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

Pain, Sciatic Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01641419
• Other study ID #: H-30398
• Status: Withdrawn
• Phase: N/A
• First received: July 11, 2012
• Last updated: March 13, 2015
• Start date: July 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Sciatic Block

Intervention

Drug:
• Placebo
2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block
• Dexamethasone 4 mg
2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
• Dexamethasone 8 mg
2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No