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Shoulder SurgeryNCT04015284

Intraoperative Pain and Quality of Surgical Block During Shoulder Surgery Assessed by NOL Index

A study testing Suprascapular Nerve Block + Posterior Cord Block and Interscalene Brachial Plexus Block in people with Shoulder Surgery and Regional Anesthesia Morbidity, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Suprascapular Nerve Block + Posterior Cord Block and Interscalene Brachial Plexus Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
15 Sep 2019to 15 Dec 2019
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA status 1,2,3.
  • Age 18 years or older
  • Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively

Who cannot join

  • Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
  • Coagulation disorders.
  • Patient refusal.
  • Anatomical disorders and/or neuropathic disease.
  • BMI above 40.
  • History of substance abuse.
Show all 11Show fewer
  • Chronic use of psychotropic and/or opioid.
  • History of psychiatric diseases needing treatment.
  • Contraindications to nerve block for shoulder surgery.
  • Allergy to remifentanil or any drug in the study protocol.
  • Failure of nerve block performed in the preoperative block room

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal

    Montreal, Quebec, H1T2M4

Other trials in Canada

About this study

Official title: Intraoperative Pain and Quality of the Surgical Nerve Block During Arthroscopic Shoulder Surgery Assessed by the NOL Index When Comparing the Combined Suprascapular and Posterior Cord Nerve Blocks to the Interscalene Brachial Plexus Block

Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to a posterior cord block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks. This prospective observational study will evaluate the NOL response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and posterior cord blocks or an interscalene block.

Study Design: Prospective, randomized open label non-inferiority trial. Subject Population: Adults scheduled to undergo elective shoulder arthroscopy Sample Size: 100 patients Study Duration: Starts February 2019 - Ends February 2021 - Interim analysis at 50 patients Study Center: Maisonneuve-Rosemont Hospital, CEMTL, Montreal, Quebec, Canada

Read the detailed description

The main hypothesis of this study is that the suprascapular block combined with a posterior cord block is not inferior to the interscalene brachial plexus block in terms of intraoperative analgesia. We postulate that intraoperative opioid requirements will not differ significantly in patients who receive either block.

Our secondary objectives will consist in looking at the differences in intraoperative anesthetic consumption, NOL index alterations, postoperative opioid consumption, pain scores, arm motor block, diaphragmatic paresis, patient satisfaction and time for readiness to discharge from PACU. We hypothesize that these outcomes will be similar in both groups, with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and posterior cord block group.

After having obtained institutional ethics board approval of the study, patients older than 18 years old, scheduled for a first elective shoulder arthroscopy under general anesthesia will be screened in the pre-anesthesia clinic. They will be approached and the whole study procedures will be explained extensively. Interested patients will be invited to sign the consent form (see appendix). Patients will have the right to opt out at any time. The investigators will meet the patients again on the morning of the surgery to address any concerns. After consent, a study number will be allocated to the patient in ascending order.

Two groups will be evaluated:

  • Group A: single shot US-guided suprascapular nerve block with 5 mL ropivacaine 0.5%, then single shot US-guided posterior cord block with 10 ml ropivacaine 0.5%.
  • Group B: single shot US-guided interscalene brachial plexus block with 15 mL ropivacaine 0.5%.

Tests will be done to evaluate the nerve block-induced loss of sensation to ice prior to entering the operating room (OR). Diaphragmatic excursion will be evaluated using an abdominal curvilinear ultrasound probe, and will be classified as being normal, paradoxical or immobile. Normal motion is caudad movement during inspiration. Paradoxical motion is cephalad movement during inspiration.

Once in the operating room, all routine monitors are connected. Moreover, the PMD TM monitor as well as the BIS® monitor are connected to the anesthesia machine and to the patient. Both study monitors are switched on and will record their respective indices continuously for the duration of the anesthesia. General anesthesia will be induced with propofol (1-2 mg/kg IV; Pharmascience Inc, Canada), remifentanil (1 µg/kg IV bolus; Teva, Canada) and rocuronium (0.6-1 mg/kg IV; Sandoz Canada Inc). A bolus of dexamethasone 4mg IV will be administered after induction of general anesthesia.

Patients will also have received oral acetaminophen 1g and celecoxib 400 mg preoperatively. Intubation with an endotracheal tube is performed once the patient is adequately paralyzed (no responses to the TOF stimulation). All drugs are given according to the adjusted body weight of the patient. This is calculated with Robinson's formula: where TBW is total body weight and IBW is ideal body weight (21-22). Immediately after intubation, anesthesia is maintained with desflurane while targeting a BIS value between 45 and 55, and a remifentanil infusion and boluses are used for a NOL below 25. At the end of anesthesia, when the surgeon starts closing the wounds, an IV bolus of hydromorphone 7 mcg/kg of adjusted body weight is administered. The remifentanil infusion and desflurane are discontinued when dressing starts. Emergence and extubation are done in the OR. All times (start skin closure, start dressing, stop desflurane and remifentanil) will be precisely reported in the CRF.

Being tested
Suprascapular Nerve Block + Posterior Cord Block, Interscalene Brachial Plexus Block
Keywords
NOL monitoring, regional anesthesia, interscalene brachial plexus block, shoulder arthroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suprascapular Nerve Block + Posterior Cord BlockProcedure or surgery

    Also called SSNB+PCB

    The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of ropivicaine 0.5%. The posterior cord is readily visualized when performing an infraclavicular brachial plexus block. It is blocked using 10mL of ropivicaine 0.5%.

