- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03702621
Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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. |
20 mL liposomal bupivacaine are injected into the liposomal bupivacaine group
|
Active Comparator: 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. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Pain scores will be measured 1 hour after surgery
|
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
|
Pain scores will be measured 1 hour after surgery
|
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
|
Pain scores will be measured 24 hours after surgery
|
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
|
Pain scores will be measured 24 hours after surgery
|
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
|
Pain scores will be measured 48 hours after surgery
|
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
|
Pain scores will be measured 48 hours after surgery
|
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
|
Pain scores will be measured 72 hours after surgery
|
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
|
Pain scores will be measured 72 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Opioid Consumption at 1 Hour
Time Frame: Opioid consumption will be measured at 1 hour post op. The total amount will be recorded
|
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
Time Frame: Opioid consumption will be measured at 24 hour post op. The total amount will be recorded
|
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
Time Frame: Opioid consumption will be measured at 48 hour post op. The total amount will be recorded
|
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
Time Frame: Opioid consumption will be measured at 72 hour post op. The total amount will be recorded
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nausea Scores (None) at 1 Hour
Time Frame: Nausea scores will be measured at 1 hour post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 1 hour post-op.
|
Nausea Scores (Mild) at 1 Hour
Time Frame: Nausea scores will be measured at 1 hour post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 1 hour post-op.
|
Nausea Scores (Moderate) at 1 Hour
Time Frame: Nausea scores will be measured at 1 hour post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 1 hour post-op.
|
Nausea Scores (Severe) at 1 Hour
Time Frame: Nausea scores will be measured at 1 hour post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 1 hour post-op.
|
Nausea Scores (None) at 24 Hours
Time Frame: Nausea scores will be measured at 24 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 24 hours post-op.
|
Nausea Scores (Mild) at 24 Hours
Time Frame: Nausea scores will be measured at 24 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 24 hours post-op.
|
Nausea Scores (Moderate) at 24 Hours
Time Frame: Nausea scores will be measured at 24 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 24 hours post-op.
|
Nausea Scores (Severe) at 24 Hours
Time Frame: Nausea scores will be measured at 24 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 24 hours post-op.
|
Nausea Scores (None) at 48 Hours
Time Frame: Nausea scores will be measured at 48 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 48 hours post-op.
|
Nausea Scores (Mild) at 48 Hours
Time Frame: Nausea scores will be measured at 48 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 48 hours post-op.
|
Nausea Scores (Moderate) at 48 Hours
Time Frame: Nausea scores will be measured at 48 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 48 hours post-op.
|
Nausea Scores (Severe) at 48 Hours
Time Frame: Nausea scores will be measured at 48 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 48 hours post-op.
|
Nausea Scores (None) at 72 Hours
Time Frame: Nausea scores will be measured at 72 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 72 hours post-op.
|
Nausea Scores (Mild) at 72 Hours
Time Frame: Nausea scores will be measured at 72 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 72 hours post-op.
|
Nausea Scores (Moderate) at 72 Hours
Time Frame: Nausea scores will be measured at 72 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 72 hours post-op.
|
Nausea Scores (Severe) at 72 Hours
Time Frame: Nausea scores will be measured at 72 hours post-op.
|
Nausea scores will be collected by a study team member post operatively up to 3 days per protocol.
Nausea will be recorded as none, mild, moderate, or severe
|
Nausea scores will be measured at 72 hours post-op.
|
Sedation Scores (Awake/Alert) at 1 Hour
Time Frame: Sedation scores will be documented at 1 hour post-op.
|
Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements.
Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
|
Sedation scores will be documented at 1 hour post-op.
|
Sedation Scores (Quietly Awake) at 1 Hour
Time Frame: Sedation scores will be documented at 1 hour post-op.
|
Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements.
Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
|
Sedation scores will be documented at 1 hour post-op.
|
Sedation Scores (Asleep/Arousable) at 1 Hour
Time Frame: Sedation scores will be documented at 1 hour post-op.
|
Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements.
Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
|
Sedation scores will be documented at 1 hour post-op.
|
Sedation Scores (Deep Sleep) at 1 Hour
Time Frame: Sedation scores will be documented at 1 hour post-op.
|
Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements.
Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
|
Sedation scores will be documented at 1 hour post-op.
|
Sedation Scores (Awake/Alert) at 24 Hours
Time Frame: Sedation scores will be documented at 24 hours post-op.
|
Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements.
Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
|
Sedation scores will be documented at 24 hours post-op.
|
Sedation Scores (Awake/Alert) at 48 Hours
Time Frame: Sedation scores will be documented at 48 hours post-op.
|
Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements.
Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
|
Sedation scores will be documented at 48 hours post-op.
|
Sedation Scores (Awake/Alert) at 72 Hours
Time Frame: Sedation scores will be documented at 72 hours post-op.
|
Sedation scores will be collected by a study team member post operatively up to 3 days per protocol requirements.
Determining if patient is awake, alert, quietly awake, asleep and arousable, or deep sleep.
|
Sedation scores will be documented at 72 hours post-op.
|
Surgery Duration
Time Frame: Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours)
|
Duration of surgery will be collected per MR of surgeon documentation.
|
Duration of Surgery from surgery start time to surgery stop time (usually within 6 hours)
|
Length of Stay
Time Frame: Time Frame for Admission to Discharge (usually within 3-7 days)
|
Admission date until Admission Discharge
|
Time Frame for Admission to Discharge (usually within 3-7 days)
|
Time to Flatus
Time Frame: End of Surgery until first reported Flatus (usually within 3 to 5 days)
|
Hours for End of Surgery to first reported hour of Flatus
|
End of Surgery until first reported Flatus (usually within 3 to 5 days)
|
Time to Bowel Movement
Time Frame: End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days)
|
Hours for End of Surgery to first reported hour of bowel movement
|
End of Surgery until first reported Bowel movement per MR or patient reported (usually 3 to 5 days)
|
Time to Per Os
Time Frame: Time from end of surgery to time of Os (usually 4-16 hours)
|
Reported time after surgery to time of Os per MR or patient
|
Time from end of surgery to time of Os (usually 4-16 hours)
|
Ambulatory Postoperatively
Time Frame: End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop)
|
Number of patients who ambulated within 24 hours of end of surgery
|
End of Surgery until first reported ambulated postoperatively per MR or patient reported (Usually within 24 hours postop)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yar Yeap, MD, Indiana University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1806187876
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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