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Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT01785940
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Pain, Shoulder Procedure: Interscalene block Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Ultrasound Guided Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty - An Open Label Feasibility Study
Actual Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Interscalene block
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
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 Measures :
  1. Pain scores: Visual analog scores [ Time Frame: first 24 postoperative hours ]
    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 :
  1. Range of motion [ Time Frame: First 24 postoperative hours ]
    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.


Other Outcome Measures:
  1. Analgesic consumption [ Time Frame: First 24 postoperative hours ]
    Total analgesic consumption per day and the number of boluses used per day will be prospectively collected

  2. Satisfaction score [ Time Frame: 5th postoperative day ]
    Patient satisfaction will be documented on a visual analogue scale where 0 is totally dissatisfied and 100 is totally satisfied.

  3. Readiness for home discharge [ Time Frame: first 24 postoperative hours ]
    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.

  4. Complication rates [ Time Frame: first 5 postoperative days ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785940


Locations
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Canada, Ontario
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Shalini Dhir, FRCPC St Joseph's Health Care centre, London, ontario

Publications of Results:
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Responsible Party: Shalini Dhir, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01785940     History of Changes
Other Study ID Numbers: 103329
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shalini Dhir, Lawson Health Research Institute:
Interscalene Block
Perineural catheter
Ropivacaine
Postoperative pain
Home regional
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents