The general aim of the present study is to identify the minimum local anaesthetic dose (ED95) of mepivacaine in healthy volunteers.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
postoperative pain
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Blockade of the saphenous nerve may be well suited to provide postoperative
analgesia in knee surgery. Several researchers have described the efficacy of
saphenous nerve block to prevent or treat postoperative pain following major
knee surgery,2 however, a great variation in the volume of the local anesthetic
used for this nerve block is reported, and volumes between 10 and 30 mL of
local anesthetic have been described in literature. So far, no clinical trials
have investigated the minimum local anesthetic dose (ED95) of mepivacaine for
ultrasound-guided saphenous nerve block.
Study objective
The general aim of the present study is to identify the minimum local
anaesthetic dose (ED95) of mepivacaine in healthy volunteers.
Study design
This present study is an observational, double blind (volunteer, assessor)
prospective cohort study.
Intervention
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.
Study burden and risks
Blockade of the purely sensory saphenous nerve is achieved under ultrasound
guidance, and consists of a single injection of local anesthetic typically
within 2 cm of skin level as described before at the distal thigh. The risk of
this intervention can safely be described as very low.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age 18-65 years, ASA physical status I-II (healthy).
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51307.018.14 |