Use of Exparel for Postoperative Analgesia Following Bariatric Surgery

NCT03975283 | Unknown Phase 4 FDA Drug

• 1 other identifier: SJHC80
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  10 days

Secondary Outcomes (4)

• Analog pain scores

  10 days (or until discharge)

• Post-operative nausea

  10 days (or until discharge)

• Post-operative Narcotic Use

  10 days (or until discharge)

• Hospital Length of Stay

  Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days.

Study Arms (2)

Exparel (Liposomal Bupivicaine)

EXPERIMENTAL

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.

Drug: Exparel 266 MG Per 20 ML Injection

0.25% Bupivicaine HCL

ACTIVE COMPARATOR

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.

Drug: Bupivacaine Hcl 0.25% Inj

Interventions

Exparel 266 MG Per 20 ML Injection DRUG

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.

Exparel (Liposomal Bupivicaine)

Bupivacaine Hcl 0.25% Inj DRUG

0.25% bupivacaine, 60mL total, divided into two 30mL syringes and delivered via TAP block on either side.

0.25% Bupivicaine HCL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Pacira Pharmaceuticals, Inc: collaborator

Related Publications (10)

• 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.

  PMID: 24733580 BACKGROUND

• 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.

  PMID: 23049275 BACKGROUND

• 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.

  PMID: 22900785 BACKGROUND

• 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.

  PMID: 23204866 BACKGROUND

• 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.

  PMID: 29061282 BACKGROUND

• 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.

  PMID: 29926357 BACKGROUND

• 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.

  PMID: 26204387 BACKGROUND

• 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.

  PMID: 25282071 BACKGROUND

• 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.

  PMID: 22285545 BACKGROUND

• 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.

  PMID: 24108252 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Margherita Cadeddu, MD, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Barlow

CONTACT

905-522-1155; kbarlow@stjoes.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 5, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share