Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With Single or Double Injection Technique
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic thickening
研究概览
简要总结
The investigators plan to determine the incidence of hemi-diaphragmatic paresis (HDP) with two commonly used techniques of supraclavicular nerve block, the single and double injection techniques.
It is our hypothesis that a double injection peripheral nerve block technique will increase the risk of HDP when compared to a single injection technique.
详细描述
The investigators will perform a prospective, blinded, randomized controlled trial to assess the two methods of supraclavicular block (single and double injection), and the resultant incidence of temporary diaphragm dysfunction, or hemi-diaphragmatic paresis (HDP) will be measured with ultrasound. Patients having forearm or hand surgery will be asked by the attending anesthesiologist if they will agree to be approached by someone from the research team for consent and possible inclusion in the study. This will be done in the anesthesia preoperative assessment clinic, or in the pre-op area on the day of surgery (if a patient was not seen in clinic).
Once consented, all patients in the study will have baseline measurements of their sensation and movement of the arm for surgery, as well as an ultrasound examination of the movement of the diaphragm.
Patients will then be randomized to either the single or double injection supraclavicular nerve block. The blocks will be performed by attending anesthesiologists with experience in regional anesthesia, or by residents and fellows under the direct supervision of such anesthesiologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Patients presenting for unilateral upper extremity surgery below the level of the elbow (the forearm or hand) who are having a regional block for anesthesia
- •Patient must be over 18 years old
- •Weight greater than 50kg
- •English speaking
- •Be available to be contacted by phone on post-operative day 1
- •ASA physical status 1-3
- •BMI under 35 kg/m2
排除标准
- •Inability to consent to study participation
- •Pre-existing neuromuscular disease or severe neurological dysfunction
- •Severe coagulopathy
- •Severe obstructive or restrictive lung disease
- •Pregnancy
- •Prior surgery in the supraclavicular region
- •Allergy to medications used in the study
- •Known diaphragmatic dysfunction of either diaphragm
- •Inability to visualize the diaphragm with ultrasound on the side of the surgical procedure
- •Highly opioid-tolerant patient (>40mg of morphine PO or equivalent per day for >1month)
- •Patient requests a general anesthesia technique
- •Attending anesthesiologist preference for alternate anesthetic technique
- •Surgeon or attending anesthesiologist request for a different anesthesia technique
- •Current involvement in another study
研究组 & 干预措施
Single Injection Supraclavicular Block
Patients scheduled for surgery distal to the elbow will have an ultrasound guided single injection supraclavicular nerve block for surgical anesthesia.
干预措施: Single injection supraclavicular nerve block (Procedure)
Double Injection Supraclavicular Block
Patients scheduled for surgery distal to the elbow will have an ultrasound guided double injection supraclavicular nerve block for surgical anesthesia.
干预措施: Double injection supraclavicular nerve block (Procedure)
结局指标
主要结局
Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic thickening
时间窗: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)
Ultrasound measurement of diaphragmatic thickening
次要结局
- Onset time of motor block(Baseline, 5, 10, 15, 20, 25, and 30 minutes after block)
- Bedside spirometry - forced vital capacity (FVC)(Relative change in FVC (Baseline vs 30 min after supraclavicular block))
- Procedure performance time(From the time that the block needle enters skin until it is removed)
- Clinical Efficacy(At the time of surgery start)
- Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic excursion(Relative change in ultrasound assessment of diaphragmatic excursion (Baseline vs 30 min after supraclavicular block))
- Dyspnea(30 minutes after the supraclavicular block)
- Onset time of sensory block(Baseline, 5, 10, 15, 20, 25, and 30 minutes after block)
- Bedside spirometry - forced expiratory volume at one second (FEV1)(Relative change in FEV1 (Baseline vs 30 min after supraclavicular block))
- Incidence of complications(From block performance until 24 hours after block is completed (24 hour follow-up call))