Hospital For Special Surgery
New York, 10021, United States
NCT Number: NCT02198235
This study looks at addition of medications to the local anesthetic for the nerve blockade.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
New York, 10021, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 hours after the popliteal block is given
Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)
Time frame: 24 hours and 48 hours after the popliteal block is given
When did the nerve block entirely wear off?
Time frame: 24 hours after the popliteal block is given
Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)
Time frame: 24 hours after the popliteal block is given
Did patient have pain requiring oral opioids?
Hospital for Special Surgery, New York
Other
Prolonged Popliteal Fossa Nerve Blockade
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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