Analgesic Benefits of Perineural Versus Intravenous Dexamethasone in Patients Receiving Sciatic Nerve Block
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes|
- Quality of Recovery [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]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.
- Opioid Consumption [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.
- Pain Scores [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).
|Study Start Date:||June 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Perineural Dexamethasone
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
Other Name: DECADRON
Active Comparator: Intravenous Dexamethasone
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and IV dexamethsone 8mg in 50mL infusion
IV dexamethsone 8mg in 50mL (diluted in NS)
Other Name: DECADRON
Placebo Comparator: No Perioperative Steroids
Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline and 50mL infusion
Other Name: Sodium chloride
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616173
|United States, Illinois|
|Northwestern University, Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Rohit Rahangdale, MD||Northwestern University, Feinberg School of Medicine|