Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

NCT03592056 | Terminated

• 1 other identifier: MA012018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Diaphragmatic Paralysis; Postoperative Pain; Acute Pain; Shoulder Pain; Shoulder Injury

Keywords

hemidiaphragmatic paralysis; continuous plexus block; interscalene plexus block; diluted local anesthetic infusion; ambulatory regional analgesia; ambulatory continuous nerve block; continuous local anesthetic infusion

Outcome Measures

Primary Outcomes (1)

• Hemidiaphragmatic paralysis before discharge

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

  24 hours after surgery

Secondary Outcomes (18)

• Hemidiaphragmatic paralysis after surgery

  30 minutes after arrival to post anesthetic care unit (PACU)

• Amount of local anesthetic (LA) boluses used before discharge.

  24 hours after surgery

• Level of static postoperative pain at 30 minutes of arrival to PACU

  30 minutes after arrival to PACU

• Level of static postoperative pain 1 hour after arrival to PACU

  60 minutes after arrival

• Level of static postoperative pain 3 hour after arrival to PACU

  3 hours after arrival to PACU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age between 18 and 80 years
• American Society of Anesthesiologists classification 1-3
• body mass index between 20 and 35

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica las Condes, Chile: lead

Study Sites (1)

Clínica Las Condes

Santiago, Metropolitan, Chile

Location

Related Publications (4)

• 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.

  PMID: 27941477 RESULT

• 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.

  PMID: 26216250 RESULT

• 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.

  PMID: 19608563 RESULT

• 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.

  PMID: 16331304 RESULT

MeSH Terms

Conditions

Respiratory Paralysis; Pain, Postoperative; Acute Pain; Shoulder Pain; Shoulder Injuries

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiololgist, Clinical Instructor

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 19, 2018
• Study Start: August 10, 2018
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)