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

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ClinicalTrials.gov Identifier: NCT02795598
Recruitment Status : Unknown
Verified July 2016 by Kwesi Kwofie, Nova Scotia Health Authority.
Recruitment status was:  Not yet recruiting
First Posted : June 10, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Kwesi Kwofie, 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.


Condition or disease Intervention/treatment Phase
Anesthesia Procedure: Single injection supraclavicular nerve block Procedure: Double injection supraclavicular nerve block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With Single or Double Injection Technique
Study Start Date : August 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Single injection supraclavicular nerve block

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.


Active Comparator: 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.
Procedure: Double injection supraclavicular nerve block

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.





Primary Outcome Measures :
  1. Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic thickening [ Time Frame: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block) ]
    Ultrasound measurement of diaphragmatic thickening


Secondary Outcome Measures :
  1. Onset time of sensory block [ Time Frame: 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.

  2. Onset time of motor block [ Time Frame: 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.

  3. Bedside spirometry - forced expiratory volume at one second (FEV1) [ Time Frame: Relative change in FEV1 (Baseline vs 30 min after supraclavicular block) ]
    Relative changes in forced expiratory volume at one second (FEV1) will be compared

  4. Bedside spirometry - forced vital capacity (FVC) [ Time Frame: Relative change in FVC (Baseline vs 30 min after supraclavicular block) ]
    Relative changes in forced vital capacity (FVC) will be compared

  5. Dyspnea [ Time Frame: 30 minutes after the supraclavicular block ]
    Patient will be asked if they are having shortness of breath.

  6. Procedure performance time [ Time Frame: From the time that the block needle enters skin until it is removed ]
    Measurement of time taken to perform both types of block

  7. Incidence of complications [ Time Frame: 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

  8. Clinical Efficacy [ Time Frame: 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.

  9. Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic excursion [ Time Frame: Relative change in ultrasound assessment of diaphragmatic excursion (Baseline vs 30 min after supraclavicular block) ]
    Ultrasound measurement of HDP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795598


Contacts
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Contact: Kwesi Kwofie, MD (902) 473-2331

Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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Principal Investigator: Kwesi Kwofie, MD Nova Scotia Health Authority
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Responsible Party: Kwesi Kwofie, Director of Regional Anesthesia and Acute Pain Medicine, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02795598    
Other Study ID Numbers: 1021191
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided