Clinical trial NCT03411343: Interscalene Block Versus Costoclavicular Block for Shoulder Surgery
Official title: A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Shoulder Pain
Surgical Procedure, Unspecified
Diaphragmatic Paralysis
Keywords: Postoperative Shoulder Analgesia
Hemidiaphragmatic Paralysis
Alternative blocks
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Static pain at 30 minutes after arrival in the PACU
timeFrame: 30 minutes
Secondary outcomes:
measure: Static pain at 60 minutes after arrival in the PACU
timeFrame: 60 minutes
measure: Postoperative static pain at 2 hours
timeFrame: 2 hours
measure: Postoperative static pain at 3 hours
timeFrame: 3 hours
measure: Postoperative static pain at 6 hours
timeFrame: 6 hours
measure: Postoperative static pain at 12 hours
timeFrame: 12 hours
measure: Postoperative static pain at 24 hours
timeFrame: 24 hours
measure: Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block
timeFrame: 30 minutes post injection
measure: Incidence of HDP at 30 minutes after arrival to PACU
timeFrame: 30 minutes after arrival to the PACU
measure: Block performance time
timeFrame: 1 hour before surgery
measure: Sensory and Motor block score
timeFrame: 30 minutes post injection
measure: Incidence of complete block
timeFrame: 30 minutes post injection
measure: Procedural pain during blocks
timeFrame: 1 hour before surgery
measure: Onset time
timeFrame: 1 hour before surgery
measure: Intraoperative opioid requirements
timeFrame: Intraoperative period
measure: Surgical duration
timeFrame: Intraoperative period
measure: Postoperative opioid consumption
timeFrame: 24 hours after surgery
measure: Patient satisfaction
timeFrame: 24 hours after surgery
measure: Block- and opioid-related side effects
timeFrame: 1 week
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitana
Study officials:
References:
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