The effect of the Popliteal Plexus Block on muscle function of the leg - a scientific trial in healthy volunteers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

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

Trial duration

27 Sep 2023 → 19 Oct 2023

Decision date (initial)

2023-07-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Danish Society of Anaesthesiology and Intensive Care Medicine · Silkeborg Regional Hospital · The Danish Rheumatism Association · Aarhus University

External identifiers

EU CT number

2023-505263-37-00

ClinicalTrials.gov

NCT05464862

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

The aim of this study is to evaluate the effect of the Popliteal Plexus Block (PPB) on motor nerve branches of the sciatic and femoral nerve, when using volumes of 10 ml, 20 ml or 30 ml of local anesthetic.

Secondary objectives 1

1. The effect of the Popliteal Plexus Block on the saphenous nerve.

Conditions and MedDRA coding

Acute post surgical pain after knee surgery

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age >= 18 years old
2. ASA class 1-2 (American Society of Anesthesiologist classification)
3. Ability to give their written informed consent to participating in the study after having fully understood the contents of the study

Exclusion criteria 16

1. Age > 64 years
2. Subjects who cannot cooperate with the study
3. Subjects who cannot understand or speak Danish
4. Subjects with allergy to the medicines used in the study
5. Subjects suffering from alcohol and/or drug abuse – based on the investigator's opinion
6. Pathology or previous major surgery to the lower limb
7. Intake of any analgesics 24 hours prior to baseline measurements
8. BMI > 35
9. Active signs of infection in the cutaneous area of injection
10. Subjects diagnosed with epilepsy, neurologic diseases, severe hypoxia or respiratory depression, hypovolemia, shock, bradycardia or Wolff-Parkinson-Whites syndrome
11. Subjects with a positive pregnancy test (Women < 60 years must demonstrate a negative pregnancy test (25 mIU/ml) prior to inclusion. Pregnancy test is offered at the trial site at the day of treatment. If the woman fulfills one of the following criteria of not being pregnant, a pregnancy test is not required: 1. Menopausal: woman +50 years old and no period for more than 1 year without any other obvious explanation, or if menopause has been confirmed by measuring LH and FSH. 2. Pregnancy is not possible due to use of highly effective birth control, sterilization, living in a homosexual relationship, living in total sexual abstinence, or hysterectomy.
12. Subjects diagnosed with cardiovascular disease or heart failure
13. Subjects diagnosed with partial or complete cardiac block
14. Subjects in daily treatment with class III antiarrhythmics (e.g. amiodarone)
15. Subjects in daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics, as the toxic effects are additive
16. Subjects diagnosed with severe liver disease or reduced kidney function

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Difference between group A, B and C in post block MVIC by ankle plantarflexion, expressed as a percentage of the pre block value
2. Difference between group A, B and C in post block MVIC by ankle dorsiflexion, expressed as a percentage of the pre block value

Secondary endpoints 6

1. Difference between group A, B and C in post block MVIC by knee extension, expressed as a percentage of the pre block value
2. Difference between group A, B and C, in the number of volunteers with affected cMAP post block of the gastrocnemius muscle
3. Difference between group A, B and C, in the number of volunteers with affected cMAP post block of the tibialis anterior muscle.
4. Difference between group A, B and C, in the number of volunteers with affected cMAP post block of the vastus medialis muscle.
5. Difference between group A, B and C, in the number of volunteers with affected cMAP post block of the vastus lateralis muscle.
6. Difference between group A, B and C in the number of volunteers with an affected saphenous nerve post block, evaluated by the sensory test.

Investigational products

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

Test 1

Auxiliary 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

Johan Klovgaard Sorensen

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

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 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