Determination of the Sensitivity, Specificity & Receiver Operating Characteristic of Nerve Stimulation Receptor as a Decision-making Tool During US Guided PNB

NCT05190302 | Terminated

• 1 other identifier: 21.294
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Although the superiority of ultrasound guidance over neurostimulation (NS) has been demonstrated, it has its limits, namely when used for a deeper block (device limits) or if used by a less experienced operator (ability to recognize structures, to correctly position the needle). In addition, its use has failed to consistently prevent intra-neural injection. The question of the usefulness of NS in addition to ultrasound is therefore still relevant. A great geographical disparity exists in the habits of nerve localization. The reluctance to use NS stems mainly from doubts about its effectiveness. The threshold used to consider that the needle is sufficiently close to the nerve and the one used to exclude an intraneural injection have been disputed in several studies. Another weakness of studies concerning NS since the advent of ultrasound guidance is the impossibility of generalizing the results. All clinical studies were performed in an academic setting, and a large majority of them specify that the blocks were performed by - or supervised by - regional anesthesia experts. The only study that attempted to determine the sensitivity of NS used ultrasound as a gold standard. The choice of the ultrasound position as the gold standard is debatable, since it is dependent of the operator. The clinical success of nerve blocks would be a better standard. No study to date has made it possible to calculate the specificity and sensitivity of NS in addition to ultrasound guidance, and therefore, to obtain the positive and negative predictive values of the technique. Obtaining these values could allow each clinical setting or individual to determine the contribution of NS to their rate of success, as a modest increase in the success rate or a minimal decrease in the risk of neuropathy would be clinically significant. The hypothesis is that the sensitivity and specificity of NS justifies its use in combination with ultrasound guidance in most settings, but that the gain in efficiency varies depending on the context (for example depending on the local success rate). To determine the required sample size to test this hypothesis and plan for a definitive study on the question, the investigators need to know what is the local failure rate (incidence of studied event) and what could be the possible rate of patient enrollment. This preliminary, feasibility study will aim to confirm that the local failure rate is compatible with the 5% rate observed in the literature.

Conditions

Peripheral Nerve Block

Keywords

Neurostimulation; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Ultrasound-guided peripheral nerve block failure rate

  A block will be considered a success if the patient has complete motor and sensory block, no pain or discomfort in the target area requiring the addition of any analgesic agent during surgery. A conversion to unplanned general anesthesia would constitute a failure of the block.

  At the end of the Phase I study, with an estimated duration of 4 months

Secondary Outcomes (6)

• Recruitment rate

  At the end of the Phase I study, with an estimated duration of 4 months

• Recruitment time

  At the end of the Phase I study, with an estimated duration of 4 months

• Completeness of the data collected

  At the end of the Phase I study, with an estimated duration of 4 months

• Reliability of the data collected

  At the end of the Phase I study, with an estimated duration of 4 months

• Incidence of breach in protocol

  At the end of the Phase I study, with an estimated duration of 4 months

Study Arms (1)

Phase I - Patients undergoing regional anesthesia with a block allowing a neurostimulation.

The investigators propose to conduct a single-blind, prospective observational study on all eligible patients undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients, 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.

You may qualify if:

• Patients, 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.

You may not qualify if:

• Contraindications to a peripheral nerve block
• Risk of severe intoxication to local anesthesia
• Peripheral nerve block in an area not allowing neurostimulation due to absence of motor fibers (for example, adductor canal block)
• Patient refusal
• Patient unable to communicate with the health or research team

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H1L 6A1, Canada

Location

Study Officials

• Sébastien Garneau, MD, FRCPC

  Centre Hospitalier de l'Université de Montreal - CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 13, 2022
• Study Start: January 27, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 6, 2023
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)