Comparison Between Interscalene and Combined Costoclavicular-suprascapular Blocks for Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- naluphine consumption postoperative
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 costoclavicular 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 patient response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and costoclavicular 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: 50 patients Study Duration: Starts February 2020 - Ends February 2021 - Interim analysis at 30 patients Study Center: Assuit university hospital
详细描述
The main hypothesis of this study is that the suprascapular block combined with a costoclavicular block is not inferior to the interscalene brachial plexus block in terms of postoperative analgesia. Inverstigators postulate that postoperative pain score will not differ significantly in patients who receive either block.
secondary objectives will consist in looking at the differences in intraoperative anesthetic consumption, postoperative opioid consumption, arm motor block, diaphragmatic paresis, patient satisfaction and time for readiness to discharge from PACU. investigators 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 costoclavicular 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. patients will be approached and the whole study procedures will be explained extensively. Interested patients will be invited to sign the consent form .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 bupivacaine 0.5%, then single shot US-guided costoclavicular block with 10 ml bupivacaine 0.5%.
- Group B: single shot US-guided interscalene brachial plexus block with 15 mL bupivacaine 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 fentanil or any drug in the study protocol.
- •Failure of nerve block
结局指标
主要结局
naluphine consumption postoperative
时间窗: 2 hours postoperative
use of naluphine for postoperative analgesia in mg by asking PACU nurse questionnaire
pain scores on a scale from 0 to 10
时间窗: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum
PACU pain score from 1 to 10 which 1 indicate no pain and 10 maximum pain.
次要结局
- Patient dyspnea on a scale from 0 to 10 in dyspnea scale(PACU e.g. up to 3 hours after surgery maximum)
- Total dose fentanil in mcg(Intraoperative)
- Duration of motor block in minutes strength(Postoperative for day 1 H24 24hours after surgery)
- TIME OF 1ST RESCUE ANALGESIC(24 hour postoperative)
- Time to extubation in minutes(Intraoperative)
- Time to awakening in minutes(Intraoperative)
- 24h pain scores on a scale from 0 to 10 at rest (NPS)(Postoperative at H24, 24 hours after surgery)
研究者
mohamed talaat mohamed mohamed
assistant lecturer
Assiut University