Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
This study is prospective, randomized trial in which EXPAREL TAP block is compared to standard IT opioid administration, in relieving postoperative pain, decreasing length of stay, and use of narcotic medication.

Detailed Description
-----------------
Primary Objective To assess efficacy of EXPAREL TAP blocks in improving pain scores for 48 hours postoperatively, and in reducing total oral morphine equivalents (OME) use, compared to standard Intrathecal opioid administration (IT). Secondary Objective Assess the length of stay (LOS), postoperative ileus (POI) incidence, and the use of intravenous patient controlled analgesia (PCA) in patients that had EXPAREL TAP blocs compared to IT.

Official Title
-----------------
Exparel Transversus Abdominis Plane Block vs Intrathecal Analgesia In Colorectal Surgery: A Prospective Randomized Trial

Conditions
-----------------
Conditions Requiring Colorectal Surgery

Intervention / Treatment
-----------------
* Drug: EXPAREL
* Drug: Intrathecal hydromorphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All patients undergoing elective laparoscopic or open colorectal resections who are eligible for IT Age >18 years BMI <40 Ability to understand and read English Exclusion Criteria: • Not able or unwilling to sign consent. Currently pregnant or lactating. Patients with chronic pain, requiring daily opiate use at time of surgery. Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics. Patients requiring emergent surgery. Abdominoperineal resections Any contraindications to neuraxial analgesia (coagulopathy, localized infection at the potential site of injection, pre-existing spinal canal pathology) Patients with a diagnosis of inflammatory bowel disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP block (EXPAREL)<br>After induction of anesthesia, the patients will receive a single injection with 133 mg of EXPAREL in the transversus abdominis plane (TAP), on each side, suspended in 20 milliliters (mL) of injectable saline. | Drug: EXPAREL<br>* transversus abdominis plane injection<br>* Other names: liposomal bupivacaine;|
| Active Comparator: Intrathecal opioid (IT)<br>single injection intrathecal hydromorphone analgesia given preoperatively | Drug: Intrathecal hydromorphone<br>* Intrathecal opioid administration<br>* Other names: dilaudid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain Score | Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation. | First 48 hours post operative | 
| Total Morphine Milligram Equivalents Use (MME) | The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies. | First 48 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Length of Hospital Stay | Length of stay was defined as the total number of nights spent in the hospital after surgery. | post-operative to discharge | 
| Number of Participants With Post-operative Ileus | Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery. | 24 hours post-operatively | 
| Use of Intravenous Patient-controlled Analgesia | The total number of patients that used patient-controlled analgesia within 48 hours after surgery. | First 48 hours post-operative |