Clinical trial NCT02795598: Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Block With Single or Double Injection Technique
Official title: Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With Single or Double Injection Technique
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic thickening
timeFrame: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)
Secondary outcomes:
measure: Onset time of sensory block
timeFrame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
measure: Onset time of motor block
timeFrame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
measure: Bedside spirometry - forced expiratory volume at one second (FEV1)
timeFrame: Relative change in FEV1 (Baseline vs 30 min after supraclavicular block)
measure: Bedside spirometry - forced vital capacity (FVC)
timeFrame: Relative change in FVC (Baseline vs 30 min after supraclavicular block)
measure: Dyspnea
timeFrame: 30 minutes after the supraclavicular block
measure: Procedure performance time
timeFrame: From the time that the block needle enters skin until it is removed
measure: Incidence of complications
timeFrame: From block performance until 24 hours after block is completed (24 hour follow-up call)
measure: Clinical Efficacy
timeFrame: At the time of surgery start
measure: Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic excursion
timeFrame: Relative change in ultrasound assessment of diaphragmatic excursion (Baseline vs 30 min after supraclavicular block)
Other outcomes:
Locations:
Study officials:
affiliation: Nova Scotia Health Authority
name: Kwesi Kwofie, MD
role: PRINCIPAL_INVESTIGATOR
References: