Exparel for Total Shoulder Pain

NCT03739021 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 37089
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total shoulder surgery (arthroplasty) is a widely successful method of treating shoulder arthritis. Although the goal of the procedure is pain relief, post-operative pain is unavoidable. Pain is a common side effect that many patients undergo while in the clinical setting and is a vital factor in influencing the length of hospital stay, narcotic usage, as well as overall patient satisfaction. Post-operative pain management typically involves elevated usage of narcotics, which is a concern among clinicians and researchers alike. To combat this issue, research is examining intraoperative procedures as a means of reducing post-operative pain scores. Research has discovered the advantages of utilizing local anesthetic techniques as opposed to just general anesthesia. Local anesthetic blocks function by preventing the generation of nerve impulses by increasing the action-potential threshold, thereby inhibiting movement. Previous studies have demonstrated the success of local anesthetic interscalene blocks across several medical procedures. For instance, Exparel (liposomal bupivacaine) has been effective in reducing post-operative pain scores in tonsillectomy and shoulder arthroplasty. Another local anesthetic, Ropivacaine, has been found to be potent when utilized via a cervical paravertebral catheter among thoracic procedures. Our study will compare Exparel (bupivacaine liposome) with Ropivacaine continuous infusion for post-operative pain scores in total shoulder surgery patients. Additionally, we will collect data on complications, length of stay, and other variables.

Conditions

Chronic Shoulder Pain

Keywords

replacement; shoulder

Outcome Measures

Primary Outcomes (7)

• Duration of Surgery (in minutes)

  Intraoperative

• Post-Operative VAS Scores (10 cm scale)

  1 hour after surgery

• Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)

  Intraoperative

• Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)

  through study completion, 8 months-1 year (on average)

• Post-Operative Narcotics Usage during PACU Stay (in Milligrams Morphine Equivalent; MME)

  through study completion, 8 months-1 year (on average)

• Post-Operative Narcotics Usage during first 72 hours after PACU discharge (Milligrams in Morphine Equivalents

  First 72 hours after PACU discharge

• Length of Hospital Stay (in hours)

  through study completion, 8 months-1 year (on average)

Secondary Outcomes (2)

• Time spent Nerve Block Procedure (in minutes)

  Intraoperative

• Cost of Adjuvant Therapy (in United States Dollar)

  through study completion, 8 months-1 year (on average)

Study Arms (2)

Group 1 (30 participants)

EXPERIMENTAL

Drug: Exparel

Group 2 (30 participants)

EXPERIMENTAL

Drug: Ropivacaine

Interventions

Exparel DRUG

Single shot of the Bupivacaine Liposome, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.

Group 1 (30 participants)

Ropivacaine DRUG

Continuous infusion of Ropivacaine via catheter, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.

Group 2 (30 participants)

Eligibility Criteria

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

You may qualify if:

• Patients 18 years or older
• Patients admitted to TGH for total shoulder replacement surgery
• Subjects who have given written informed consent

You may not qualify if:

• Patients with allergic reactions to Exparel or Ropivacaine
• Female patients who are pregnant
• Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)

Sponsors & Collaborators

• University of South Florida: lead
• Pacira Pharmaceuticals, Inc: collaborator

Related Publications (1)

• Olson MD, Moore EJ, Price DL. A Randomized Single-Blinded Trial of Posttonsillectomy Liposomal Bupivacaine among Adult Patients. Otolaryngol Head Neck Surg. 2018 Nov;159(5):835-842. doi: 10.1177/0194599818791773. Epub 2018 Jul 31.

  PMID: 30060719 BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Enrico M Camporesi, MD

CONTACT

8136009094; ecampore@health.usf.edu

Maha Balouch, BA

CONTACT

8138444071; maha_balouch@teamhealth.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, open label study. A series of 60 sealed envelopes: 30 "Exparel single shot" and 30 "Ropivacaine catheter" will be blindly open for each of the 60 patients when collecting informed consent.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: November 13, 2018
• Study Start: November 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: November 15, 2020
• Last Updated: July 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months (anticipated).
• Access Criteria: upon email request