Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Chile
  • Metropolitan
    • Santiago, Metropolitan, Chile
      • Clinica Las Condes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing arthroscopic shoulder surgery and programmed to receive a continuous interscalene block as part of postoperative analgesia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemidiaphragmatic paralysis before discharge	Defined as less than 25% of basal diaphragm excursion evaluated with ultrasonography	24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinica las Condes, Chile

Publications and helpful links

General Publications

• Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.
• 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.
• Choromanski DW, Patel PS, Frederick JM, Lemos SE, Chidiac EJ. The effect of continuous interscalene brachial plexus block with 0.125% bupivacaine vs 0.2% ropivacaine on pain relief, diaphragmatic motility, and ventilatory function. J Clin Anesth. 2015 Dec;27(8):619-26. doi: 10.1016/j.jclinane.2015.03.006. Epub 2015 Jul 26.
• Fredrickson MJ, Price DJ. Analgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ultrasound-guided C5-6 root/superior trunk perineural ambulatory catheter. Br J Anaesth. 2009 Sep;103(3):434-9. doi: 10.1093/bja/aep195. Epub 2009 Jul 16.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): July 23, 2019
• Study Completion (Actual): July 23, 2019

Study Registration Dates

• First Submitted: July 6, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: hemidiaphragmatic paralysis; continuous plexus block; interscalene plexus block; diluted local anesthetic infusion; ambulatory regional analgesia; ambulatory continuous nerve block; continuous local anesthetic infusion
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Respiratory Insufficiency; Shoulder Pain; Acute Pain; Paralysis; Shoulder Injuries; Respiratory Paralysis
• Other Study ID Numbers: MA012018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No