The Effectiveness of the Addition of Dexmedetomidine to Analgesia for Ankle Surgery.

The Analgesic Efficacy of Dexmedetomidine as a Local Anesthetic Adjunct in Ankle Blocks for Forefoot Surgery. A Dose Ranging Study.

Forefoot surgeries involve a relatively short operation usually completed in 1 - 1½ hours, with patients generally being allowed to go home on the same day. Despite this, post-surgery pain is often severe and a delay in the discharge of patients due to difficulty with pain control after the surgery is common.

Performing nerve blocks in association with sedation is the preferred way to provide pain relief and offers important benefits for foot surgeries. With nerve blocks, the requirement for oral painkillers and their associated side effects is reduced. Increasing the duration of local anesthetic action is helpful as it increases the time of pain relief, allowing for a smoother transition to oral pain medications, earlier discharge, and faster recovery.

Recently, Precedex has been considered for its usefulness in prolonging the pain relief produced by nerve blocks. The identified benefits of this particular use include reducing post-surgical pain medications requirements, reducing the incidence of nausea and vomiting, reducing the incidence of sedation from such medication, and diminishing the incidence of respiratory depression (inadequate breathing). Two small studies have also shown that adding dexmedetomidine to nerve block solution results in prolonging pain relief.

The purpose of the study is to examine several doses of dexmedetomidine combined with local anesthetic drugs and determine the best combination for prolonging pain relief, while minimizing potential side effects.

Study Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English Speaking
• American Society of Anesthesiologists (ASA) I-III patients
• Ages 18-65
• Body Mass Index (BMI) ≤ 38 kg/m2

Exclusion Criteria:

• Preexisting neurological deficits or peripheral neuropathy in the distribution of the sciatic or femoral nerves
• Known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
• Baseline line heart rate < 60 Beats Per Minute (BPM) or baseline systolic blood pressure < 100 mm Hg
• Medications that reduce heart rate
• Known liver or renal dysfunction or existing diseases affecting these organs
• Local infection
• Contraindication to regional anesthesia
• Chronic pain disorders
• History of use of over 30mg oxycodone or equivalent per day
• Contraindication to a component of multi-modal analgesia
• Allergy to local anesthetics or dexmedetomidine
• History of significant psychiatric conditions that may affect patient assessment
• Pregnancy
• Inability to provide informed consent
• Patient refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dex 0.5; Ropivacaine and Lidocaine plus Dexmedetomidine (0.5mg/kg) plus Normal Saline	Drug: Dexmedetomidine; An anesthetic concoction of 2% Lidocaine, 1% Ropivacaine, and Dexmedetomidine diluted solution will be provided via a series of anesthetic injections related to the ankle block procedure; Other Names: Precedex
Experimental: Dex 1.0; Ropivacaine and Lidocaine plus Dexmedetomidine (1.0mg/kg) plus Normal Saline	Drug: Dexmedetomidine; An anesthetic concoction of 2% Lidocaine, 1% Ropivacaine, and Dexmedetomidine diluted solution will be provided via a series of anesthetic injections related to the ankle block procedure; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Analgesia	Patients will be asked about the duration of their analgesia by asking when they first felt pain at the surgical site. Patients will be asked prior to discharge, and routinely during specified phone calls until analgesia wear off	patients will be followed for two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Requirements for pain medications; complications	Patients will be called at 24 hours, 7 days and 14 days and asked to describe their pain levels, the requirements for pain medication, and any complications that may have arisen post-operatively.	weekly for up to 2 weeks

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 4, 2019
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: dexmedetomidine; nerve block; ultrasound-guided regional anesthesia; duration; ankle surgery; Precedex; forefoot surgery; ankle block; anesthetic duration following ankle block for forefoot surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 13-6795-A