Loss and Return of Sensation After Axillary Brachial Plexus Nerve Block - Distally or Proximally
LRNB
1 other identifier
observational
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 23, 2024
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2024
CompletedNovember 1, 2024
September 1, 2024
7 months
March 23, 2024
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Pre-surgery
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.
Immediately after the surgery
Secondary Outcomes (7)
Pain before
Pre-surgery
Pain after
Immediately after the surgery
Block failure
Pre-surgery
Amount of pain medication
Immediately after the surgery up to 2 days
Prolongation of hospitalization
Immediately after the surgery
- +2 more secondary outcomes
Interventions
Evaluating loss and return of sensation after axillary brachial plexus nerve block
Eligibility Criteria
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.
You may qualify if:
- Outpatients with planed surgery with axillary brachial plexus nerve block
- Informed consent as documented by signature
- Age ≥ 18 years
You may not qualify if:
- Patients with a known allergy towards the local anaesthetic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Balgrist University Hospital
Zurich, Canton of Zurich, 8008, Switzerland
Related Publications (9)
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.
PMID: 29420315BACKGROUNDBomberg 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.
PMID: 28806216BACKGROUNDBomberg 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.
PMID: 25474624BACKGROUNDBomberg 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.
PMID: 34344186BACKGROUNDBomberg 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.
PMID: 29863605BACKGROUNDDonauer 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.
PMID: 29758587BACKGROUNDGabriel 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.
PMID: 30810425BACKGROUNDLuedi 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.
PMID: 31235760BACKGROUNDMarhofer 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.
PMID: 20121770BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Hagen Bomberg, Dr.med.
Balgrist University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2024
First Posted
June 5, 2024
Study Start
February 1, 2024
Primary Completion
September 12, 2024
Study Completion
September 12, 2024
Last Updated
November 1, 2024
Record last verified: 2024-09