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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-12

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colon Cancer Rectal Cancer Colonic Diverticulosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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TAP Block- Exparel

Transversus abdominis plane block utilizing the medication Exparel®

Group Type ACTIVE_COMPARATOR

TAP Block

Intervention Type PROCEDURE

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

Continuous Epidural Analgesia

Group Type ACTIVE_COMPARATOR

Continuous Epidural Analgesia

Intervention Type PROCEDURE

Epidural catheter placed prior to the operation in the standard fashion

Interventions

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TAP Block

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

Intervention Type PROCEDURE

Continuous Epidural Analgesia

Epidural catheter placed prior to the operation in the standard fashion

Intervention Type PROCEDURE

Other Intervention Names

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Exparel

Eligibility Criteria

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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 International Normalized Ratio (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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No