Fracture of Shoulder and Upper Arm Clinical Trial
Official title:
A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation
| NCT number | NCT02472314 |
| Other study ID # | 2014-193 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | June 2015 |
| Est. completion date | May 2017 |
| Verified date | December 2023 |
| Source | Wayne State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | May 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients undergoing shoulder arthroplasty under general anesthesia - Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia - Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3 - Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines. - Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond. - Patients available for follow up routine post-operative clinic visits, per standard of care. Exclusion Criteria: - Contraindications to regional anesthesia - Significant peripheral neuropathy or neurological disorder affecting the upper extremity - Contraindication to a component of multimodal analgesia - Pregnancy - Opioid tolerance - Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Wayne State University Physician Group | Dearborn | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Wayne State University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of Analgesia | Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively | 30 days | |
| Secondary | Post Operative American Shoulder and Elbow Surgeons (ASES) | American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome. | Preoperative, 6 weeks and last follow up | |
| Secondary | Subjective Shoulder Value (SSV) | Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100% | Pre-operative, 6 weeks and last Follow up | |
| Secondary | Incidence of Nerve Injury | Neuropraxia on the treatment side | During hospital stay and at 2 weeks and 6 weeks post-operatively | |
| Secondary | Post Operative Opioid Consumption | Cumulative amount of opioids administered during the time frame | During hospital stay up to 48 hours after surgery |