Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Block With Single or Double Injection Technique
- Conditions
- Anesthesia
- Registration Number
- NCT02795598
- Lead Sponsor
- Nova Scotia Health Authority
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic thickening Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block) Ultrasound measurement of diaphragmatic thickening
- Secondary Outcome Measures
Name Time Method Onset time of motor block Baseline, 5, 10, 15, 20, 25, and 30 minutes after block Motor blockade of the musculocutaneous, radial, median, and ulnar nerves will be evaluated by elbow flexion, thumb abduction, thumb opposition, and thumb adduction, respectively. Motor blockade will be graded on a 3-point scale: 0 = normal strength, 1 = weakness relative to the contralateral side, and 2 = complete paralysis. A composite score will be created for each time point.
Bedside spirometry - forced vital capacity (FVC) Relative change in FVC (Baseline vs 30 min after supraclavicular block) Relative changes in forced vital capacity (FVC) will be compared
Procedure performance time From the time that the block needle enters skin until it is removed Measurement of time taken to perform both types of block
Clinical Efficacy At the time of surgery start Nerve blocks will be considered clinically efficacious if surgery is able to proceed without the need for additional local anesthesia at the site or need for general anesthesia. Any use of supplemental local or general anesthesia will be considered a block failure.
Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic excursion Relative change in ultrasound assessment of diaphragmatic excursion (Baseline vs 30 min after supraclavicular block) Ultrasound measurement of HDP
Dyspnea 30 minutes after the supraclavicular block Patient will be asked if they are having shortness of breath.
Onset time of sensory block Baseline, 5, 10, 15, 20, 25, and 30 minutes after block Sensation of the terminal peripheral nerves of the upper extremity will be assessed by a single observer blinded to the technique for the musculocutaneous, median, radial, ulnar and the medial antebrachial cutaneous nerves. Sensory assessments will be done using a blunt needle and the response will be assessed on a 3-point scale using the contralateral limb as a control: 0 = normal sensation, 1 = hypoesthesia, and 2 = anesthesia. A composite score will be created for each time point.
Bedside spirometry - forced expiratory volume at one second (FEV1) Relative change in FEV1 (Baseline vs 30 min after supraclavicular block) Relative changes in forced expiratory volume at one second (FEV1) will be compared
Incidence of complications From block performance until 24 hours after block is completed (24 hour follow-up call) The incidence of complications, including puncturing a vessel, or post-operative sensory or movement problems