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

NCT02170948 | Terminated

• 1 other identifier: 13-6795-A
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

ultrasound-guided regional anesthesia; nerve block; ankle block; dexmedetomidine; Precedex; ankle surgery; forefoot surgery; duration; anesthetic duration following ankle block for forefoot surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Requirements for pain medications; complications

  weekly for up to 2 weeks

Study Arms (2)

Dex 0.5

EXPERIMENTAL

Ropivacaine and Lidocaine plus Dexmedetomidine (0.5mg/kg) plus Normal Saline

Drug: Dexmedetomidine

Dex 1.0

EXPERIMENTAL

Ropivacaine and Lidocaine plus Dexmedetomidine (1.0mg/kg) plus Normal Saline

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dex 0.5; Dex 1.0

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: April 1, 2014
• Primary Completion: January 4, 2019
• Study Completion: January 4, 2019
• Last Updated: March 7, 2019

Record last verified: 2017-11

Locations

CA (1)