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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Dose of remifentanil in mcg/kg/h during the surgery period
研究概览
简要总结
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
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA status 1,2,
- •Age 18 years or older
- •Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively
排除标准
- •Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
- •Coagulation disorders.
- •Patient refusal.
- •Anatomical disorders and/or neuropathic disease.
- •BMI above
- •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
结局指标
主要结局
Dose of remifentanil in mcg/kg/h during the surgery period
时间窗: 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.
次要结局
- Number of remifentanil boluses (n)(Intraoperative)
- Desflurance consumption in ml(Intraoperative from incision until wound dressing)
- Time to awakening in minutes(Intraoperative)
- Patient dyspnea on a scale from 0 to 10(PACU e.g. up to 3 hours after surgery maximum)
- 24h pain scores on a scale from 0 to 10 at rest(Postoperative at H24, 24 hours after surgery)
- Total dose remifentanil in mcg(Intraoperative)
- 48h pain scores on a scale from 0 to 10 at rest(Postoperative at H48, 48 hours after surgery)
- Time to extubation in minutes(Intraoperative)
- Time to readiness for discharge from PACU in minutes(PACU e.g. up to 3 hours after surgery maximum)
- 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)
- Grip strength in mmHg(in PACU e.g. up to 3 hours after surgery maximum)
- Diaphragmatic paresis induced by the nerve block by ultrasound(30 minutes after nerve block and before general anesthesia and surgery, in awake patient)
- 24h pain scores on a scale from 0 to 10 during mobilization(Postoperative at H24, 24 hours after surgery)
- 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)
- Duration of motor block in minutes strength(Postoperative for day 1 H24 24hours after surgery)
- Patient satisfaction on a scale from 0 to 100(Postoperative at 24h, 24 hours after surgery)
- NOL response after surgical incisions (area under curve)(Intraoperative)
研究者
Philippe Richebe
MD, PhD, Professor
Ciusss de L'Est de l'Île de Montréal