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Clinical Trials/NCT03592056
NCT03592056
Terminated
Not Applicable

Incidence of Hemidiaphragmatic Paralysis Using 0.04% Levobupivacaine for Continuous Interscalene Brachial Plexus Blocks in Arthroscopic Shoulder Surgeries

Clinica las Condes, Chile1 site in 1 country30 target enrollmentStarted: August 10, 2018Last updated:
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ConditionsDiaphragmatic ParalysisPostoperative PainAcute PainShoulder PainShoulder Injury

Overview

Phase
Not Applicable
Status
Terminated
Sponsor
Clinica las Condes, Chile
Enrollment
30
Locations
1
Primary Endpoint
Hemidiaphragmatic paralysis before discharge
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief 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).

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Hemidiaphragmatic paralysis before discharge

Time Frame: 24 hours after surgery

Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography

Secondary Outcomes

  • Amount of local anesthetic (LA) boluses used before discharge.(24 hours after surgery)
  • Level of static pain 12 hours after arrival to PACU(12 hour after arrival to PACU)
  • Hemidiaphragmatic paralysis after surgery(30 minutes after arrival to post anesthetic care unit (PACU))
  • Level of static postoperative pain at 30 minutes of arrival to PACU(30 minutes after arrival to PACU)
  • Level of static postoperative pain 3 hour after arrival to PACU(3 hours after arrival to PACU)
  • level of static pain 6 hours after arrival to PACU(6 hours after arrival to PACU)
  • postoperative morphine equivalent consumption(24 hours after surgery)
  • Incidence of side effects before discharge(24 hours after surgery)
  • incidence of side effects after discharge with ambulatory continuous ISB.(24 to 72 hours after surgery)
  • Level of static postoperative pain 1 hour after arrival to PACU(60 minutes after arrival)
  • Level of static pain before discharge(24 hours post surgery)
  • Level of static pain during first day after the day of discharge(48 hours after surgery)
  • Motor block in PACU(30 minutes after arrival to PACU)
  • sensory block previous to discharge(24 hours after surgery)
  • motor block previous to discharge(24 hours after surgery)
  • intraoperative morphine equivalent consumption(intraoperative period)
  • Level of static pain during second day after the day of discharge(72 hours after surgery)
  • sensory block in PACU(30 minutes after arrival to PACU)

Investigators

Sponsor
Clinica las Condes, Chile
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Julián Aliste

Anesthesiololgist, Clinical Instructor

Clinica las Condes, Chile

Study Sites (1)

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