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

Sponsor

Saint Joseph Mercy Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT02591407

Collaborator

(none)

185

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Rectal Cancer Colonic Diverticulosis	Procedure: TAP Block Procedure: Continuous Epidural Analgesia	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TAP Block- Exparel Transversus abdominis plane block utilizing the medication Exparel®	Procedure: TAP Block This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles Other Names: Exparel
Active Comparator: Continuous Epidural Analgesia Continuous Epidural Analgesia	Procedure: Continuous Epidural Analgesia Epidural catheter placed prior to the operation in the standard fashion

Arm

Intervention/Treatment

Active Comparator: TAP Block- Exparel

Transversus abdominis plane block utilizing the medication Exparel®

Procedure: TAP Block

This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles

Other Names:

Exparel

Active Comparator: Continuous Epidural Analgesia

Continuous Epidural Analgesia

Procedure: Continuous Epidural Analgesia

Epidural catheter placed prior to the operation in the standard fashion

Outcome Measures

Primary Outcome Measures

Post-operative pain control day 1 using the numeric pain scale [Post-operative day 1]
Measured by patient using the numeric pain scale
Post-operative pain control day 2 using the numeric pain scale [Post-operative day 2]
Measured by patient using the numeric pain scale
Post-operative pain control day 3 using the numeric pain scale [Post-operative day 3]
Measured by patient using the numeric pain scale

Secondary Outcome Measures

Overall benefits of analgesia treatment post-operative day 1 [Post-operative day 1]
Measured by patient completing the Overall Benefits of Analgesia Score survey
Overall benefits of analgesia treatment post-operative day 2 [Post-operative day 2]
Measured by patient completing the Overall Benefits of Analgesia Score survey
Overall benefits of analgesia treatment post-operative day 3 [Post-operative day 3]
Measured by patient completing the Overall Benefits of Analgesia Score survey

Other Outcome Measures

Patient use of supplemental narcotic analgesia post-operative day 1 [Post-operative day 1]
Measured in morphine equivalents
Patient use of supplemental narcotic analgesia post-operative day 2 [Post-operative day 2]
Measured in morphine equivalents
Patient use of supplemental narcotic analgesia post-operative day 3 [Post-operative day 3]
Measured in morphine equivalents

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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