LASER volunteer trial: Local Anaesthetic Systemic Effect during Regional anaesthesia procedures

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Oslo University Hospital HF

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Oslo University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To prove superior systemic analgesic effect of lidocaine and ropivacaine after a fascial plane block (TAP block) using an electrical experimental pain model on the area of hyperalgesia.

Secondary objectives 5

1. To prove superior systemic analgesic effect of lidocaine and ropivacaine after a fascial plane block (TAP block) on the perception of pain using electrical stimulation as pain model.
2. To prove superior systemic analgesic effect of lidocaine and ropivacaine after a fascial plane block (TAP block) on the perception of pain using cuff pressure algometry as pain model.
3. To correlate local anaesthetic plasma levels with the inhibition of pain and areas of hyperalgesia.
4. To capture a possible effect of systemic local anaesthetic on haemodynamic parameters
5. To capture possible side effect of systemic local anaesthetic

Conditions and MedDRA coding

Acute pain

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant must be 18 to 64 years of age inclusive, at the time of signing the informed consent
2. Participants who are overtly healthy as determined by medical evaluation (medical history, use of medications, subjective physical impairments) prior to participation in the study. Participants must have ASA physical Status Classification 1 or 2.
3. Body weight within the range of 60 to 95 kg (inclusive) and BMI within the range of 18 to 35 kg/m2 (inclusive)
4. Male participants
5. Capable of giving signed informed consent

Exclusion criteria 4

1. Neurologic disease, nerve- or vascular impairment
2. Known coagulopathy
3. Allergic to local anaesthetic agents
4. Skin infection or exanthema at the site for TAP block or the sites involved in sensory testing

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Area of pinprick hyperalgesia induced by electrical stimulation

Secondary endpoints 8

1. Pain intensity induced by electrical stimulation
2. Cuff-pressure pain tolerance threshold
3. Pain detection threshold tested by cuff-pressure algometry
4. Local anaesthetic plasma concentrations
5. Blood pressure
6. Heart rate
7. Subjective experience of LA side effects
8. Report of all adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Oslo University Hospital HF

Sponsor organisation

Oslo University Hospital HF

Address

Taarnbygget, Kirkeveien 166 Kirkeveien 166

City

Oslo

Postcode

0450

Country

Norway

Scientific contact point

Organisation

Oslo University Hospital HF

Contact name

Axel Sauter

Public contact point

Organisation

Oslo University Hospital HF

Contact name

Axel Sauter

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications