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

Anesthesia Clinical Trial

— LRNB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443879
• Other study ID #: W1049
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Balgrist University Hospital
• Contact: Stefani Dossi
• Phone: +41 44 510 73 75
• Email: stefani.dossi[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Outpatients with planed surgery with axillary brachial plexus nerve block

• Informed consent as documented by signature

• Age = 18 years

Exclusion Criteria:

• Patients with a known allergy towards the local anaesthetic

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• Axillary brachial plexus nerve block: loss and return of sensation
Evaluating loss and return of sensation after axillary brachial plexus nerve block

Locations

Country	Name	City	State
Switzerland	Balgrist University Hospital	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

References & 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 Infec — View Citation

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 — View Citation

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-asso — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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 20 — View Citation

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. — View Citation

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.1365-20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Pre-surgery
Secondary	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.	Immediately after the surgery
Secondary	Block failure	Block failure yes or no	Pre-surgery
Secondary	Amount of pain medication	Amount of pain medication after surgery, measured in mg	Immediately after the surgery up to 2 days
Secondary	Prolongation of hospitalization	The patient is expected to be an outpatient. If this does not occur, the days of hospitalization will be recorded.	Immediately after the surgery
Secondary	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.	Immediately after the surgery
Secondary	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.	Immediately after the surgery