AzTrials
AzTrials

AnesthesiaLRNBNCT06443879

Loss and Return of Sensation After Axillary Brachial Plexus Nerve Block - Distally or Proximally

An observational study of Anesthesia, run by Balgrist University Hospital at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Peripheral regional anesthesia is the current gold standard of opioid-sparing perioperative analgesia, especially in shoulder, upper limb, and leg surgery. Axillary brachial plexus nerve block is one possible block for upper limb surgery. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Anesthesia
What is being tested?
Axillary brachial plexus nerve block: loss and return of sensation
How many people
50 participants
Where
1 siteSwitzerland
Study dates
1 Feb 2024to 12 Sep 2024
Phase
Observational
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All outpatients undergoing upper limb surgery with axillary brachial plexus nerve block at Balgrist University Hospital will be eligible to take part in the project.

Who may be able to join

  • Outpatients with planed surgery with axillary brachial plexus nerve block
  • Informed consent as documented by signature
  • Age ≥ 18 years

Who cannot join

  • Patients with a known allergy towards the local anaesthetic

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Balgrist University Hospital

    Zurich, Canton of Zurich, 8008

Other trials in Switzerland

About this study

Peripheral regional anesthesia is the current gold standard of opioid-sparing perioperative analgesia, especially in shoulder, upper limb, and leg surgery. Axillary brachial plexus nerve block is one possible block for upper limb surgery. Loss and return of sensation require time and loss of sensation is supposed to spread from the proximal part to the distal part of the upper limb. Interestingly, until now there is no study about the return of sensation related to the anatomic region.

The investigators hypothesize that the loss and return of sensation after axillary brachial plexus nerve block will first occur in the proximal part of the upper limb and last in the distal part.

Read the detailed description

Peripheral regional anesthesia is the current gold standard of opioid-sparing perioperative analgesia, especially in shoulder, upper limb, and leg surgery.(1-8) Axillary brachial plexus nerve block is one possible block for upper limb surgery.(4, 5, 9) Loss and return of sensation require time. It is known from clinical practice that loss of sensation occurs from the proximal part of the arm to the distal part of the upper limb.

Interestingly, until now there is no study about the return of sensation related to the anatomic region. The investigators hypothesize that return of sensation after axillary brachial plexus nerve block will develop in the same direction like loss of sensation, what means from proximal to the distal part of the upper limb.

Conditions
Anesthesia
Being tested
Axillary brachial plexus nerve block: loss and return of sensation
Keywords
Peripheral regional anesthesia, Loss and return of sensation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary brachial plexus nerve block: loss and return of sensationOther

    Evaluating loss and return of sensation after axillary brachial plexus nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loss of sensation after axillary brachial plexus nerve block

    A questionnaire will be used to record the loss of sensation in the upper limb. Sensation loss is recorded separately for the finger, hand, forearm, elbow, and arm. It will distinguish between initial and complete loss of sensation.

    Measured: Pre-surgery

  2. Return of sensation after axillary brachial plexus nerve block

    A questionnaire will be used to record the return of sensation in the upper limb. Sensation return is recorded separately for the finger, hand, forearm, elbow, and arm. It will distinguish between initial and complete return of sensation.

    Measured: Immediately after the surgery

Secondary outcomes (7)

  1. Pain before

    Pain score (Numeric Rating Scale: 0 to 10) before loss of sensation after the axillary brachial plexus nerve block on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.

    Measured: Pre-surgery

  2. Pain after

    Pain score (Numeric Rating Scale: 0 to 10) after loss of sensation after the axillary brachial plexus nerve block on a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.

    Measured: Immediately after the surgery

  3. Block failure

    Block failure yes or no

    Measured: Pre-surgery

  4. Amount of pain medication

    Amount of pain medication after surgery, measured in mg

    Measured: Immediately after the surgery up to 2 days

  5. Prolongation of hospitalization

    The patient is expected to be an outpatient. If this does not occur, the days of hospitalization will be recorded.

    Measured: Immediately after the surgery

  6. Patients satisfaction with pain therapy

    The patient will be asked to rate their satisfaction with the pain therapy on a scale from 0 to 10, with 0 indicating very dissatisfied and 10 indicating very satisfied.

