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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Shoulder Surgery Regional Anesthesia Morbidity | Procedure: Suprascapular Nerve Block + Posterior Cord Block Procedure: Interscalene Brachial Plexus Block | Not Applicable |
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:
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| 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 |
| Estimated Study Start Date : | September 15, 2019 |
| Estimated Primary Completion Date : | February 15, 2022 |
| Estimated Study Completion Date : | March 15, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: SSNB + PCB
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%.
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Procedure: Suprascapular Nerve Block + Posterior Cord Block
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%.
Other Name: SSNB+PCB
|
|
Active Comparator: ISBPB
Single shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL ropivacaine 0.5%.
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Procedure: Interscalene Brachial Plexus Block
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%.
Other Name: ISPB
|
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Philippe Richebe, MD, PhD | 514-743-6558 | philippe.richebe@umontreal.ca |
| Canada, Quebec | |
| Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal | |
| Montréal, Quebec, Canada, H1T2M4 | |
| Contact: Philippe Richebe, MD, PhD 514-743-6558 philippe.richebe@umontreal.ca | |
| Principal Investigator: | Philippe Richebe, MD, PhD | CIUSSS de l'Est de Montreal |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 8, 2019 | ||||
| First Posted Date ICMJE | July 10, 2019 | ||||
| Last Update Posted Date | July 10, 2019 | ||||
| Estimated Study Start Date ICMJE | September 15, 2019 | ||||
| Estimated Primary Completion Date | February 15, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Dose of remifentanil in mcg/kg/h during the surgery period [ Time Frame: 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intraoperative Pain and Quality of Surgical Block During Shoulder Surgery Assessed by NOL Index | ||||
| Official Title ICMJE | 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 | ||||
| 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 |
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | March 15, 2022 | ||||
| Estimated Primary Completion Date | February 15, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04015284 | ||||
| Other Study ID Numbers ICMJE | 2019-1743 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Philippe Richebe, Ciusss de L'Est de l'Île de Montréal | ||||
| Study Sponsor ICMJE | Ciusss de L'Est de l'Île de Montréal | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Ciusss de L'Est de l'Île de Montréal | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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