CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Ropivacaine Injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03138668
NCT03138668Phase 2Completed
CompareCT.gov

The Influence of Different Doses of Local Anesthetic on the Distribution of Anesthesia of the Lateral Femoral Cutaneous Nerve - a Randomized, Blinded, Paired Study of Healthy Individuals

Zealand University Hospital·interventional·Posted May 3, 2017·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating Ropivacaine Injection for Nerve Block and 5 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate and describe the anatomical differences in distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in THA (Total Hip Arthroplasty). Furthermore, we examine any loss of motor function in Musculus Quadriceps due to posible involvement of the Femoral Nerve. This trial will be conducted in healthy volunteers, as a blinded, randomized, paired trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNerve Block, Anesthesia, Local, Pain, Postoperative, Anatomical Distribution, Nervus Cutaneous Femoris Lateralis, Lateral Femoral Cutaneous Nerve
CountriesDenmark
CollaboratorsNaestved Hospital

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 3, 2017
Enrollment StartMay 19, 2017
Primary CompletionJun 9, 2017
TodayJul 2, 2026
Enrollment to primary: 20 daysPosted 9.2 years ago

Interventions

Ropivacaine Injectiondrug

All 20 study participants will receive both treatment "Low dose Ropivacaine" and "High dose Ropivacaine" in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment "Low dose Ropivacaine" and "High dose Ropivacaine" will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment "Low dose Ropivacaine" in the right lower extremity, treatment "High dose Ropivacaine" will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.

Ropivacaine Injectiondrug

All 20 study participants will receive both treatment "Low dose Ropivacaine" and "High dose Ropivacaine" in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment "Low dose Ropivacaine" and "High dose Ropivacaine" will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment "Low dose Ropivacaine" in the right lower extremity, treatment "High dose Ropivacaine" will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.