Clinical trial NCT05444517: Interscalene Block Versus Combined Infraclavicular-Anterior Suprascapular Blocks for Shoulder Surgery
Official title: A Randomized Comparison Between Interscalene And Combined Infraclavicular-Anterior Suprascapular Nerve Blocks For Arthroscopic Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Shoulder Pain
Surgical Procedure, Unspecified
Diaphragmatic Paralysis
Keywords: Postoperative Shoulder Analgesia
Diaphragmatic Paralysis
Alternative Blocks
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 50
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: Postoperative analgesia after shoulder surgery remains a challenge in patients with preexisting pulmonary pathology, as interscalene brachial plexus block (ISB), the standard nerve block for shoulder surgery, carries a prohibitive risk of hemidiaphragmatic paralysis (HDP). Although several diaphragm-sparing nerve blocks have been proposed, none seems to offer equivalent analgesia to ISB while avoiding HDP altogether. For instance, even costoclavicular blocks, which initially fulfilled both requirements, were subsequently found to result in a non-negligible 5%-incidence of HDP.

In this randomized trial, the authors set out to compare ISB and combined infraclavicular block-anterior suprascapular nerve blocks (ICB-ASSNB) for patients undergoing arthroscopic shoulder surgery. The authors hypothesized that ICB-ASSNB would provide equivalent postoperative analgesia to ISB 30 minutes after shoulder surgery and therefore designed the current study as an equivalence trial.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing arthroscopic shoulder surgery
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 kg/mt2

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Obstructive or restrictive pulmonary disease (assessed by history and physical examination)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs)
* Pregnancy
* Prior surgery in the neck or infraclavicular region
* Chronic pain syndromes requiring opioid intake at home

Primary outcomes:
measure: Static pain 30 minutes after arrival in the post anesthesia care unit (PACU)
timeFrame: 30 minutes after PACU arrival
Secondary outcomes:
measure: Static pain 1 hour after arrival in the PACU
timeFrame: 1 hour after PACU arrival
measure: Static pain 3 hours after arrival in the PACU
timeFrame: 3 hours after PACU arrival
measure: Static pain 6 hours after arrival in the PACU
timeFrame: 6 hours after PACU arrival
measure: Static pain 12 hours after arrival in the PACU
timeFrame: 12 hours after PACU arrival
measure: Static pain 24 hours after arrival in the PACU
timeFrame: 24 hours after PACU arrival
measure: Static pain 36 hours after arrival in the PACU
timeFrame: 36 hours after PACU arrival
measure: Static pain 48 hours after arrival in the PACU
timeFrame: 48 hours after PACU arrival
measure: Block performance time
timeFrame: 1 hour before surgery
measure: Intensity of pain during block procedure
timeFrame: 1 hour before surgery
measure: Incidence of nerve block side effects
timeFrame: 0 minutes after skin disinfection to 30 minutes after the nerve block
measure: Sensory and motor block score
timeFrame: 30 minutes after the ending time of local anesthetic injection
measure: Block onset time
timeFrame: 1 hour before surgery
measure: Basal diaphragmatic function
timeFrame: 1 hour before surgery
measure: Incidence of hemidiaphragmatic paralysis (HDP) at 30 minutes after interscalene or infraclavicular-suprascapular block
timeFrame: 30 minutes after the ending time of local anesthetic injection
measure: Incidence of HDP 30 minutes after PACU arrival
timeFrame: 30 minutes after PACU arrival
measure: Duration of surgery
timeFrame: 4 hours after skin incision
measure: Postoperative opioid related side effects
timeFrame: 48 hours after PACU arrival
measure: Intraoperative opioid requirements
timeFrame: Intraoperative period
measure: Postoperative opioid consumption
timeFrame: 48 hours after PACU arrival
measure: Patient satisfaction
timeFrame: 24 hours after PACU arrival
measure: Persistent neurologic deficit
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitana
Study officials:
affiliation: University of Chile
name: Julián Aliste, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
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citation: Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print.
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