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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Colon Cancer, Rectal Cancer, Colonic Diverticulosis

Intervention / Treatment
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* Procedure: TAP Block
* Procedure: Continuous Epidural Analgesia


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain control day 1 using the numeric pain scale | Measured by patient using the numeric pain scale | Post-operative day 1 | 
| Post-operative pain control day 2 using the numeric pain scale | Measured by patient using the numeric pain scale | Post-operative day 2 | 
| Post-operative pain control day 3 using the numeric pain scale | Measured by patient using the numeric pain scale | Post-operative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall benefits of analgesia treatment post-operative day 1 | Measured by patient completing the Overall Benefits of Analgesia Score survey | Post-operative day 1 | 
| Overall benefits of analgesia treatment post-operative day 2 | Measured by patient completing the Overall Benefits of Analgesia Score survey | Post-operative day 2 | 
| Overall benefits of analgesia treatment post-operative day 3 | Measured by patient completing the Overall Benefits of Analgesia Score survey | Post-operative day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Epidural Analgesia, Transversus Abdominis Plane block