Intraoperative Pain and Quality of Surgical Block During Shoulder Surgery Assessed by NOL Index
- Conditions
- Regional Anesthesia MorbidityShoulder Surgery
- Interventions
- Procedure: Suprascapular Nerve Block + Posterior Cord BlockProcedure: Interscalene Brachial Plexus Block
- Registration Number
- NCT04015284
- Lead Sponsor
- Ciusss de L'Est de l'Île de Montréal
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ASA status 1,2,3.
- Age 18 years or older
- Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSNB + PCB Suprascapular Nerve Block + Posterior Cord Block 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%. ISBPB Interscalene Brachial Plexus Block Single shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL ropivacaine 0.5%.
- Primary Outcome Measures
Name Time Method Dose of remifentanil in mcg/kg/h during the surgery period Intraoperative from incision until wound dressing 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.
- Secondary Outcome Measures
Name Time Method Total dose remifentanil in mcg Intraoperative Total dose of remifentanil in mcg from incision until wound dressing
PACU pain scores on a scale from 0 to 10 From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum PACU pain scores
Grip strength in mmHg in PACU e.g. up to 3 hours after surgery maximum Grip strength before nerve blockade and prior to PACU discharge, as measured in mmHg by a pressure transducer connected to a 1000mL saline bag.
Diaphragmatic paresis induced by the nerve block by ultrasound 30 minutes after nerve block and before general anesthesia and surgery, in awake patient Ipsilateral diaphragmatic excursion 30 minutes after block completion (normal, paradoxical or no movement).
Time to readiness for discharge from PACU in minutes PACU e.g. up to 3 hours after surgery maximum Time to readiness for discharge from PACU = time in minutes to reach an Aldrete score at 9 for discharge
48h pain scores on a scale from 0 to 10 at rest Postoperative at H48, 48 hours after surgery 48h pain scores
24h pain scores on a scale from 0 to 10 during mobilization Postoperative at H24, 24 hours after surgery 24h pain scores during mobilization
Per os postoperative (after PACU discharge) morphine equivalent consumption in mg at 8, 16, 24, 32, 40, 48 hs postoperatively Postoperative for 2 days 48 hours after surgery Per os opioid consumption in mg of equivalent morphine (every 8 hours by nurses or with a diary in patients with same day surgery).
Duration of motor block in minutes strength Postoperative for day 1 H24 24hours after surgery Duration of motor block in minutes, as measured by time to return of normal grip strength.
Patient satisfaction on a scale from 0 to 100 Postoperative at 24h, 24 hours after surgery Patient satisfaction at 24 hours on a scale from 0 to 100.
NOL response after surgical incisions (area under curve) Intraoperative 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).
Number of remifentanil boluses (n) Intraoperative Number of remifentanil boluses administered to the patient from incision until wound dressing
Desflurance consumption in ml Intraoperative from incision until wound dressing Intraoperative consumption of desflurane in mL
Time to awakening in minutes Intraoperative Time to awakening in minutes.
Patient dyspnea on a scale from 0 to 10 PACU e.g. up to 3 hours after surgery maximum Patient dyspnea prior to PACU discharge on a scale from 0 to 10.
24h pain scores on a scale from 0 to 10 at rest Postoperative at H24, 24 hours after surgery 24h pain scores, H24
Time to extubation in minutes Intraoperative Time to extubation in minutes.
Trial Locations
- Locations (1)
Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal
🇨🇦Montréal, Quebec, Canada