Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty

NCT01785940 | Completed

• 1 other identifier: 103329
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Total shoulder surgeries are associated with considerable postoperative pain which may prevent rehabilitation and early discharge from the hospital. Continuous interscalene blocks with home infusions are commonly performed for pain relief following total shoulder arthroplasties. We want to evaluate the time to readiness for discharge following interscalene blocks in patients undergoing total shoulder arthroplasties.

Conditions

Pain, Shoulder

Keywords

Interscalene Block; Perineural catheter; Ropivacaine; Postoperative pain; Home regional

Outcome Measures

Primary Outcomes (1)

• Pain scores: Visual analog scores

  The patients will be evaluated for home discharge based on the degree of analgesia (VAS scores of \< 40/100 on movement) at arrival to PACU, and at every 2 hours for the first 6 hours postoperatively and every 4 hourly till 6 AM on the morning of POD1 and at 23 postoperative hours.

  first 24 postoperative hours

Secondary Outcomes (1)

• Range of motion

  First 24 postoperative hours

Other Outcomes (4)

• Analgesic consumption

  First 24 postoperative hours

• Satisfaction score

  5th postoperative day

• Readiness for home discharge

  first 24 postoperative hours

Study Arms (1)

Interscalene block

EXPERIMENTAL

Interscalene catheters will be placed under aseptic precautions in each patient by one of the investigators using combined peripheral nerve stimulation and ultrasound guidance to get twitch in the C5-C6 dermatomes and documented spread of injectate near C5-6 nerve roots. Twenty mL of 0.2% ropivacaine will be injected while documenting adequate drug spread under ultrasound. After 20 min of injection, the interscalene nerve block will be evaluated and considered successful with inability to abduct the shoulder and a decrease in perceived sensation to cold of the skin over the deltoid muscle.

Procedure: Interscalene block

Interventions

Interscalene block PROCEDURE

Interscalene catheters will be placed under aseptic precautions in each patient by one of the investigators using combined peripheral nerve stimulation and ultrasound guidance to get twitch in the C5-C6 dermatomes and documented spread of injectate near C5-6 nerve roots. Twenty mL of 0.2% ropivacaine will be injected while documenting adequate drug spread under ultrasound. After 20 min of injection, the interscalene nerve block will be evaluated and considered successful with inability to abduct the shoulder and a decrease in perceived sensation to cold of the skin over the deltoid muscle.

Interscalene block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females of 18-80 years of age, scheduled to undergo elective shoulder arthroplasty.
• ASA Class I, II, III

You may not qualify if:

• Patients with associated significant cardiac and respiratory disease.
• Patients who will need hospitalization due to reason other than the planned surgery.
• Patients with coexisting sleep apnea or morbid obesity (BMI\> 35).
• Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
• Psychiatric illnesses.
• Lack of informed consent.
• Allergy to any of the drugs used in the study.
• Contraindications to interscalene block

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• Ilfeld BM, Wright TW, Enneking FK, Mace JA, Shuster JJ, Spadoni EH, Chmielewski TL, Vandenborne K. Total shoulder arthroplasty as an outpatient procedure using ambulatory perineural local anesthetic infusion: a pilot feasibility study. Anesth Analg. 2005 Nov;101(5):1319-1322. doi: 10.1213/01.ANE.0000180199.52383.CE.

  PMID: 16243987 RESULT

MeSH Terms

Conditions

Shoulder Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Shalini Dhir, FRCPC

  St Joseph's Health Care centre, London, ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)