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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Other: Axillary brachial plexus nerve block: loss and return of sensation

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8008
      • Balgrist University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Block failure	Block failure yes or no	Pre-surgery
Amount of pain medication	Amount of pain medication after surgery, measured in mg	Immediately after the surgery up to 2 days
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
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
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

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Hagen Bomberg, Dr.med., Balgrist University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: March 23, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral regional anesthesia; Loss and return of sensation
• Other Study ID Numbers: W1049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No