Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

Study Overview
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Brief Summary
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Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery. The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.

Official Title
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A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

Conditions
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Pain, Postoperative, Shoulder Pain, Surgical Procedure, Unspecified, Diaphragmatic Paralysis

Intervention / Treatment
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* Procedure: Interscalene Block
* Procedure: Costoclavicular Infraclavicular Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing arthroscopic shoulder surgery American Society of Anesthesiologists classification 1-3 Body mass index between 20 and 35 Exclusion Criteria: Adults who are unable to give their own consent Pre-existing neuropathy Coagulopathy Obstructive or restrictive pulmonary disease Renal failure Hepatic failure Allergy to local anesthetics Pregnancy Prior surgery in the corresponding side of the neck or infraclavicular fossa Chronic pain syndromes requiring opioid intake at home

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interscalene Block<br>Patients randomized to receive an intesrcalene block. | Procedure: Interscalene Block<br>* Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.<br>|
| Experimental: Costoclavicular Infraclavicular Block<br>Patients randomized to receive a costoclavicular infraclavicular block. | Procedure: Costoclavicular Infraclavicular Block<br>* Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static pain at 30 minutes after arrival in the PACU | Evaluated with a NRS from 0 to 10 | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static pain at 60 minutes after arrival in the PACU | Evaluated with a NRS from 0 to 10 | 60 minutes | 
| Postoperative static pain at 2 hours | Evaluated with a NRS from 0 to 10 | 2 hours | 
| Postoperative static pain at 3 hours | Evaluated with a NRS from 0 to 10 | 3 hours | 
| Postoperative static pain at 6 hours | Evaluated with a NRS from 0 to 10 | 6 hours | 
| Postoperative static pain at 12 hours | Evaluated with a NRS from 0 to 10 | 12 hours | 
| Postoperative static pain at 24 hours | Evaluated with a NRS from 0 to 10 | 24 hours | 
| Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block | Ultrasound diagnosed HDP | 30 minutes post injection | 
| Incidence of HDP at 30 minutes after arrival to PACU | Ultrasound diagnosed HDP | 30 minutes after arrival to the PACU | 
| Block performance time | Time from skin disinfection until the end of local anesthetic injection | 1 hour before surgery | 
| Sensory and Motor block score | Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score | 30 minutes post injection | 
| Incidence of complete block | Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection | 30 minutes post injection | 
| Procedural pain during blocks | Evaluated with a NRS from 0 to 10 | 1 hour before surgery | 
| Onset time | Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points | 1 hour before surgery | 
| Intraoperative opioid requirements | Total amount of fentanyl required during general anesthesia | Intraoperative period | 
| Surgical duration | Time between skin incision and closure | Intraoperative period | 
| Postoperative opioid consumption | Total amount of morphine required during the first 24 hours after surgery | 24 hours after surgery | 
| Patient satisfaction | Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied) | 24 hours after surgery | 
| Block- and opioid-related side effects | Incidence of side effects | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alternative blocks, Postoperative Shoulder Analgesia, Hemidiaphragmatic Paralysis