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Clinical Trials/NCT02267044
NCT02267044
Completed
Not Applicable

Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery

TriHealth Inc.1 site in 1 country76 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Primary Osteoarthritis, Unspecified Shoulder
Sponsor
TriHealth Inc.
Enrollment
76
Locations
1
Primary Endpoint
Pain Score Measure
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
April 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Ropivacaine Single Shot Block

Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery

Intervention: Ropivacaine

Ropivacaine Continuous block

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.

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Pain Score Measure

Time Frame: participants will be followed for the duration of the hospital stay, an expected average of 3 days

Patients will be assessed for pain levels by visual analog scale while in the hospital per nursing protocol. Electronic Medical Record will be used to acquire pain scores.

Secondary Outcomes

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

Study Sites (1)

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