Use of Exparel for Postoperative Analgesia Following Bariatric Surgery

Post Operative Pain Clinical Trial

Official title:

Use of Long-acting Local Analgesia in Bariatrics: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03975283
• Other study ID #: SJHC80
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2019
• Est. completion date: August 2021

Study information

• Verified date: June 2019
• Source: McMaster University
• Contact: Karen Barlow
• Phone: 905-522-1155
• Email: kbarlow[@]stjoes.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Exparel 266 MG Per 20 ML Injection
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.
• Bupivacaine Hcl 0.25% Inj
0.25% bupivacaine, 60mL total, divided into two 30mL syringes and delivered via TAP block on either side.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Pacira Pharmaceuticals, Inc

References & Publications (10)

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. — View 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. — View 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. — View 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. — View Citation

Cohen SM. Extended pain relief trial utilizing infiltration of Exparel(®), 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 days (or until discharge)
Secondary	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)	10 days (or until discharge)
Secondary	Post-operative Narcotic Use	Postoperative narcotic use will be recorded in morphine equivalent units and recorded via their electronic medical record.	10 days (or until discharge)
Secondary	Hospital Length of Stay	Length of stay calculated in hours	Total length of stay will be calculated from registration until discharge to home; usually spans 2-5 days.