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Completed

NCT Number: NCT04726280

Respiratory Impact of LA Volume After IS Block

The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHUV (Centre Hospitalier Universitaire Vaudois)

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.

Our prospective randomized controlled trial will include two parallel groups: a group will receive a volume of 20 mls of ropivacaine 0.75%, while the other group will receive a volume of 10 mls.

All participants will have a preoperative ultrasound-guided interscalene brachial plexus with an extrafascial injection of 10 or 20 mls of ropivacaine 0.75%. In both groups, participants will have an examination of the hemidiaphgragm with the ultrasound, before and 30 min after the block. The respiratory function will also be assessed with a bedside spirometer before and after the block, and at 12 and 24 postoperative hours. During surgery all participants will receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 milligram kg^2, iv ketorolac 30 milligrams, and iv acetaminophen 1000 milligrams, according to the current practice in our institution. In the postoperative period, Participants will be prescribed an IV pca of morphine.

Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • arthroscopic surgery of the shoulder
  • ASA class 1 to 3
  • age more than 18 years old

Exclusion criteria

  • patient refusal or inability to understand and/or sign the inform consent
  • contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm
  • chronic alcool abuse
  • opioid drug abuse or under substitution treatment
  • patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
  • patients under chronic corticotherapy
  • patients known for malignant hyperthermia;
  • patients with chronic kidney failure (Glomerular Filtration Rate < 20 ml/min)
  • patients with severe pulmonary disease
  • patients with history of neck surgery or radiotherapy on the operative side;
  • pregnancy

Treatment and study plan

Ropivacaine 0.75% Injectable Solution

Drug

10 ml extrafascial interscalene brachial plexus block

Primary outcomes

  1. Incidence of hemidiaphragmatic paralysis

    Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection

Secondary outcomes

  1. Incidence of hemidiaphragmatic paralysis

    Time frame: at 2 and 24 postoperative hours

  2. Presence of Dyspnea

    Time frame: in phase 1 recovery and at 12 and 24 postoperative

    Verbal question to the patient if he has dyspnea or not

  3. Presence of PONV

    Time frame: in phase 1 recovery and at 12 and 24 postoperative

    Verbal question to the patient if he has dyspnea or not

  4. Presence of Pruritus

    Time frame: in phase 1 recovery and at 12 and 24 postoperative hours

    Verbal question to the patient if he has pruritus or not

  5. Presence of Claude-Bernard-Horner syndrome

    Time frame: in phase 1 recovery and at 12 and 24 postoperative hours

    Examination of the patient

  6. Presence of Dysphonia

    Time frame: in phase 1 recovery and at 12 and 24 postoperative hours

    Verbal question to the patient if he has dysphonia or not

  7. Forced expiratory volume in one second

    Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours

    in liters per second

  8. Forced vital capacity

    Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours

    in liters

  9. Peak expiratory flow

    Time frame: 30 minutes after the interscalene plexus brachial extrafascial injection, and at 2, 12 and 24 postoperative hours

    in liters per second

  10. Installation time of sensory block

    Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection

    in minutes

  11. Installation time of motor block

    Time frame: up to 30 minutes after the interscalene plexus brachial extrafascial injection

    in minutes

  12. Time to first dose of postoperative iv morphine

    Time frame: up to 24 hours postsurgery

    in hours

  13. Pain scores at rest

    Time frame: in phase 1 recovery and at 12 and 24 postoperative hours

    Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain)

  14. Pain scores on movement

    Time frame: in phase 1 recovery and at 12 and 24 postoperative hours

    Numeric pain intensity scale. Pain scores range from zero (no pain) to 10 (worst possible pain).

  15. Cumulative postoperative iv morphine consumption

    Time frame: in phase 1 recovery and at 12 and 24 postoperative hours

    in milligrams

  16. Duration of analgesic block

    Time frame: up to 24 hours postsurgery

    in minutes

  17. Duration of motor block

    Time frame: up to 24 hours postsurgery

    in minutes

  18. Duration of sensory block

    Time frame: up to 24 hours postsurgery

    in minutes

  19. Satisfaction of the participants

    Time frame: at 24 postoperative hours

    Numeric satisfaction intensity scale. Satisfactions range from 0 (totally unsatisfied) to 10 (maximal satisfaction).

Sponsors and collaborators

Lead sponsor

Eric Albrecht

Other

Registry information

Official study title

Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2021
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.