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

Rectal Cancer Clinical Trial

— TAP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02591407
• Other study ID #: HSR 15-1618
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2018

Study information

• Verified date: May 2017
• Source: Saint Joseph Mercy Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 185
• Est. completion date: October 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Diverticulosis
• Diverticulosis, Colonic
• Diverticulum
• Rectal Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Saint Joseph Mercy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient use of supplemental narcotic analgesia post-operative day 1	Measured in morphine equivalents	Post-operative day 1
Other	Patient use of supplemental narcotic analgesia post-operative day 2	Measured in morphine equivalents	Post-operative day 2
Other	Patient use of supplemental narcotic analgesia post-operative day 3	Measured in morphine equivalents	Post-operative day 3
Primary	Post-operative pain control day 1 using the numeric pain scale	Measured by patient using the numeric pain scale	Post-operative day 1
Primary	Post-operative pain control day 2 using the numeric pain scale	Measured by patient using the numeric pain scale	Post-operative day 2
Primary	Post-operative pain control day 3 using the numeric pain scale	Measured by patient using the numeric pain scale	Post-operative day 3
Secondary	Overall benefits of analgesia treatment post-operative day 1	Measured by patient completing the Overall Benefits of Analgesia Score survey	Post-operative day 1
Secondary	Overall benefits of analgesia treatment post-operative day 2	Measured by patient completing the Overall Benefits of Analgesia Score survey	Post-operative day 2
Secondary	Overall benefits of analgesia treatment post-operative day 3	Measured by patient completing the Overall Benefits of Analgesia Score survey	Post-operative day 3

External Links

•   American Society of Colon and Rectal Surgeons