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Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block

Primary Purpose

Fracture of Ankle

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Dexamethasone
Saline
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fracture of Ankle focused on measuring Nerve Block, Anesthesia Recovery Period

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia.
  • Surgery confined to the foot and ankle.
  • Patients aged 18-70 years.

Exclusion Criteria:

  • ASA Classification of 4 or higher.
  • Pre-existing neuropathy
  • Coagulopathy
  • Infection at the site
  • Diabetes
  • Non-English speaking or reading patients
  • Systemic use of corticosteroids within 6 months of surgery
  • Chronic opioid use
  • Pregnancy
  • Large (>3cm) skin incision around the medial aspect of the foot
  • Any other contra-indication to regional anesthesia

Sites / Locations

  • Northwestern University, Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Perineural Dexamethasone

Intravenous Dexamethasone

No Perioperative Steroids

Arm Description

Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL, and 50mL IV normal saline infusion

Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion

Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion

Outcomes

Primary Outcome Measures

Quality of Recovery
QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.

Secondary Outcome Measures

Opioid Consumption
Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.
Pain Scores
Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).

Full Information

First Posted
June 6, 2012
Last Updated
November 12, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01616173
Brief Title
Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block
Official Title
The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The investigators are investigating the use of perineural dexamethasone together with local anesthetics can improve the quality of recovery for patients receiving sciatic nerve blocks for foot and ankle surgery.
Detailed Description
Patients scheduled to have foot and ankle surgery will typically receive a single shot sciatic nerve block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. Perineural dexamethasone has been investigated as an adjuvant for brachial plexus nerve blocks but its effect on sciatic nerve block outcomes has yet to be determined. More importantly, it is not known whether the beneficial effect of perineural dexamethasone on analgesia duration leads to a better quality of surgical recovery. We hypothesized that perineural dexamethasone leads to a better quality of postsurgical recovery than intravenous dexamethasone or saline control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Ankle
Keywords
Nerve Block, Anesthesia Recovery Period

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perineural Dexamethasone
Arm Type
Active Comparator
Arm Description
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL, and 50mL IV normal saline infusion
Arm Title
Intravenous Dexamethasone
Arm Type
Active Comparator
Arm Description
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion
Arm Title
No Perioperative Steroids
Arm Type
Placebo Comparator
Arm Description
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
DECADRON
Intervention Description
IV dexamethsone 8mg in 50mL (diluted in NS)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
DECADRON
Intervention Description
8mg/2mL
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Sodium chloride
Intervention Description
2mL
Primary Outcome Measure Information:
Title
Quality of Recovery
Description
QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.
Time Frame
2 weeks
Title
Pain Scores
Description
Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1-3 patients who are presenting for foot and ankle surgery and are candidates for a single injection sciatic nerve block to provide postoperative analgesia. Surgery confined to the foot and ankle. Patients aged 18-70 years. Exclusion Criteria: ASA Classification of 4 or higher. Pre-existing neuropathy Coagulopathy Infection at the site Diabetes Non-English speaking or reading patients Systemic use of corticosteroids within 6 months of surgery Chronic opioid use Pregnancy Large (>3cm) skin incision around the medial aspect of the foot Any other contra-indication to regional anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohit Rahangdale, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University, Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block

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