Clinical trial NCT01785940: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Shoulder
Keywords: Interscalene Block
Perineural catheter
Ropivacaine
Postoperative pain
Home regional
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain scores: Visual analog scores
timeFrame: first 24 postoperative hours
Secondary outcomes:
measure: Range of motion
timeFrame: First 24 postoperative hours
Other outcomes:
measure: Analgesic consumption
timeFrame: First 24 postoperative hours
measure: Satisfaction score
timeFrame: 5th postoperative day
measure: Readiness for home discharge
timeFrame: first 24 postoperative hours
measure: Complication rates
timeFrame: first 5 postoperative days
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: St Joseph's Health Care centre, London, ontario
name: Shalini Dhir, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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.