Exparel for Total Shoulder Pain (ETSP)
Primary Purpose
Chronic Shoulder Pain
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Exparel
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Shoulder Pain focused on measuring replacement, shoulder
Eligibility Criteria
Inclusion Criteria:
- Patients 18 years or older
- Patients admitted to TGH for total shoulder replacement surgery
- Subjects who have given written informed consent
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1 (30 participants)
Group 2 (30 participants)
Arm Description
Outcomes
Primary Outcome Measures
Duration of Surgery (in minutes)
Post-Operative VAS Scores (10 cm scale)
Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)
Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)
Post-Operative Narcotics Usage during PACU Stay (in Milligrams Morphine Equivalent; MME)
Post-Operative Narcotics Usage during first 72 hours after PACU discharge (Milligrams in Morphine Equivalents
Length of Hospital Stay (in hours)
Secondary Outcome Measures
Time spent Nerve Block Procedure (in minutes)
Cost of Adjuvant Therapy (in United States Dollar)
Full Information
NCT ID
NCT03739021
First Posted
September 13, 2018
Last Updated
July 15, 2019
Sponsor
University of South Florida
Collaborators
Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03739021
Brief Title
Exparel for Total Shoulder Pain
Acronym
ETSP
Official Title
Analgesic Requirements for Post-operative Pain Control in Total Shoulder Replacement Patients: Comparison of Interscalene Single Shot Exparel (Bupivacaine Liposome) Injections to Cervical Paravertebral Catheter With Ropivacaine (0.2% Continuous Infusion)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
November 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
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
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.
Detailed Description
Procedure Description:
The investigators commonly use these blocks for patients requiring total shoulder replacement: the patient is usually sedated with propofol. The patient is positioned in the lateral decubitus, or sitting position for this block. After the skin preparation and draping, the fingers of the non-operative hand separate the trapezius and levator scapulae muscle and a 25 gauge needle is used to anesthetize the skin and subcutaneous tissue.
The Trapezius and Levator Scapulae muscles are again separated with the non-operative hand and a 17 or 18 gauge insulated tuohy needle is inserted, which is attached to a nerve stimulator set at a current output of one to three milliamps, a frequency of two Hertz, and a pulse width of 200 to 300 microseconds. The needle is advanced towards the suprasternal notch until contact with the bony structures is made.
After contact with the bone the stylet of the needle is removed, the needle tip is walked off the bony structures in a lateral and slightly superior direction remaining on the plane of the line drawn from the dorsal spine of C6 to the suprasternal notch. After walking off of these bones structures the needle is advanced carefully in an anterior direction. As the needle is advanced there will be a motor response from the stimulator current. The muscles involved are usually the triceps, biceps, deltoids or major pectoral muscle but any muscle group of the upper limb would be acceptable for this block since the needle is now in contact with the posterior aspects of the roots of the brachial plexus. The tip of the needle at this point is situated between the anterior and middle scalene muscles and is in contact with the C6 root of the brachial plexus. At this point either a single-shot injection of Exparel will be performed, or a catheter for Ropivacaine will be inserted, as described below.
For catheter insertion: the nerve stimulator is removed from the needle and attached to the proximal end of the stimulating catheter and the tip of the catheter is inserted into the needle shaft. The nerve stimulator is usually set at a current output of one milliamp. The motor response should be unchanged. The catheter is advanced beyond the needle tip, if the motor response disappears, the catheter is careful drawn into the needle shaft and small adjustment to the needle, advancing slightly or withdrawing it slightly is done. This maneuver is repeated until the muscle twitch is unchanged during catheter advance. This indicates the catheter tip is now situated on the nerve root; the catheter is advanced 3 to 5 centimeter beyond the needle tip but not further than 5 centimeters. The needle is then removed without disturbing the catheter and the inner stylet of the catheter is also removed. The catheter position can be confirmed by attaching the nerve stimulator to the catheter, the motor response should be unchanged. The catheter is then subcutaneously tunneled and continuous infusion of Ropivacaine is inserted.
Intraoperative Management:
The intraoperative course will follow the standard of care practices. Doses/concentration of medications/agents used for the anesthetic management of the subjects enrolled in this trial may be adjusted when necessary to provide optimal subject care. Anesthesia will be induced with propofol, intravenous opioids, and other medication(s)/agent(s) at a concentration range/dose(s) based on the clinical need of the subject. Patient will be given succinylcholine to aid in intubation.
Anesthesia will be maintained in both groups with intravenous opioids, propofol and /or medication(s)/agent(s), including inhalation anesthetic agents, at a concentration range/dose(s) based on the clinical need of the subject.
Tracheal extubation will be performed at the end of anesthesia at which point the patient will be discharged to the post-anesthesia care unit.
Postoperative Management:
Upon arrival in the PACU, the (sub)investigator, using the visual analog scale, will clinically assess post-operative pain.
Assessment of patient pain levels involve a series of VAS testing postoperatively (upon arrival and every 30 minutes postoperatively until discharge from the PACU) using a 10 cm line. Patients that complain of pain intensity >5 cm/10 cm, will be given a standardized rescue intravenous dilaudid regimen, IV dilaudid at 0.4mg up to a max dose of 2mg prn q 2 hours or until a VAS of <5 is obtained. If a VAS score of <5 cannot be obtained, the PI may withdraw the patient from the study and administer another pain medication. Post-operative PACU narcotic consumption will be recorded and quantified.
All patients will be monitored with continuous pulse-oximetry. All post-operative complications will be captured.
Follow-up Period: All patients will have a planned hospital admission from the PACU. Pain will be assessed every 2 hours for the first 24 hours followed by every 4 hours until hospital discharge using the VAS scale. All post-operative complications will be captured. Post-PACU narcotic consumption will be recorded and quantified for the first 72 hours after PACU discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Shoulder Pain
Keywords
replacement, shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (30 participants)
Arm Type
Experimental
Arm Title
Group 2 (30 participants)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Duration of Surgery (in minutes)
Time Frame
Intraoperative
Title
Post-Operative VAS Scores (10 cm scale)
Time Frame
1 hour after surgery
Title
Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)
Time Frame
Intraoperative
Title
Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)
Time Frame
through study completion, 8 months-1 year (on average)
Title
Post-Operative Narcotics Usage during PACU Stay (in Milligrams Morphine Equivalent; MME)
Time Frame
through study completion, 8 months-1 year (on average)
Title
Post-Operative Narcotics Usage during first 72 hours after PACU discharge (Milligrams in Morphine Equivalents
Time Frame
First 72 hours after PACU discharge
Title
Length of Hospital Stay (in hours)
Time Frame
through study completion, 8 months-1 year (on average)
Secondary Outcome Measure Information:
Title
Time spent Nerve Block Procedure (in minutes)
Time Frame
Intraoperative
Title
Cost of Adjuvant Therapy (in United States Dollar)
Time Frame
through study completion, 8 months-1 year (on average)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older
Patients admitted to TGH for total shoulder replacement surgery
Subjects who have given written informed consent
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico M Camporesi, MD
Phone
8136009094
Email
ecampore@health.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Balouch, BA
Phone
8138444071
Email
maha_balouch@teamhealth.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The original records will be kept confidential. However, we will share the results of our study after removing individual identifiers.
IPD Sharing Time Frame
6 months (anticipated).
IPD Sharing Access Criteria
upon email request
Citations:
PubMed Identifier
30060719
Citation
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.
Results Reference
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Exparel for Total Shoulder Pain
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