QL Block With Exparel in Colectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.

Detailed Description
-----------------
Participants in this study will receive exparel via an abdominal muscle nerve block procedure immediately prior to their operation. Participants will be in this study for 96 hours following surgery, which is typically 3 days. During participation, the study staff will review participant's electronic health records for pain scores and pain medication needs. Participants that receive the quadratus lumborum block, may experience improved pain control and/or reduced side effects compared to the epidural pain relief option, but it is not known yet whether this will be the case. The most common risk is being sore in the flank where the block was placed. Other risks of the block rarely occur (less than .5-1%), these can include infection, allergy to the local anesthetic, bleeding, damage to the nerve, seizures, abnormal heart rhythms, and cardiac arrest.

Official Title
-----------------
Quantitative Observational Comparative Effectiveness of Quadratus Lumborum (QL) Block With Liposomal Bupivacaine (Exparel®) Versus Thoracic Epidural Analgesia in Patients Undergoing Laparoscopic Colectomy.

Conditions
-----------------
Laparotomy, Colectomy

Intervention / Treatment
-----------------
* Drug: Exparel
* Other: Thoracic epidural analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective, laparoscopic colonic resection by one of three surgeons: Drs. Thacker, Mantyh or Migaly. These surgeons perform this procedure in the same manner Age 18-85 years American Society of Anesthesiologists (ASA) Physical Class I-III BMI 18-35 kg/m^2 Exclusion Criteria: Inability to consent Inability to speak English Pregnancy Emergency surgery Contraindications to regional blockade: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics Allergies/intolerances/contraindications to any of the multimodal agents (acetaminophen, gabapentin, ketorolac) Daily opioid equivalent use of 30 mg of morphine or greater at time of consent History of drug or alcohol abuse Rheumatoid arthritis Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments of compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare efficacy of a quadratus lumborum block performed with liposomal bupivacaine for pain relief after laparoscopic colectomy compared to a historical cohort who received thoracic epidural analgesia.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadratus lumborum block<br>Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles. | Drug: Exparel<br>* Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.<br>|
| Other: Thoracic epidural analgesia<br>Historical cohort that received thoracic epidural analgesia. | Other: Thoracic epidural analgesia<br>* Historical cohort that received thoracic epidural analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative opioid consumption over 48 hours | Opioid consumption from administration of Exparel to 48 hours post-administration | Opioid consumption from administration of Exparel to 48 hours post-administration |