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

Not Applicable

• Conditions: Colon Cancer; Colonic Diverticulosis; Rectal Cancer
• Interventions: Procedure: TAP Block; Procedure: Continuous Epidural Analgesia

• Registration Number: NCT02591407
• Lead Sponsor: Saint Joseph Mercy Health System

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.

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 Timeline

• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Study Start: 2016-01
• Status Verified: 2017-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-17
• Primary Completion: 2018-07
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 185

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block- Exparel	TAP Block	Transversus abdominis plane block utilizing the medication Exparel®
Continuous Epidural Analgesia	Continuous Epidural Analgesia	Continuous Epidural Analgesia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Saint Joseph Mercy Hospital; 🇺🇸 Ann Arbor, Michigan, United States