NCT02351804

Brief Summary

The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks. The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 healthy-volunteers

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2 healthy-volunteers

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

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

28 days

First QC Date

January 27, 2015

Last Update Submit

August 31, 2015

Conditions

Healthy Volunteers

Keywords

US-guided peripheral nerve blockAnesthetics, LocaldurationSensationadductor canal blocklower limbAdjuvants, Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab

    Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.

    0-36 hours

Secondary Outcomes (5)

  • Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick

    0-36 hours

  • Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test

    0-36 hours

  • Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold

    0-36 hours

  • Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold

    0-36 hours

  • Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation

    0-36 hours

Study Arms (2)

Ropivacaine + dexamethasone

EXPERIMENTAL

20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml

Drug: Ropivacaine + dexamethasone

Ropivacaine + placebo

PLACEBO COMPARATOR

20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad

Drug: Ropivacaine + placebo

Interventions

Ropivacaine + dexamethasoneDRUG

Adductor canal block, single bolus

Ropivacaine + dexamethasone
Ropivacaine + placeboDRUG

Adductor canal block, single bolus

Ropivacaine + placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists class 1
  • Body Mass Index 18-30

You may not qualify if:

  • Allergy to study medication
  • Earlier trauma or surgery to lower limb
  • Diabetes Mellitus
  • Alcohol or drug abuse
  • Daily intake of opioids or steroids last 4 weeks
  • Daily intake of any analgesics last 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Gentofte Municipality, Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

RopivacaineDexamethasone

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Pia Jæger, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

DK(1)