Effective Pain Management of Interscalene Blocks During Shoulder Surgery

Overview

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.

Full Title of Study: “Effective Pain Management of Continuous Versus Single Shot Injection Interscalene Block During Shoulder Replacement Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

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.

Interventions

  • Drug: Ropivacaine
    • The drug used for the interscalene blocks

Arms, Groups and Cohorts

  • Active Comparator: Ropivacaine Single Shot Block
    • Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
    • Total Morphine Sulfate equivalence consumption for each post-operative day while in the hospital will be collected through Electronic medical record.
  • Pain control Satisfaction Score
    • Time Frame: 10 day post operative
    • Patient’s post operative pain control satisfaction score will be obtained at the first post operative follow up visit with the physician which is expected to occur on avearage 10 days after surgery

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • TriHealth Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Samer Hasan, MD, Principal Investigator, Cincinnati Sportsmedicine and Orthopaedic Center
    • Robert Rolf, MD, Principal Investigator, Beacon Orthopaedic Center

References

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.

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