Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- VAS Score at 1 Hour at Rest
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Both the patients and the research staff doing assessments will be blinded to the randomization.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Liposomal Bupivacaine
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.
Intervention: liposomal Bupivacaine (Drug)
Standard Bupivacaine
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.
Intervention: Bupivacaine Hydrochloride (Drug)
Outcomes
Primary Outcomes
VAS Score at 1 Hour at Rest
Time Frame: Pain scores will be measured 1 hour after surgery
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
VAS Score at 1 Hour With Movement
Time Frame: Pain scores will be measured 1 hour after surgery
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
VAS Score at 24 Hours at Rest
Time Frame: Pain scores will be measured 24 hours after surgery
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
VAS Score at 24 Hours With Movement
Time Frame: Pain scores will be measured 24 hours after surgery
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
VAS Score at 48 Hours at Rest
Time Frame: Pain scores will be measured 48 hours after surgery
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
VAS Score at 48 Hours With Movement
Time Frame: Pain scores will be measured 48 hours after surgery
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
VAS Score at 72 Hours at Rest
Time Frame: Pain scores will be measured 72 hours after surgery
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
VAS Score at 72 Hours With Movement
Time Frame: Pain scores will be measured 72 hours after surgery
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
Secondary Outcomes
- Total Opioid Consumption at 24 Hour(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 measured at 48 hour post op. The total amount will be recorded)
- Total Opioid Consumption at 1 Hour(Opioid consumption will be measured at 1 hour post op. The total amount will be recorded)
- Total Opioid Consumption at 72 Hour(Opioid consumption will be measured at 72 hour post op. The total amount will be recorded)
Investigators
Yar Yeap
Director, Acute Pain Service Assistant Professor of Clinical Anesthesiology Indiana University School of Medicine Department of Anesthesiology
Indiana University