Overview

This trial is active, not recruiting.

Condition primary osteoarthritis, unspecified shoulder
Treatment ropivacaine
Sponsor TriHealth Inc.
Start date August 2014
End date October 2016
Trial size 76 participants
Trial identifier NCT02267044, 14061

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery
ropivacaine Naropin
The drug used for the interscalene blocks
(Active Comparator)
Continuous Interscalene block patients will receive a shot of up to 30ml of 0.5% Ropivacaine and then a catheter is placed. The catheter is secured with Dermabond and Tegaderm. Once surgery is complete, the catheter is connected to a pain ball system which holds 400ml of 0.2% Ropivacaine local anesthetic. The rate is locked in at 8ml/hr. Catheter is pulled once the pain ball is empty.
ropivacaine Naropin
The drug used for the interscalene blocks

Primary Outcomes

Measure
Pain Score Measure
time frame: participants will be followed for the duration of the hospital stay, an expected average of 3 days

Secondary Outcomes

Measure
Morphine Sulfate Equivalence consumption
time frame: participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days
Pain control Satisfaction Score
time frame: 10 day post operative

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery
Principal investigator Samer Hasan, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by TriHealth Inc..