Does Perineural Clonidine Prolong Duration of a Nerve Block?

NCT02444559 | Completed Phase 2 DMC

• 2 other identifiers: SM1-JH-142014-005640-18
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to investigate if clonidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that clonidine/dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

• Difference in duration of sensory block between clonidine 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) Time for sleep will be provided.

  0-36 hours

Secondary Outcomes (5)

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

  0-36 hours

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

  0-36 hours

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

  0-36 hours

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

  0-36 hour

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

  0-36 hours

Study Arms (2)

Ropivacaine+Clonidine

EXPERIMENTAL

Adductor Canal Block Ropivacaine 20ml 5mg/ml+ Clonidine 150ug

Drug: Ropivacaine 20ml 5mg/ml+ Clonidine 150ug

Ropivacaine+Placebo

PLACEBO COMPARATOR

Adductor Canal Block Ropivacaine 20ml 5mg/ml+ saline

Drug: Ropivacaine 20ml 5mg/ml+ Placebo

Interventions

Ropivacaine 20ml 5mg/ml+ Clonidine 150ug DRUG

Ropivacaine+Clonidine

Ropivacaine 20ml 5mg/ml+ Placebo DRUG

Ropivacaine+Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 Heart block Sick sinus node.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Anesthesiology Koege Hospital

Koege, 4600, Denmark

Location

MeSH Terms

Interventions

Ropivacaine; Clonidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jakob H Andersen, MD

  Department of Anesthesiology Koege Hospital

  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: Anesthesiologist, Staff specialist

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

DK (1)