NCT02198235

Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

Prolonged Popliteal Fossa Nerve Blockade

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study looks at addition of medications to the local anesthetic for the nerve blockade.

Detailed description

Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain. Patients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Dexamethasone
DRUG	Buprenorphine

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2014-07-23
• Last updated: 2017-06-15
• Results posted: 2016-02-29

Locations

1 site across 1 country: United States