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

NCT ID: NCT02795598

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-06-01

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Single injection supraclavicular nerve block

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Double injection supraclavicular nerve block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kwesi Kwofie, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Other Identifiers

1021191

Identifier Type: -

Identifier Source: org_study_id