TerminatedNot Applicable

Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

Stopped: interim analysis proved that protocol intervention had no preventive effect

Chile30 participantsStarted 2018-08-10

Plain-language summary

Interscalene brachial plexus block (ISB) 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. Continuous ISBs have not avoided this complication with the reported and regularly used local anesthetic dilutions (i.e. 0.125% bupivacaine, 0.25% ropivacaine, etc). This observational study will register the incidence of HDP in continuous interscalene block (CISB) using a very diluted solution of levobupivacaine (0.04%) in patients undergoing arthroscopic shoulder surgery. The main objective of this study is to determine the frequency of HDP the first postoperative day before patient discharge(POD).

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age between 18 and 80 years * 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 (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) * 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 ipsilateral neck region * chronic pain conditions

What they're measuring

Hemidiaphragmatic paralysis before discharge

Timeframe: 24 hours after surgery

Trial details

NCT IDNCT03592056

SponsorClinica las Condes, Chile

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-07-23