Clinical trial NCT02267044: Effective Pain Management of Interscalene Blocks During Shoulder Surgery
Official title: Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Osteoarthritis, Unspecified Shoulder
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient.

Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.

Detailed description: This is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.

Eligibility criteria: Inclusion Criteria:

* Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement
* patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and
* must be able to understand and agree to follow study protocol.

Exclusion Criteria:

* severe bronchopulmonary disease,
* oxygen dependent,
* existing nerve injury,
* BMI \> 40,
* coagulation disorders,
* allergy to ropivicaine,
* history of drug or alcohol abuse,
* American Academy of Anaesthesiologists physical status classification \> lll,
* pregnant women.

Primary outcomes:
measure: Pain Score Measure
timeFrame: participants will be followed for the duration of the hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Morphine Sulfate Equivalence consumption
timeFrame: participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days
measure: Pain control Satisfaction Score
timeFrame: 10 day post operative
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: Cincinnati Sportsmedicine and Orthopaedic Center
name: Samer Hasan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beacon Orthopaedic Center
name: Robert Rolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. doi: 10.1093/bja/81.4.603.