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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Terminated

CT.gov ID

NCT02170948

Collaborator

(none)

Enrollment

Location

Arms

57.1

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Dexmedetomidine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jan 4, 2019

Actual Study Completion Date :

Jan 4, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Duration of Analgesia [patients will be followed for two weeks]
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

Secondary Outcome Measures

Requirements for pain medications; complications [weekly for up to 2 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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