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Interscalene Block Versus Combined Infraclavicular-Anterior Suprascapular Blocks for Shoulder Surgery

U

University of Chile

Status

Completed

Conditions

Shoulder Pain
Surgical Procedure, Unspecified
Pain, Postoperative
Diaphragmatic Paralysis

Treatments

Procedure: Interscalene Block
Procedure: Infraclavicular - Anterior Supraescapular Nerve Blocks

Study type

Interventional

Funder types

Other

Identifiers

NCT05444517
OAIC 1248/22

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Interscalene Block
Active Comparator group
Description:
Patients randomized to receive an interscalene block.
Treatment:
Procedure: Interscalene Block
Infraclavicular-Anterior Supraescapular Nerve Blocks
Experimental group
Description:
Patients randomized to receive a combined infraclavicular plus anterior suprascapular nerve blocks.
Treatment:
Procedure: Infraclavicular - Anterior Supraescapular Nerve Blocks

Trial contacts and locations

1

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Central trial contact

Julián Aliste, MD

Data sourced from clinicaltrials.gov

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