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

Randomized, Controlled 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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Sciatic Block
• Intervention / Treatment: Drug: Placebo; Drug: Dexamethasone 4 mg; Drug: Dexamethasone 8 mg

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Ropivacaine 0.5% plus 2ml of normal saline used for nerve block	Drug: Placebo; 2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block
ACTIVE_COMPARATOR: Dexamethasone 4 mg; Ropivacaine 0.5% plus 2ml of dexamethasone 4 mg used for nerve block	Drug: Dexamethasone 4 mg; 2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
ACTIVE_COMPARATOR: Dexamethasone 8 mg; Ropivacaine 0.5% plus 2ml of dexamethasone 8 mg used for nerve block	Drug: Dexamethasone 8 mg; 2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	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	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total pain medication	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.	24 hours
Pain scores	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.	24 hours

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 13, 2012
• First Posted (ESTIMATE): July 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Pain; sciatic block; dexamethasone; Ropivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: H-30398