Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a colorectal surgery

Detailed Description
-----------------
Quadratus lumborum (QL) blocks will be done intraoperatively after induction. All procedures will be placed under the supervision of the attending anesthesiologist on the acute pain service. All patients will receive 1 gm acetaminophen and 600 mg gabapentin preoperatively. Patients above 70yo will receive 300mg gabapentin. Patient will be randomized to one of the two arms. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. For the liposomal bupivacaine (LB) group, 0.125% bupivacaine 20ml plus Exparel®10ml will then be injected into the fascial plane on each side. For the standard bupivacaine (SB) group. 30ml 0.25% bupivacaine will be injected on each side. Saline will be used for hydro-dissection until the QL block target is confirmed on ultrasound. As part of the enhanced recovery after surgery (ERAS) protocol, all patients will receive ketamine and lidocaine drip during surgery, which is the investigator's current standard of practice. All patients will be scheduled on PO acetaminophen and PO gabapentin daily postoperatively per ERAS protocol. PO oxycodone as needed (PRN) will be started once patients tolerate diet. PRN IV dilaudid may be given for severe breakthrough pain. Opioid usage at 1, 24, 48 and 72 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement (knee flexion) will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24, 48 and 72 hours after the QL block and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.

Official Title
-----------------
Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery

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

Intervention / Treatment
-----------------
* Drug: liposomal Bupivacaine
* Drug: Bupivacaine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients undergoing colorectal surgery at Indiana University Hospital American Society of Anesthesiologists (ASA) class 1, 2, 3 or 4 Age 18 or older, male or female Desires Regional anesthesia for postoperative pain control Exclusion criteria: Any contraindication for QL block. History of substance abuse in the past 6 months. Patients on more than 30mg morphine equivalents of opioids daily. Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine). Postoperative intubation. Any BMI greater than 40.0.

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
Interventional Model Description: LB group (Liposomal Bupivacaine) SB group (Standard Bupivacaine)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal Bupivacaine<br>LB (Liposomal Bupivacaine) group - This group will be receiving 20 mL EXPAREL (266mg) and 40 mL of 0.125% bupivacaine in total, 30ml on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. | Drug: liposomal Bupivacaine<br>* 20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group<br>|
| Active Comparator: Standard Bupivacaine<br>SB (Standard Bupivacaine) group - This group will be receiving 60 mL of 0.25% bupivacaine in total, 30 mL on each side. For the QL block, Shamrock sign consistent of the quadratus lumborum muscle, psoas major muscle, erector spinae muscles and the L4 transverse process will be identified. Under ultrasound guidance with an in-plane technique, the needle will be advanced into the fascial plane between the quadratus lumborum and psoas major muscles. Local anesthetic will be injected into the plane. | Drug: Bupivacaine Hydrochloride<br>* 40 mL of 0.125% bupivacaine hydrochloride are injected into the liposomal bupivacaine group. 60mL of 0.25% bupivacaine hydrochloride are injected into the standard bupivacaine group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Score at 1 Hour at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 1 hour after surgery | 
| VAS Score at 1 Hour With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 1 hour after surgery | 
| VAS Score at 24 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 24 hours after surgery | 
| VAS Score at 24 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 24 hours after surgery | 
| VAS Score at 48 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 48 hours after surgery | 
| VAS Score at 48 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 48 hours after surgery | 
| VAS Score at 72 Hours at Rest | The VAS score at rest will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 72 hours after surgery | 
| VAS Score at 72 Hours With Movement | The VAS score with movement (knee flexion) will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 1-10 for documentation with 10 being the worst pain and 0 being no pain | Pain scores will be measured 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid Consumption at 1 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Opioid consumption will be measured at 1 hour post op. The total amount will be recorded | 
| Total Opioid Consumption at 24 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Opioid consumption will be measured at 24 hour post op. The total amount will be recorded | 
| Total Opioid Consumption at 48 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Opioid consumption will be measured at 48 hour post op. The total amount will be recorded | 
| Total Opioid Consumption at 72 Hour | Opioid consumption will be collected by a study team member post operatively for 3 days per protocol time requirements | Opioid consumption will be measured at 72 hour post op. The total amount will be recorded |