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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01641419

Enrollment

Registered

2012-07-16

Start date

2012-07-31

Completion date

2014-12-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Sciatic Block

Keywords

Pain, Ropivacaine, sciatic block, dexamethasone

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.

Interventions

DRUGPlacebo

2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block

DRUGDexamethasone 4 mg

2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

DRUGDexamethasone 8 mg

2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026