  • Interscalene Brachial Plexus BlockProcedure or surgery

    Also called ISPB

    The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of ropivacaine 0.5%.

Study groups in NCT04015284
Study groupRoleWhat they receive
SSNB + PCBExperimentalSingle shot US-guided suprascapular nerve block (SSNB) with 5 mL ropivacaine 0.5%, then single shot US-guided posterior cord block (PCB) with 10 ml ropivacaine 0.5%.
Receives: Procedure: Suprascapular Nerve Block + Posterior Cord Block
ISBPBActive comparatorSingle shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL ropivacaine 0.5%.
Receives: Procedure: Interscalene Brachial Plexus Block

What is being measured

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

  1. Dose of remifentanil in mcg/kg/h during the surgery period

    The main criterion will be evaluating the dose of remifentanil per kg per hour of surgery needed intraoperatively to keep a NOL index below the threshold of 25.

    Measured: Intraoperative from incision until wound dressing

Secondary outcomes (18)
  1. NOL response after surgical incisions (area under curve)

    NOL response after surgical incisions 1 (located 2 cm inferior and 1 cm medial to posterolateral corner of acromion) of the shoulder (by calculating the area under the curve of NOL for the 5 minutes following incision 1).

    Measured: Intraoperative

  2. NOL response after surgical incisions (area under curve)

    NOL response after surgical incisions 2 (located slightly inferior to coracoid) of the shoulder (by calculating the area under the curve of NOL for the 5 minutes following incision 1).

    Measured: Intraoperative

  3. Total dose remifentanil in mcg

    Total dose of remifentanil in mcg from incision until wound dressing

    Measured: Intraoperative

  4. Number of remifentanil boluses (n)

    Number of remifentanil boluses administered to the patient from incision until wound dressing

    Measured: Intraoperative

  5. Desflurance consumption in ml

    Intraoperative consumption of desflurane in mL

    Measured: Intraoperative from incision until wound dressing

  6. Time to awakening in minutes

    Time to awakening in minutes.

    Measured: Intraoperative

  7. Time to extubation in minutes

    Time to extubation in minutes.

    Measured: Intraoperative

  8. PACU pain scores on a scale from 0 to 10

    PACU pain scores

    Measured: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum

  9. Grip strength in mmHg

    Grip strength before nerve blockade and prior to PACU discharge, as measured in mmHg by a pressure transducer connected to a 1000mL saline bag.

    Measured: in PACU e.g. up to 3 hours after surgery maximum

  10. Diaphragmatic paresis induced by the nerve block by ultrasound

    Ipsilateral diaphragmatic excursion 30 minutes after block completion (normal, paradoxical or no movement).

    Measured: 30 minutes after nerve block and before general anesthesia and surgery, in awake patient

  11. Patient dyspnea on a scale from 0 to 10

    Patient dyspnea prior to PACU discharge on a scale from 0 to 10.

    Measured: PACU e.g. up to 3 hours after surgery maximum

  12. Time to readiness for discharge from PACU in minutes

    Time to readiness for discharge from PACU = time in minutes to reach an Aldrete score at 9 for discharge

    Measured: PACU e.g. up to 3 hours after surgery maximum

  13. 24h pain scores on a scale from 0 to 10 at rest

    24h pain scores, H24

    Measured: Postoperative at H24, 24 hours after surgery

  14. 48h pain scores on a scale from 0 to 10 at rest

    48h pain scores

    Measured: Postoperative at H48, 48 hours after surgery

  15. 24h pain scores on a scale from 0 to 10 during mobilization

    24h pain scores during mobilization

    Measured: Postoperative at H24, 24 hours after surgery

  16. Per os postoperative (after PACU discharge) morphine equivalent consumption in mg at 8, 16, 24, 32, 40, 48 hs postoperatively

    Per os opioid consumption in mg of equivalent morphine (every 8 hours by nurses or with a diary in patients with same day surgery).

    Measured: Postoperative for 2 days 48 hours after surgery

  17. Duration of motor block in minutes strength

    Duration of motor block in minutes, as measured by time to return of normal grip strength.

    Measured: Postoperative for day 1 H24 24hours after surgery

  18. Patient satisfaction on a scale from 0 to 100

    Patient satisfaction at 24 hours on a scale from 0 to 100.

    Measured: Postoperative at 24h, 24 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 posted10 Jul 2019
  2. Study start15 Sep 2019
  3. Primary completion15 Dec 2019
  4. Study completion15 Dec 2019

Why it stopped: This type of surgery is no longer done at HMR, relocated to other centers

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 groups of patients. Randomization into groups SSNP + PCB or ISBPB as per randomization list, for a total of 100 patients.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04015284
Sponsor's protocol ID
2019-1743
Status last verified
Oct 2021
First submitted
8 Apr 2019
Last updated
8 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Suprascapular Nerve Block + Posterior Cord Block and Interscalene Brachial Plexus Block in people with Shoulder Surgery and Regional Anesthesia Morbidity, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

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 11 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: withdrawn, as of the sponsor's last update on 8 Oct 2021. 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 Canada. 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 withdrawn before enrolling participants, so there are no results.

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?

Dose of remifentanil in mcg/kg/h during the surgery period (time frame: Intraoperative from incision until wound dressing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Oct 2021.

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