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

NCT01616173 | Completed Phase 4 Results

• 1 other identifier: STU00058849
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture of Ankle

Keywords

Nerve Block; Anesthesia Recovery Period

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (2)

• Opioid Consumption

  2 weeks

• Pain Scores

  2 weeks

Study Arms (3)

Perineural Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Intravenous Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

No Perioperative Steroids

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Dexamethasone DRUG

IV dexamethsone 8mg in 50mL (diluted in NS)

Also known as: DECADRON

Intravenous Dexamethasone

Saline DRUG

2mL

Also known as: Sodium chloride

No Perioperative Steroids

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Dexamethasone; Calcium Dobesilate; Sodium Chloride

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

We enrolled a very specific surgical patient population and all surgical procedures required a saphenous nerve block and the pain in the saphenous nerve distribution could have affected some of our results.

Results Point of Contact

• Title: Rohit Rahangdale MD
• Organization: Northwestern University, Feinberg School of Medicine

ryrahangdale@hotmail.com

312-695-3045

Study Officials

• Rohit Rahangdale, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 11, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 20, 2014
• Results First Posted: November 20, 2014

Record last verified: 2014-11

Locations

US (1)