AnesthesiaNCT02795598
Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Block With Single or Double Injection Technique
A study testing Single injection supraclavicular nerve block and Double injection supraclavicular nerve block in people with Anesthesia, run by Nova Scotia Health Authority.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Single injection supraclavicular nerve block and Double injection supraclavicular nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With Single or Double Injection Technique
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.
Read the 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
- Being tested
- Single injection supraclavicular nerve block, Double injection supraclavicular nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single injection supraclavicular nerve blockProcedure or surgery
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 nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Double injection supraclavicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic thickening
Ultrasound measurement of diaphragmatic thickening
Measured: Relative change in ultrasound assessment of diaphragmatic thickening (Baseline vs 30 min after supraclavicular block)
Secondary outcomes (9)
Onset time of sensory 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.
Measured: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Onset time of motor 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.
Measured: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Bedside spirometry - forced expiratory volume at one second (FEV1)
Relative changes in forced expiratory volume at one second (FEV1) will be compared
Measured: Relative change in FEV1 (Baseline vs 30 min after supraclavicular block)
Bedside spirometry - forced vital capacity (FVC)
Relative changes in forced vital capacity (FVC) will be compared
Measured: Relative change in FVC (Baseline vs 30 min after supraclavicular block)
Dyspnea
Patient will be asked if they are having shortness of breath.
Measured: 30 minutes after the supraclavicular block
Procedure performance time
Measurement of time taken to perform both types of block
Measured: From the time that the block needle enters skin until it is removed
Incidence of complications
The incidence of complications, including puncturing a vessel, or post-operative sensory or movement problems
Measured: From block performance until 24 hours after block is completed (24 hour follow-up call)
Clinical Efficacy
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.
Measured: At the time of surgery start
Incidence of Hemidiaphragmatic paresis (HDP) by diaphragmatic excursion
Ultrasound measurement of HDP
Measured: Relative change in ultrasound assessment of diaphragmatic excursion (Baseline vs 30 min after supraclavicular block)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Why it stopped: The study protocol changed significantly and a new file was started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kwesi Kwofie, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795598
- Sponsor's protocol ID
- 1021191
- Status last verified
- Jul 2016
- First submitted
- 27 May 2016
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Dysfunction After Ultrasound-guided Supraclavicular Brachial Plexus Block With Single or Double Injection Technique
- ClinicalTrials.gov ID
- NCT02795598
- Acronym / sponsor ID
- 1021191
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study protocol changed significantly and a new file was started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Injection Supraclavicular Block | Active comparator | Procedure: Single injection supraclavicular nerve blockPatients scheduled for surgery distal to the elbow will have an ultrasound guided single injection supraclavicular nerve block for surgical anesthesia. |
| Double Injection Supraclavicular Block | Active comparator | Procedure: Double injection supraclavicular nerve blockPatients scheduled for surgery distal to the elbow will have an ultrasound guided double injection supraclavicular nerve block for surgical anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- Inability to consent to study participation
- Pre-existing neuromuscular disease or severe neurological dysfunction
- Severe coagulopathy
- Severe obstructive or restrictive lung disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single 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. | Procedure or surgery | Single Injection Supraclavicular Block |
| Double 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. | Procedure or surgery | Double Injection Supraclavicular Block |
Primary outcome
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
9 secondary outcomes
Onset time of sensory block
Time frame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Onset time of motor block
Time frame: Baseline, 5, 10, 15, 20, 25, and 30 minutes after block
Bedside spirometry - forced expiratory volume at one second (FEV1)
Time frame: Relative change in FEV1 (Baseline vs 30 min after supraclavicular block)
Bedside spirometry - forced vital capacity (FVC)
Time frame: Relative change in FVC (Baseline vs 30 min after supraclavicular block)
Dyspnea
Time frame: 30 minutes after the supraclavicular block
Procedure performance time
Time frame: From the time that the block needle enters skin until it is removed
Incidence of complications
Time frame: From block performance until 24 hours after block is completed (24 hour follow-up call)
Clinical Efficacy
Time frame: At the time of surgery start
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwesi Kwofie, MD principal investigator
Nova Scotia Health Authority
Questions about this trial
What is this clinical trial studying?
A study testing Single injection supraclavicular nerve block and Double injection supraclavicular nerve block in people with Anesthesia, run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.