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Completed

NCT Number: NCT01975285

Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery

The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.

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Key information

Conditions

Foot and Ankle Procedures Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 patients (30 per group) undergoing foot and ankle procedures
  • Willingness and ability to sign an informed consent document
  • No allergies to anesthetic or analgesic medications
  • American Society of Anesthesiologists (ASA)physical status Class I - III
  • Aged 18-90 years,either sex

Exclusion criteria

  • Refusal to participate in the study
  • Age<18 or> 90 years -
  • Contraindications to regional blockage including but not limited to:
  • Patient refusal to regional blockade
  • Infection at the site of needle insertion
  • Systemic infection
  • Bleeding diathesis or coagulopathy

Treatment and study plan

Dexamethasone

Drug

0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc

Other names: Decadron

Saline

Drug

0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc

Other names: placebo

Primary outcomes

  1. Postoperative Pain

    Time frame: 3 days

    Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain

Secondary outcomes

  1. Opioid Consumption

    Time frame: 3 days

    Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)

  2. Length of Analgesia

    Time frame: 3 days

    Time in days and/or hours

  3. Patient Satisfaction With Regional Nerve Block

    Time frame: 3 days

    Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied

  4. Patient Satisfaction With Pain Management

    Time frame: 3 days

    Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Prospective Randomized Double Blind Study to Evaluate the Efficacy of Popliteal Nerve Blocks With and Without Dexamethasone on the Duration of Analgesia for Foot & Ankle Surgery.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 4, 2013
Registry last updated
May 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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