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Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty

Primary Purpose

Pain, Shoulder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interscalene block
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Shoulder focused on measuring Interscalene Block, Perineural catheter, Ropivacaine, Postoperative pain, Home regional

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • St. Joseph's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interscalene block

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Range of motion
The patients will be evaluated for achievement and maintenance of at least 50% of expected range of motion at arrival to PACU, 6 hours postoperatively and on the morning of POD1 and at 23 postoperative hours.

Full Information

First Posted
February 5, 2013
Last Updated
February 11, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01785940
Brief Title
Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty
Official Title
Evaluation of Ultrasound Guided Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty - An Open Label Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The number of shoulder replacement surgeries is increasing over the years and it is expected to continue as the population ages (1). This necessitates adequate pain control in the immediate and early postoperative period when pain levels are typically high. Adequate analgesia ensures patient comfort and the ability to perform physical therapy exercises associated with positive surgical outcomes (2-3). Interscalene brachial plexus block (ISB) is commonly performed to provide analgesia for patients undergoing surgical procedures in the shoulder region. Either single injection blocks or continuous perineural infusions are performed along with oral medications for better pain control in these patients. Compared with intravenous opioids, ISB is known to produce superior analgesia after major shoulder surgery (4,5). There are reports of outpatient TSA discharged directly from the recovery room following the use of continuous ISB but achievement of adequate range of motion were not tested in them (6). Consequently, ambulatory ISB may offer decreased hospitalization while ensuring adequate analgesia after TSA. Ilfeld et al (7) prospectively compared ISB and opioids regarding the time to readiness for discharge following TSA, which was followed by many other studies demonstrating the safety and efficacy of continuous ISB for TSA (8, 9). Ilfeld et al (6) showed that discharge criteria were 21 (16-41) h with the use of ISB as compared to 51 (37-90) h for those receiving perineural normal saline. In our centre, healthy patients requiring shoulder arthroplasty usually remain as in-patients for management of pain. Perineural infusions may be continued at home using a portable infusion pump after discharge. With the use of disposable portable infusion pump for continuous ISB, it may be feasible to discharge patients and reduce hospitalization time. Although the study by Ilfeld et al showed continuous ISB allowing earlier home discharge following TSA, the patients in the study were evaluated for readiness to discharge on POD1 at 10 AM rather than the earliest times possible. Another interesting finding is that all patients received ropivacaine infusions till 6 AM of POD1 but the authors also claim to have discharged few patients on the same afternoon after the surgery. The block infusions reported in previous studies are higher than used at our institute. There is also conflicting evidence that although continuous ISB provides adequate analgesia, they seldom impact early functional rehabilitation (10). With this background we want to evaluate the earliest times for the achievement of readiness to discharge with the use of ISB following TSA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Shoulder
Keywords
Interscalene Block, Perineural catheter, Ropivacaine, Postoperative pain, Home regional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Interscalene block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain scores: Visual analog scores
Description
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.
Time Frame
first 24 postoperative hours
Secondary Outcome Measure Information:
Title
Range of motion
Description
The patients will be evaluated for achievement and maintenance of at least 50% of expected range of motion at arrival to PACU, 6 hours postoperatively and on the morning of POD1 and at 23 postoperative hours.
Time Frame
First 24 postoperative hours
Other Pre-specified Outcome Measures:
Title
Analgesic consumption
Description
Total analgesic consumption per day and the number of boluses used per day will be prospectively collected
Time Frame
First 24 postoperative hours
Title
Satisfaction score
Description
Patient satisfaction will be documented on a visual analogue scale where 0 is totally dissatisfied and 100 is totally satisfied.
Time Frame
5th postoperative day
Title
Readiness for home discharge
Description
The time from the arrival in PACU to the attainment of home discharge criteria following exercises will be noted as the time to readiness for discharge.
Time Frame
first 24 postoperative hours
Title
Complication rates
Description
Adverse events such as local anesthetic toxicity, neurological deficits respiratory insufficiency will be prospectively collected. The failure rate and the number of attempts will also be recorded.
Time Frame
first 5 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and females of 18-80 years of age, scheduled to undergo elective shoulder arthroplasty. ASA Class I, II, III Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Dhir, FRCPC
Organizational Affiliation
St Joseph's Health Care centre, London, ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16243987
Citation
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.
Results Reference
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Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty

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