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

NCT04015284 | Withdrawn

• 1 other identifier: 2019-1743
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Shoulder Surgery; Regional Anesthesia Morbidity

Keywords

NOL monitoring; regional anesthesia; interscalene brachial plexus block; shoulder arthroscopy

Outcome Measures

Primary Outcomes (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.

  Intraoperative from incision until wound dressing

Secondary Outcomes (18)

• NOL response after surgical incisions (area under curve)

  Intraoperative

• NOL response after surgical incisions (area under curve)

  Intraoperative

• Total dose remifentanil in mcg

  Intraoperative

• Number of remifentanil boluses (n)

  Intraoperative

• Desflurance consumption in ml

  Intraoperative from incision until wound dressing

Study Arms (2)

SSNB + PCB

EXPERIMENTAL

Single 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%.

Procedure: Suprascapular Nerve Block + Posterior Cord Block

ISBPB

ACTIVE COMPARATOR

Single shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL ropivacaine 0.5%.

Procedure: Interscalene Brachial Plexus Block

Interventions

Suprascapular Nerve Block + Posterior Cord Block PROCEDURE

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%.

Also known as: SSNB+PCB

SSNB + PCB

Interscalene Brachial Plexus Block PROCEDURE

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%.

Also known as: ISPB

ISBPB

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

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

Montreal, Quebec, H1T2M4, Canada

Location

Study Officials

• Philippe Richebe, MD, PhD

  CIUSSS de l'Est de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: 2 groups of patients. Randomization into groups SSNP + PCB or ISBPB as per randomization list, for a total of 100 patients.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: July 10, 2019
• Study Start: September 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

CA (1)