Trial | NCT02267044  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
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.
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 Started
Aug 31
2014
Primary Completion
Oct 31
2016
Study Completion
Apr 30
2017
Last Update
Oct 26
2018

Drug Ropivacaine

The drug used for the interscalene blocks

  • Other names: Naropin

Ropivacaine Single Shot Block Active Comparator

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

Ropivacaine Continuous block 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.

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.
No Results Posted