    Measured: Immediately after the surgery

  7. Satisfaction of medical staff with the execution of the axillary brachial plexus nerve block

    The medical staff will be asked to rate their satisfaction with the execution of the axillary brachial plexus nerve block on a scale from 0 to 10, with 0 indicating very dissatisfied and 10 indicating very satisfied.

    Measured: Immediately after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start1 Feb 2024
  3. Primary completion12 Sep 2024
  4. Study completion12 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443879
Sponsor's protocol ID
W1049
Acronym
LRNB
Status last verified
Sep 2024
First submitted
23 Mar 2024
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bomberg H, Bayer I, Wagenpfeil S, Kessler P, Wulf H, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Spies C, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Sessler DI, Volk T, Raddatz A. Prolonged Catheter Use and Infection in Regional Anesthesia: A Retrospective Registry Analysis. Anesthesiology. 2018 Apr;128(4):764-773. doi: 10.1097/ALN.0000000000002105.

    PubMed 29420315

  • Bomberg H, Huth A, Wagenpfeil S, Kessler P, Wulf H, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Spies C, Kutter B, Winckelmann J, Burgard G, Vicent O, Koch T, Sessler DI, Volk T, Raddatz A. Psoas Versus Femoral Blocks: A Registry Analysis of Risks and Benefits. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):719-724. doi: 10.1097/AAP.0000000000000643.

    PubMed 28806216

  • Bomberg H, Kubulus C, List F, Albert N, Schmitt K, Graber S, Kessler P, Steinfeldt T, Standl T, Gottschalk A, Wirtz SP, Burgard G, Geiger P, Spies CD, Volk T; German Network for Regional Anaesthesia Investigators. Diabetes: a risk factor for catheter-associated infections. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):16-21. doi: 10.1097/AAP.0000000000000196.

    PubMed 25474624

  • Bomberg H, Lorenzana D, Aguirre J, Eichenberger U. [Peripheral Regional Anaesthesia for Perioperative Analgesia]. Praxis (Bern 1994). 2021 Aug;110(10):579-589. doi: 10.1024/1661-8157/a003682. German.

    PubMed 34344186

  • Bomberg H, Wetjen L, Wagenpfeil S, Schope J, Kessler P, Wulf H, Wiesmann T, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Kutter B, Winckelmann J, Liebl-Biereige S, Meissner W, Vicent O, Koch T, Burkle H, Sessler DI, Volk T. Risks and Benefits of Ultrasound, Nerve Stimulation, and Their Combination for Guiding Peripheral Nerve Blocks: A Retrospective Registry Analysis. Anesth Analg. 2018 Oct;127(4):1035-1043. doi: 10.1213/ANE.0000000000003480.

    PubMed 29863605

  • Donauer K, Bomberg H, Wagenpfeil S, Volk T, Meissner W, Wolf A. Regional vs. General Anesthesia for Total Knee and Hip Replacement: An Analysis of Postoperative Pain Perception from the International PAIN OUT Registry. Pain Pract. 2018 Nov;18(8):1036-1047. doi: 10.1111/papr.12708. Epub 2018 Jun 25.

    PubMed 29758587

  • Gabriel RA, Swisher MW, Sztain JF, Furnish TJ, Ilfeld BM, Said ET. State of the art opioid-sparing strategies for post-operative pain in adult surgical patients. Expert Opin Pharmacother. 2019 Jun;20(8):949-961. doi: 10.1080/14656566.2019.1583743. Epub 2019 Feb 27.

    PubMed 30810425

  • Luedi MM, Upadek V, Vogt AP, Steinfeldt T, Eichenberger U, Sauter AR. A Swiss nationwide survey shows that dual guidance is the preferred approach for peripheral nerve blocks. Sci Rep. 2019 Jun 24;9(1):9178. doi: 10.1038/s41598-019-45700-3.

    PubMed 31235760

  • Marhofer P, Eichenberger U, Stockli S, Huber G, Kapral S, Curatolo M, Kettner S. Ultrasonographic guided axillary plexus blocks with low volumes of local anaesthetics: a crossover volunteer study. Anaesthesia. 2010 Mar;65(3):266-71. doi: 10.1111/j.1365-2044.2010.06247.x. Epub 2010 Jan 29.

    PubMed 20121770

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Balgrist University Hospital at 1 site in Switzerland.

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 3 inclusion and 1 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Loss of sensation after axillary brachial plexus nerve block (time frame: Pre-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06443879, which also lists 9 linked publications.

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 1 Nov 2024.

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