Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty

Evaluation of Ultrasound Guided Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty - An Open Label Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Pain, Shoulder
• Intervention / Treatment: Procedure: Interscalene block

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 24 postoperative hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic consumption	Total analgesic consumption per day and the number of boluses used per day will be prospectively collected	First 24 postoperative hours
Satisfaction score	Patient satisfaction will be documented on a visual analogue scale where 0 is totally dissatisfied and 100 is totally satisfied.	5th postoperative day
Readiness for home discharge	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.	first 24 postoperative hours
Complication rates	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.	first 5 postoperative days

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Shalini Dhir, FRCPC, St Joseph's Health Care centre, London, ontario

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 11, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Postoperative pain; Ropivacaine; Interscalene Block; Perineural catheter; Home regional
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 103329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO