Use of Exparel for Postoperative Analgesia Following Bariatric Surgery
Primary Purpose
Post Operative Pain
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Exparel 266 MG Per 20 ML Injection
Bupivacaine Hcl 0.25% Inj
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- The patient previously met NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure
- The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network
Exclusion Criteria:
- Inability to give informed consent
- ASA > 4
- Planned procedure other than Roux-en-Y gastric bypass (RYGB) or contraindications to RYGB
- BMI > 55 kg/m2
- Revisional procedure
- Allergies or suspected allergies to local anesthetic medications (bupivicaine)
- Renal insufficiency (GFR < 30ml/min)
- History of chronic pain needing daily medications for the last >3 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exparel (Liposomal Bupivicaine)
0.25% Bupivicaine HCL
Arm Description
20 ml vial of liposomal bupivacaine containing 266 mg (maximum dose), will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Two 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes and levels via laparoscopy. Medication will be given just below the last rib and extend to below the lowest incision.
Outcomes
Primary Outcome Measures
Efficacy of liposomal bupivicaine via TAP block in eliminating narcotic use post-operatively
Proportion of patients requiring narcotics post-procedure until discharge as recorded via their electronic medical record.
Secondary Outcome Measures
Analog pain scores
Pain will be assessed in the post-anaesthesia care unit (PACU) at 2 occasions - upon arrival and before transfer to ward. Subsequently, pain scores will then be reassessed at 8 am, 2 pm, and 8pm until discharge. Pain will be measured on an 11-point scale from 0 (no pain) to 10 (most pain imaginable) and the average of the PACU and ward scores will be used as the final outcomes.
Post-operative nausea
Postoperative nausea scores will be assessed daily at 8 am, 2 pm, and 8pm until discharge using an 11-point scale from 0 (no nausea) to 10 (most nausea imaginable)
Post-operative Narcotic Use
Postoperative narcotic use will be recorded in morphine equivalent units and recorded via their electronic medical record.
Hospital Length of Stay
Length of stay calculated in hours
Full Information
NCT ID
NCT03975283
First Posted
May 31, 2019
Last Updated
June 4, 2019
Sponsor
McMaster University
Collaborators
Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03975283
Brief Title
Use of Exparel for Postoperative Analgesia Following Bariatric Surgery
Official Title
Use of Long-acting Local Analgesia in Bariatrics: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Pacira Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of liposomal bupivicaine in post operative analgesia for patients undergoing bariatric surgery when compared to conventional local analgesia. Patients will be randomly selected to receive either liposomal bupivicaine or conventional bupivicaine via a transversus abdominal plane block during surgery. Patients will be followed post-operatively to assess use of narcotics, post-operative pain and nausea scores, and length of stay.
Detailed Description
Optimizing pain management following bariatric surgery is an important aspect of patient care and post-surgical recovery. Despite advances in post-operative pain management, this remains a challenge and opioids continue to dominate as the most widely used analgesia for post-surgical pain management. Opioid use especially in the opioid-naive patient carries significant short term and long term risks including over dependence and chronic opioid use.
Movements towards minimizing post-operative opioid use has shown regional anesthetic techniques to be highly effective in the management of pain in surgical patients. More specifically, liposomal bupivicaine (Exparel) is a novel non-opioid local analgesia that takes advantage of a multi-vesicular liposomal system to provide extended analgesia release over 72-96 hours.
The purpose of this study to evaluate the use of liposomal bupivicaine in the management of post-operative pain following bariatric surgery via a transversus abdominis plane (TAP) block. Patients will be randomized to receiving either liposomal bupivicaine or traditional 0.25% bupivicaine locally infiltrated at the time of bariatric surgery. Both liposomal bupivicaine and traditional bupivicaine will be administered via TAP block after identification of planes via laparoscopy by the bariatric surgeon.
Patients will be followed post-operatively to assess use of opioid analgesia between the two arms. In addition, they will be assessed with respect to pain and nausea using analog scores, as well as hospital length of stay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exparel (Liposomal Bupivicaine)
Arm Type
Experimental
Arm Description
20 ml vial of liposomal bupivacaine containing 266 mg (maximum dose), will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Arm Title
0.25% Bupivicaine HCL
Arm Type
Active Comparator
Arm Description
Two 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes and levels via laparoscopy. Medication will be given just below the last rib and extend to below the lowest incision.
Intervention Type
Drug
Intervention Name(s)
Exparel 266 MG Per 20 ML Injection
Intervention Description
266mg of liposomal bupivacaine 266 mg, 20 mL volume, will be diluted with 20 ml of 0.25% bupivacaine (50 mg of bupivacaine) and 20 ml saline, thereby totalling 60mL volume. Total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hcl 0.25% Inj
Intervention Description
0.25% bupivacaine, 60mL total, divided into two 30mL syringes and delivered via TAP block on either side.
Primary Outcome Measure Information:
Title
Efficacy of liposomal bupivicaine via TAP block in eliminating narcotic use post-operatively
Description
Proportion of patients requiring narcotics post-procedure until discharge as recorded via their electronic medical record.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Analog pain scores
Description
Pain will be assessed in the post-anaesthesia care unit (PACU) at 2 occasions - upon arrival and before transfer to ward. Subsequently, pain scores will then be reassessed at 8 am, 2 pm, and 8pm until discharge. Pain will be measured on an 11-point scale from 0 (no pain) to 10 (most pain imaginable) and the average of the PACU and ward scores will be used as the final outcomes.
Time Frame
10 days (or until discharge)
Title
Post-operative nausea
Description
Postoperative nausea scores will be assessed daily at 8 am, 2 pm, and 8pm until discharge using an 11-point scale from 0 (no nausea) to 10 (most nausea imaginable)
Time Frame
10 days (or until discharge)
Title
Post-operative Narcotic Use
Description
Postoperative narcotic use will be recorded in morphine equivalent units and recorded via their electronic medical record.
Time Frame
10 days (or until discharge)
Title
Hospital Length of Stay
Description
Length of stay calculated in hours
Time Frame
Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient previously met NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure
The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network
Exclusion Criteria:
Inability to give informed consent
ASA > 4
Planned procedure other than Roux-en-Y gastric bypass (RYGB) or contraindications to RYGB
BMI > 55 kg/m2
Revisional procedure
Allergies or suspected allergies to local anesthetic medications (bupivicaine)
Renal insufficiency (GFR < 30ml/min)
History of chronic pain needing daily medications for the last >3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Barlow
Phone
905-522-1155
Ext
33739
Email
kbarlow@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margherita Cadeddu, MD, FRCSC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data
Citations:
PubMed Identifier
24733580
Citation
Raebel MA, Newcomer SR, Bayliss EA, Boudreau D, DeBar L, Elliott TE, Ahmed AT, Pawloski PA, Fisher D, Toh S, Donahoo WT. Chronic opioid use emerging after bariatric surgery. Pharmacoepidemiol Drug Saf. 2014 Dec;23(12):1247-57. doi: 10.1002/pds.3625. Epub 2014 Apr 14.
Results Reference
background
PubMed Identifier
23049275
Citation
Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.
Results Reference
background
PubMed Identifier
22900785
Citation
Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
Results Reference
background
PubMed Identifier
23204866
Citation
Cohen SM. Extended pain relief trial utilizing infiltration of Exparel((R)), a long-acting multivesicular liposome formulation of bupivacaine: a Phase IV health economic trial in adult patients undergoing open colectomy. J Pain Res. 2012;5:567-72. doi: 10.2147/JPR.S38621. Epub 2012 Nov 20.
Results Reference
background
PubMed Identifier
29061282
Citation
Bhakta A, Glotzer O, Ata A, Tafen M, Stain SC, Singh PT. Analgesic efficacy of laparoscopic-guided transverse abdominis plane block using liposomal bupivacaine in bariatric surgery. Am J Surg. 2018 Apr;215(4):643-646. doi: 10.1016/j.amjsurg.2017.09.006. Epub 2017 Sep 20.
Results Reference
background
PubMed Identifier
29926357
Citation
Boerboom SL, de Haes A, Vd Wetering L, Aarts EO, Janssen IMC, Geurts JW, Kamphuis ET. Preperitoneal Bupivacaine Infiltration Reduces Postoperative Opioid Consumption, Acute Pain, and Chronic Postsurgical Pain After Bariatric Surgery: a Randomized Controlled Trial. Obes Surg. 2018 Oct;28(10):3102-3110. doi: 10.1007/s11695-018-3341-6.
Results Reference
background
PubMed Identifier
26204387
Citation
Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
Results Reference
background
PubMed Identifier
25282071
Citation
Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.
Results Reference
background
PubMed Identifier
22285545
Citation
Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
Results Reference
background
PubMed Identifier
24108252
Citation
Ilfeld BM, Malhotra N, Furnish TJ, Donohue MC, Madison SJ. Liposomal bupivacaine as a single-injection peripheral nerve block: a dose-response study. Anesth Analg. 2013 Nov;117(5):1248-56. doi: 10.1213/ANE.0b013e31829cc6ae.
Results Reference
background
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Use of Exparel for Postoperative Analgesia Following Bariatric Surgery
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