinal FusionUnited States
-
Children's Hospital of Orange CountyRecruitingPain | Anxiety | ACL Tear | Opioid MisuseUnited States