Clinical trial NCT04015284: Intraoperative Pain and Quality of Surgical Block During Shoulder Surgery Assessed by NOL Index
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Shoulder Surgery
Regional Anesthesia Morbidity
Keywords: NOL monitoring
regional anesthesia
interscalene brachial plexus block
shoulder arthroscopy
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups of patients. Randomization into groups SSNP + PCB or ISBPB as per randomization list, for a total of 100 patients.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dose of remifentanil in mcg/kg/h during the surgery period
timeFrame: Intraoperative from incision until wound dressing
Secondary outcomes:
measure: NOL response after surgical incisions (area under curve)
timeFrame: Intraoperative
measure: NOL response after surgical incisions (area under curve)
timeFrame: Intraoperative
measure: Total dose remifentanil in mcg
timeFrame: Intraoperative
measure: Number of remifentanil boluses (n)
timeFrame: Intraoperative
measure: Desflurance consumption in ml
timeFrame: Intraoperative from incision until wound dressing
measure: Time to awakening in minutes
timeFrame: Intraoperative
measure: Time to extubation in minutes
timeFrame: Intraoperative
measure: PACU pain scores on a scale from 0 to 10
timeFrame: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum
measure: Grip strength in mmHg
timeFrame: in PACU e.g. up to 3 hours after surgery maximum
measure: Diaphragmatic paresis induced by the nerve block by ultrasound
timeFrame: 30 minutes after nerve block and before general anesthesia and surgery, in awake patient
measure: Patient dyspnea on a scale from 0 to 10
timeFrame: PACU e.g. up to 3 hours after surgery maximum
measure: Time to readiness for discharge from PACU in minutes
timeFrame: PACU e.g. up to 3 hours after surgery maximum
measure: 24h pain scores on a scale from 0 to 10 at rest
timeFrame: Postoperative at H24, 24 hours after surgery
measure: 48h pain scores on a scale from 0 to 10 at rest
timeFrame: Postoperative at H48, 48 hours after surgery
measure: 24h pain scores on a scale from 0 to 10 during mobilization
timeFrame: Postoperative at H24, 24 hours after surgery
measure: Per os postoperative (after PACU discharge) morphine equivalent consumption in mg at 8, 16, 24, 32, 40, 48 hs postoperatively
timeFrame: Postoperative for 2 days 48 hours after surgery
measure: Duration of motor block in minutes strength
timeFrame: Postoperative for day 1 H24 24hours after surgery
measure: Patient satisfaction on a scale from 0 to 100
timeFrame: Postoperative at 24h, 24 hours after surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal
state: Quebec
Study officials:
affiliation: CIUSSS de l'Est de Montreal
name: Philippe Richebe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: