Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

Terminated

• Conditions: Acute Pain; Postoperative Pain; Diaphragmatic Paralysis; Shoulder Pain; Shoulder Injury

• Registration Number: NCT03592056
• Lead Sponsor: Clinica las Condes, Chile

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-19
• Study Start: 2018-08-10
• Primary Completion: 2019-07-23
• Study Completion: 2019-07-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemidiaphragmatic paralysis before discharge	24 hours after surgery	Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography

Secondary Outcome Measures

Name	Time	Method
Amount of local anesthetic (LA) boluses used before discharge.	24 hours after surgery	boluses of LA administered by the patient controlled infusor in adidiotn to a basal rate.
Level of static pain 12 hours after arrival to PACU	12 hour after arrival to PACU	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
Hemidiaphragmatic paralysis after surgery	30 minutes after arrival to post anesthetic care unit (PACU)	Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography
Level of static postoperative pain at 30 minutes of arrival to PACU	30 minutes after arrival to PACU	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
Level of static postoperative pain 3 hour after arrival to PACU	3 hours after arrival to PACU	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
level of static pain 6 hours after arrival to PACU	6 hours after arrival to PACU	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
postoperative morphine equivalent consumption	24 hours after surgery	total amount of morphine equivalent opioid requirement in milligrams
Incidence of side effects before discharge	24 hours after surgery	presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block.
incidence of side effects after discharge with ambulatory continuous ISB.	24 to 72 hours after surgery	presence of side effects (vascular puncture, Horner syndrome, hoarseness, LA systemic toxicity, catheter dislodgement, catheter insertion site leak), related with the block.
Level of static postoperative pain 1 hour after arrival to PACU	60 minutes after arrival	level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
Level of static pain before discharge	24 hours post surgery	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
Level of static pain during first day after the day of discharge	48 hours after surgery	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
Motor block in PACU	30 minutes after arrival to PACU	paresia or paralysis in operated side, shoulder, arm, forearm or hand
sensory block previous to discharge	24 hours after surgery	loss of sensation to cold in lateral deltoid area
motor block previous to discharge	24 hours after surgery	paresia or paralysis in operated side shoulder, arm, forearm or hand
intraoperative morphine equivalent consumption	intraoperative period	total amount of morphine equivalent opioid requirement in milligrams
Level of static pain during second day after the day of discharge	72 hours after surgery	Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10
sensory block in PACU	30 minutes after arrival to PACU	loss of sensation to cold in lateral deltoid area

Trial Locations

Locations (1)

Clínica Las Condes; 🇨🇱 Santiago, Metropolitan, Chile