Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)
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|ClinicalTrials.gov Identifier: NCT02198235|
Recruitment Status : Completed
First Posted : July 23, 2014
Results First Posted : February 29, 2016
Last Update Posted : June 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Dexamethasone Drug: Buprenorphine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prolonged Popliteal Fossa Nerve Blockade|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||February 2014|
Active Comparator: Control NB + IV Dex + IV Bup
IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
Active Comparator: Control NB + IV Dex
IV Dexamethasone (4 mg)
Experimental: NB with Dex + Bup in block.
Dexamethasone (4 mg) Buprenorphine (150 mcg)
- Numeric Rating Scale (NRS) Pain Score With Movement [ 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)
- Block Duration [ Time Frame: 24 hours and 48 hours after the popliteal block is given ]When did the nerve block entirely wear off?
- Numeric Rating Scale (NRS) