Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Block With Single or Double Injection Technique

NCT02795598 | Withdrawn

• 1 other identifier: 1021191
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic thickening

  Ultrasound measurement of diaphragmatic thickening

  Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)

Secondary Outcomes (9)

• Onset time of sensory block

  Baseline, 5, 10, 15, 20, 25, and 30 minutes after block

• Onset time of motor 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)

• Bedside spirometry - forced vital capacity (FVC)

  Relative change in FVC (Baseline vs 30 min after supraclavicular block)

• Dyspnea

  30 minutes after the supraclavicular block

Study Arms (2)

Single Injection Supraclavicular Block

ACTIVE COMPARATOR

Patients scheduled for surgery distal to the elbow will have an ultrasound guided single injection supraclavicular nerve block for surgical anesthesia.

Procedure: Single injection supraclavicular nerve block

Double Injection Supraclavicular Block

ACTIVE COMPARATOR

Patients scheduled for surgery distal to the elbow will have an ultrasound guided double injection supraclavicular nerve block for surgical anesthesia.

Procedure: Double injection supraclavicular nerve block

Interventions

Single injection supraclavicular nerve block PROCEDURE

The ultrasound probe will be applied in a sterile fashion in the supraclavicular fossa to obtain a short-axis view of the subclavian artery. A 22G, 50mm Echogenic Stimuplex needle will be advanced in-plane with respect to the image, and the needle tip will be advanced to the junction of the first rib and subclavian artery. Ultrasound cineloops will be kept of all nerve block procedures. 30 milliliters of mepivacaine 1.5% will be injected incrementally in 5ml boluses at this location looking for spread of local anesthetic under and medial to the subclavian artery. The needle may be slightly repositioned to improve the distribution of the injectate at the discretion of the attending anesthesiologist.

Single Injection Supraclavicular Block

Double injection supraclavicular nerve block PROCEDURE

The ultrasound probe will be applied in a sterile fashion in the supraclavicular fossa to obtain a short-axis view of the subclavian artery. A 22G, 50mm Echogenic Stimuplex needle will be advanced in-plane with respect to the image, and the needle tip will be advanced to the junction of the first rib and subclavian artery. Ultrasound cineloops will be kept of all nerve block procedures. 15 milliliters of mepivacaine 1.5% will be injected incrementally at the same, above-mentioned location. The needle will then be redirected to the superolateral aspect of the brachial plexus, and an additional 15ml will be injected here. Again, the needle may slightly repositioned at the discretion of the attending anesthesiologist in order to obtain adequate spread.

Double Injection Supraclavicular Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Officials

• Kwesi Kwofie, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 10, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 15, 2022

Record last verified: 2016-07