NCT03326609

Brief Summary

Background: Local anesthetic (LA) concentration and nerve block duration is sparsely described in a heterogenic study mass. Aim: To investigate the effect of LA concentration on peripheral nerve block duration in healthy volunteers. Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose. Primary endpoint: Sensory nerve block defined by insensitivity towards cold.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

October 4, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2018

Completed
Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

September 29, 2017

Last Update Submit

January 5, 2018

Conditions

Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Duration of sensory nerve block

    Insensitivity towards cold. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.

    1-24 hours

Secondary Outcomes (1)

  • Duration of motor nerve block

    1-24 hours

Other Outcomes (5)

  • Length of neural exposure to local anesthetic

    10 minutes

  • Onset of sensory nerve block

    10-180 minutes

  • Onset of motor nerve block

    10-180 minutes

  • +2 more other outcomes

Study Arms (5)

Volume: 2.5 mL

EXPERIMENTAL

Perineural injection of ropivacaine 10 mg, 2.5 mL. Concentration: Ropivacaine 4 mg/mL.

Drug: Ropivacaine

Volume: 5 mL

EXPERIMENTAL

Perineural injection of ropivacaine 10 mg, 5 mL. Concentration: Ropivacaine 2 mg/mL

Drug: Ropivacaine

Volume: 10 mL

EXPERIMENTAL

Perineural injection of ropivacaine 10 mg, 10 mL Concentration: Ropivacaine 1 mg/mL

Drug: Ropivacaine

Volume: 15 mL

EXPERIMENTAL

Perineural injection of ropivacaine 10 mg, 15mL Concentration: Ropivacaine 0.67 mg/mL

Drug: Ropivacaine

Volume: 20 mL

EXPERIMENTAL

Perineural injection of ropivacaine 10 mg, 20mL Concentration: Ropivacaine 0.5 mg/mL

Drug: Ropivacaine

Interventions

RopivacaineDRUG

Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h)

Also known as: Isotonic saline (natriumchloride)
Volume: 10 mLVolume: 15 mLVolume: 2.5 mLVolume: 20 mLVolume: 5 mL

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female from and above 18 years of age
  • ASA classification ≤ II

You may not qualify if:

  • BMI below 18 kg/m2
  • Former surgery to the lower extremity in which intervention is planned and surgery which may have caused neural damage to the common peroneal nerve/affected the sensory distribution area of the common peroneal nerve
  • Peripheral nerve disease
  • Allergy to LA
  • Pregnancy or breastfeeding
  • Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study
  • Habitual use of any kind of analgesic treatment
  • Anatomic abnormalities preventing successful US-guided peripheral nerve catheter insertion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjællands Hospital

Hillerød, Danmark, 3400, Denmark

Location

Related Publications (1)

  • Christiansen CB, Madsen MH, Molleskov E, Rothe C, Lundstrom LH, Lange KHW. The effect of ropivacaine concentration on common peroneal nerve block duration using a fixed dose: A randomised, double-blind trial in healthy volunteers. Eur J Anaesthesiol. 2020 Apr;37(4):316-322. doi: 10.1097/EJA.0000000000001112.

    PMID: 31789898DERIVED

MeSH Terms

Interventions

RopivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Claus B Christiansen, MD

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 31, 2017

Study Start

October 4, 2017

Primary Completion

December 8, 2017

Study Completion

January 5, 2018

Last Updated

January 8, 2018

Record last verified: 2018-01

Locations

DK(1)