Clinical trial NCT02591407: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Colonic Diverticulosis
Keywords: Continuous Epidural Analgesia
Transversus Abdominis Plane block
Lead sponsor: Saint Joseph Mercy Health System
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Post-operative pain control day 1 using the numeric pain scale
timeFrame: Post-operative day 1
measure: Post-operative pain control day 2 using the numeric pain scale
timeFrame: Post-operative day 2
measure: Post-operative pain control day 3 using the numeric pain scale
timeFrame: Post-operative day 3
Secondary outcomes:
measure: Overall benefits of analgesia treatment post-operative day 1
timeFrame: Post-operative day 1
measure: Overall benefits of analgesia treatment post-operative day 2
timeFrame: Post-operative day 2
measure: Overall benefits of analgesia treatment post-operative day 3
timeFrame: Post-operative day 3
Other outcomes:
measure: Patient use of supplemental narcotic analgesia post-operative day 1
timeFrame: Post-operative day 1
measure: Patient use of supplemental narcotic analgesia post-operative day 2
timeFrame: Post-operative day 2
measure: Patient use of supplemental narcotic analgesia post-operative day 3
timeFrame: Post-operative day 3
Locations:
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
Study officials:
affiliation: Saint Joseph Mercy Hospital
name: Robert K Cleary, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.