Expired Study
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Ann Arbor, Michigan 48106


Purpose:

The primary outcome for this study is the Numeric Pain Score (NPS) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.


Study summary:

Adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. There are many options for the peri-operative management of pain after elective colorectal surgery. This is a randomized clinical trial comparing the transversus abdominis plane block using Exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.


Criteria:

Inclusion Criteria: - Patients undergoing elective open and minimally invasive (laparoscopic and robotic) colon and rectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectum; - Surgical procedure either through standard open or minimal invasive approach (laparoscopic or robotic); - Patients > 18 years of age; - Able to provide informed written consent - Patients capable of completing questionnaires at the time of consent Exclusion Criteria: - Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl; - Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated INR, anticoagulation, patient refusal, etc) or TAP block (patient refusal); - Urgent or emergent surgery precluding epidural catheter placement or TAP block; - Systemic Infection contraindicating epidural catheter placement or TAP block; - Unwillingness to participate in follow up assessments; - Prisoners - Pregnant women


Study is Available At:


Original ID:

HSR 15-1618


NCT ID:

NCT02591407


Secondary ID:


Study Acronym:

TAP


Brief Title:

Trial Comparing Transversus Abdominis Plane Block Versus Epidural Anesthesia for Pain Management in Colorectal Surgery


Official Title:

A Prospective Randomized Clinical Trial Comparing the Transversus Abdominis Plane Block (TAP) Versus Epidural Anesthesia For Enhanced Recovery Pathway Perioperative Management of Pain in Elective Colorectal Surgery


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Saint Joseph Mercy Health System


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

185


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert K Cleary, MD
Principal Investigator
Saint Joseph Mercy Hospital

Study Dates

Start Date:January 2016
Completion Date:October 2018
Completion Type:Anticipated
Primary Completion Date:July 2018
Primary Completion Type:Anticipated
Verification Date:May 2017
Last Changed Date:May 15, 2018
First Received Date:October 7, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Overall benefits of analgesia treatment post-operative day 3
Time Frame:Post-operative day 3
Safety Issues:False
Description:Measured by patient completing the Overall Benefits of Analgesia Score survey
Outcome Type:Secondary Outcome
Measure:Overall benefits of analgesia treatment post-operative day 2
Time Frame:Post-operative day 2
Safety Issues:False
Description:Measured by patient completing the Overall Benefits of Analgesia Score survey
Outcome Type:Secondary Outcome
Measure:Overall benefits of analgesia treatment post-operative day 1
Time Frame:Post-operative day 1
Safety Issues:False
Description:Measured by patient completing the Overall Benefits of Analgesia Score survey
Outcome Type:Primary Outcome
Measure:Post-operative pain control day 3 using the numeric pain scale
Time Frame:Post-operative day 3
Safety Issues:False
Description:Measured by patient using the numeric pain scale
Outcome Type:Primary Outcome
Measure:Post-operative pain control day 2 using the numeric pain scale
Time Frame:Post-operative day 2
Safety Issues:False
Description:Measured by patient using the numeric pain scale
Outcome Type:Primary Outcome
Measure:Post-operative pain control day 1 using the numeric pain scale
Time Frame:Post-operative day 1
Safety Issues:False
Description:Measured by patient using the numeric pain scale

Study Interventions

Intervention Type:Procedure
Name:TAP Block
Description:This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
Arm Name:TAP Block- Exparel
Other Name:Exparel
Intervention Type:Procedure
Name:Continuous Epidural Analgesia
Description:Epidural catheter placed prior to the operation in the standard fashion
Arm Name:Continuous Epidural Analgesia

Study Arms

Study Arm Type:Active Comparator
Arm Name:Continuous Epidural Analgesia
Description:Continuous Epidural Analgesia
Study Arm Type:Active Comparator
Arm Name:TAP Block- Exparel
Description:Transversus abdominis plane block utilizing the medication Exparel®

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Saint Joseph Mercy Health System

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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