ULTRASOUND-GUIDED SAPHENOUS NERVE BLOCK: A DOSE-FINDING STUDY IN HEALTHY VOLUNTEERS

ULTRASOUND-GUIDED SAPHENOUS NERVE BLOCK: A DOSE-FINDING STUDY IN HEALTHY VOLUNTEERS - DFSaph

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42255

Enrollment

Registered

2015-01-05

Start date

2015-02-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain nerve blockade postoperative pain

Interventions

Saphenous (mid thigh) nerve block: patients will receive a distal ultrasound-guided saphenous nerve block. The block is performed using an amount of mepivacaine 2% dictated by the Dixon model.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-65 years, ASA physical status I-II (healthy).

Exclusion criteria

Exclusion criteria: allergy against local anesthetics, contraindication for saphenous nerve block (infection at injection site, local pathology), ingestion of any pain medication within the past 24 hours, pregnancy or breastfeeding status.

Design outcomes

Primary

Measure	Time frame
The primary objective of the present study is to determine the ED95 of mepivacaine 2% to elicit saphenous nerve blockade, tested dichotomous (yes/no) by loss of sensation to pinprick at all of the following locations: - the skin over the apex of the Patella, - the skin of the medial aspect of the medial facet of the tibial plateau and - the skin over the medial ankle.	—

Secondary

Measure	Time frame
Secondary aims are to evaluate the influence of volume on duration of sensory blockade, on the extent of potential motor blockade, block onset and block offset, and maximum spread of sensory block on the skin surface.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)