Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg

Not Applicable

Withdrawn

• Conditions: Pain, Sciatic Block
• Interventions: Drug: Placebo; Drug: Dexamethasone 8 mg; Drug: Dexamethasone 4 mg

• Registration Number: NCT01641419
• Lead Sponsor: Baylor College of Medicine

Brief Summary

The purpose is to find out if the addition of dexamethasone to ropivacaine 0.5% increases the duration of pain relief provided by popliteal sciatic nerve block performed for foot/ankle surgery. The investigators also want to find out if there is a difference between 4 and 8 mg dose of dexamethasone.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-16
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Ages 18-64
• ASA Physcial Status classification 1-3
• Foot and ankle surgery at Ben Taub General Hospital

Exclusion Criteria

• diabetes mellitus
• peripheral neuropathy
• coagulopathy
• allergy to study drugs
• systemic glucocorticoid treatment (for 2 weeks or more) within 6 months of surgery
• chronic opioid use at home
• patient inability to properly describe pain to investigators
• pregancy
• prisoners
• patient or surgeon refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Ropivacaine 0.5% plus 2ml of normal saline used for nerve block
Dexamethasone 8 mg	Dexamethasone 8 mg	Ropivacaine 0.5% plus 2ml of dexamethasone 8 mg used for nerve block
Dexamethasone 4 mg	Dexamethasone 4 mg	Ropivacaine 0.5% plus 2ml of dexamethasone 4 mg used for nerve block

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	48 hours	Duration of analgesia of popliteal fossa sciatic nerve block defined as time of first pain as described by patient minus time of block placement in minutes

Secondary Outcome Measures

Name	Time	Method
Total pain medication	24 hours	Total amounts of morphine, fentanyl and hydrocodone/acetaminophen that the patient required for pain control during first 24 hours after surgery.; All patients, regardless of group, will receive a standardized postoperative pain medication regimen which will include hydrocodone/acetaminophen tablets primarily, and morphine/fentanyl as needed.
Pain scores	24 hours	Pain score measured of numeric analog scale from 0-10 during first 24 hours measures and 0,1,2,4,8,12, and 24 hours after surgery.

Trial Locations

Locations (1)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States