Does Perineural Dexamethasone Prolong Duration of a Nerve Block?

Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Ropivacaine + dexamethasone; Drug: Ropivacaine + placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Gentofte, Hellerup, Denmark, 2900
      • Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine + dexamethasone; 20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml	Drug: Ropivacaine + dexamethasone; Adductor canal block, single bolus
Placebo Comparator: Ropivacaine + placebo; 20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad	Drug: Ropivacaine + placebo; Adductor canal block, single bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).	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	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed). Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.	0-36 hours
Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.	0-36 hours
Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold	Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.	0-36 hours
Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation	Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values.	0-36 hours

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Pia Jæger, MD, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 27, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Estimate): September 1, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: lower limb; Anesthetics, Local; duration; Adjuvants, Anesthesia; adductor canal block; US-guided peripheral nerve block; Sensation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Ropivacaine
• Other Study ID Numbers: SM2-PJ-14; 2014-004879-23 (EudraCT Number)