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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02170948
• Other study ID #: 13-6795-A
• Status: Terminated
• Phase: N/A
• Start date: April 2014
• Est. completion date: January 4, 2019

Study information

• Verified date: November 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 4, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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