Duration of peripheral nerve blocks in opioid tolerant individuals

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

11 Jun 2024 → 16 Dec 2025

Decision date (initial)

2024-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Center for Planlagt Kirurgi · Dansk Selskab for Anæstesiologi og Intensiv Medicin (DASAIM)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacodynamic, Efficacy

To evaluate the onset time and duration of a radial nerve block in opioid tolerant individuals compared to opioid naive individuals.

Conditions and MedDRA coding

Postoperative pain

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Age > 18 years old
2. ASA 1-3
3. Legally competent and able to give informed consent
4. Chronic pain, defined as persisting pain for more than three months (opioid group)
5. The daily use of 60 mg or more of morphine equivalent for more than a month (opioid group)

Exclusion criteria 14

1. Volunteers who cannot cooperate with the study
2. Volunteers diagnosed with severe liver disease
3. Volunteers diagnosed with severe kidney disease and reduced kidney function (eGFR below 30 mL/min)
4. Volunteers in daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics, as the toxic effects are additive
5. Volunteers in daily treatment with class III antiarrhythmics e.g., amiodarone.
6. Volunteers who cannot understand or speak Danish
7. Volunteers with allergy to the lidocaine or the preservatives used in the study
8. Volunteers suffering from alcohol or drug abuse other than opioids
9. Peripheral neuropathy at the upper limb non-dominant arm
10. Pathology or previous major surgery to the upper limb
11. Active signs of infection in the cutaneous area of injection
12. Pregnancy at the time of the trial
13. Volunteers diagnosed with partial or complete 2nd or 3rd degree atrioventricular heart block without a pacemaker
14. Age > 84 years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The difference between group A and B in duration of sensory nerve block

Secondary endpoints 3

1. The difference between group A and B in onset time of sensory block measured as T0 to T2.
2. The difference between group A and B in motor block onset time measured as T0 to T1.
3. The difference between group A and B in duration of motor nerve block measured as T0 to T3.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation

Region Midtjylland

Address

Falkevej 1/3

City

Silkeborg

Postcode

8600

Country

Denmark

Scientific contact point

Organisation

Region Midtjylland

Contact name

Charlotte Runge

Public contact point

Organisation

Region Midtjylland

Contact name

Charlotte Runge

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

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