Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02795598

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

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Nova Scotia Health Authority · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESingle injection supraclavicular nerve blockThe 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.
PROCEDUREDouble injection supraclavicular nerve blockThe 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.

Timeline

Start date
2016-08-01
Primary completion
2018-06-01
Completion
2018-06-01
First posted
2016-06-10
Last updated
2022-11-15

Source: ClinicalTrials.gov record NCT02795598. Inclusion in this directory is not an endorsement.