Effective Pain Management of Interscalene Blocks During Shoulder Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Osteoarthritis, Unspecified Shoulder
• Intervention / Treatment: Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Ropivacaine; The drug used for the interscalene blocks; Other Names: Naropin
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.	Drug: Ropivacaine; The drug used for the interscalene blocks; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score Measure	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.	participants will be followed for the duration of the hospital stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Sulfate Equivalence consumption	Total Morphine Sulfate equivalence consumption for each post-operative day while in the hospital will be collected through Electronic medical record.	participants morphine sulfate consumption will be gathered for the duration of the hospital stay, an expected average of 3 days
Pain control Satisfaction Score	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	10 day post operative

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Samer Hasan, MD, Cincinnati Sportsmedicine and Orthopaedic Center; Principal Investigator: Robert Rolf, MD, Beacon Orthopaedic Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 14061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED