Completed

NCT Number: NCT02267044

Effective Pain Management of Interscalene Blocks During Shoulder 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.

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Key information

Conditions

Primary Osteoarthritis, Unspecified Shoulder

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine

Drug

The drug used for the interscalene blocks

Other names: Naropin

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

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

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Oct 17, 2014
Registry last updated: Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.