AzTrials
AzTrials

Diaphragmatic ParalysisNCT03592056

Hemidiaphragmatic Paralysis With Diluted Continuous Interscalene Plexus Infusions

An observational study of Diaphragmatic Paralysis and Postoperative Pain, run by Clinica las Condes, Chile at 1 site in Chile.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
30 participants
Where
1 siteChile
Study dates
10 Aug 2018to 23 Jul 2019
How long will I take part?
1 Week
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • pregnancy
  • prior surgery in the ipsilateral neck region
  • chronic pain conditions

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Clínica Las Condes

    Santiago, Metropolitan

Other trials in Chile

About this study

Official title: 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).

Keywords
hemidiaphragmatic paralysis, continuous plexus block, interscalene plexus block, diluted local anesthetic infusion, ambulatory regional analgesia, ambulatory continuous nerve block, continuous local anesthetic infusion
Medical subject headings
Respiratory Paralysis, Pain, Postoperative, Acute Pain, Shoulder Pain, Shoulder Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemidiaphragmatic paralysis before discharge

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

    Measured: 24 hours after surgery

Secondary outcomes (18)

  1. Hemidiaphragmatic paralysis after surgery

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

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

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

    boluses of LA administered by the patient controlled infusor in adidiotn to a basal rate.

    Measured: 24 hours after surgery

  3. 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

    Measured: 30 minutes after arrival to PACU

  4. 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

    Measured: 60 minutes after arrival

  5. 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

    Measured: 3 hours after arrival to PACU

  6. 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

    Measured: 6 hours after arrival to PACU

  7. 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

    Measured: 12 hour after arrival to PACU

  8. Level of static pain before discharge

    Level of pain at rest referred by the patient using a numeric rating scale from 0 to 10

    Measured: 24 hours post surgery

  9. 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

    Measured: 48 hours after surgery

  10. 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

    Measured: 72 hours after surgery

  11. intraoperative morphine equivalent consumption

    total amount of morphine equivalent opioid requirement in milligrams

    Measured: intraoperative period

  12. postoperative morphine equivalent consumption

    total amount of morphine equivalent opioid requirement in milligrams

    Measured: 24 hours after surgery

  13. sensory block in PACU

    loss of sensation to cold in lateral deltoid area

    Measured: 30 minutes after arrival to PACU

  14. Motor block in PACU

    paresia or paralysis in operated side, shoulder, arm, forearm or hand

    Measured: 30 minutes after arrival to PACU

  15. sensory block previous to discharge

    loss of sensation to cold in lateral deltoid area

    Measured: 24 hours after surgery

  16. motor block previous to discharge

    paresia or paralysis in operated side shoulder, arm, forearm or hand

    Measured: 24 hours after surgery

  17. 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.

    Measured: 24 hours after surgery

  18. 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.

    Measured: 24 to 72 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2018
  2. Study start10 Aug 2018
  3. Primary completion23 Jul 2019
  4. Study completion23 Jul 2019

Why it stopped: interim analysis proved that protocol intervention had no preventive effect

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (actual)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT03592056
Sponsor's protocol ID
MA012018
Status last verified
Jan 2020
First submitted
6 Jul 2018
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27941477

  • 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.

    PubMed 26216250

  • 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.

    PubMed 19608563

  • 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.

    PubMed 16331304

Questions about this trial

What is this clinical trial studying?

An observational study of Diaphragmatic Paralysis and Postoperative Pain, run by Clinica las Condes, Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: interim analysis proved that protocol intervention had no preventive effect). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemidiaphragmatic paralysis before discharge (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03592056, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in