Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Orthopedic, Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 20 - 100 |
| Updated: | 12/14/2018 |
| Start Date: | April 2016 |
| End Date: | December 2019 |
Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for
pain control after total shoulder replacements. Each method will be assessed in terms of post
operative pain scores, pain medication consumption, length of stay, complications (nerve
injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The
aims of this study will be achieved through a randomized controlled trial and
cost-effectiveness analysis.
pain control after total shoulder replacements. Each method will be assessed in terms of post
operative pain scores, pain medication consumption, length of stay, complications (nerve
injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The
aims of this study will be achieved through a randomized controlled trial and
cost-effectiveness analysis.
After the decision to proceed with shoulder replacement surgery, patients will be asked to
participate in this randomized trial.
Consent will be completed after explanation of each treatment group and the data to be
collected. Patient age, gender, BMI, and American Society of Anesthesiologists (ASA) score
will be recorded as baseline demographic data.
Patients will be randomized into one of the two treatment groups by simple randomization into
one of two groups: Group 1 will receive interscalene nerve block, Group 2 will receive
liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site.
The surgeon will perform randomization when the patient enters the preoperative area.
The surgeon at each site will be trained prior to enrollment on the correct way to perform
Exparel injections intraoperatively. Patients in the interscalene nerve block group will be
given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.
Surgical time, type of implant, incision length, and amount of anesthesia required will be
recorded for each patient.
Patients will record their pain scores, medication and side effects data after surgery until
96 hours after surgery. Our primary analysis data points for pain scores and pain medication
use will be 24 hours, 48 hours, 72 hours, 96 hours, and 2 weeks after surgery. The outcome
assessor on the study team will be blinded to the treatment group.
participate in this randomized trial.
Consent will be completed after explanation of each treatment group and the data to be
collected. Patient age, gender, BMI, and American Society of Anesthesiologists (ASA) score
will be recorded as baseline demographic data.
Patients will be randomized into one of the two treatment groups by simple randomization into
one of two groups: Group 1 will receive interscalene nerve block, Group 2 will receive
liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site.
The surgeon will perform randomization when the patient enters the preoperative area.
The surgeon at each site will be trained prior to enrollment on the correct way to perform
Exparel injections intraoperatively. Patients in the interscalene nerve block group will be
given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.
Surgical time, type of implant, incision length, and amount of anesthesia required will be
recorded for each patient.
Patients will record their pain scores, medication and side effects data after surgery until
96 hours after surgery. Our primary analysis data points for pain scores and pain medication
use will be 24 hours, 48 hours, 72 hours, 96 hours, and 2 weeks after surgery. The outcome
assessor on the study team will be blinded to the treatment group.
Inclusion Criteria:
- Degenerative changes of the shoulder joint (documented by radiographs) in patients
planning total joint replacement with one of the study's four fellowship-trained
orthopaedic surgeons.
- Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain
issues will be included.
Exclusion Criteria:
- Allergy to liposomal bupivacaine
- Contraindications to the interscalene nerve block such as:
- Preexisting neurologic defects
- Local anesthetic allergy
- Coagulopathy
- Contralateral phrenic nerve dysfunction
- Severe chronic obstructive pulmonary disease
We found this trial at
1
site
11055 Little Patuxent Parkway
Columbia, Maryland 21044
Columbia, Maryland 21044
Principal Investigator: Uma Srikumaran, MD, MBA
Phone: 443-546-1558
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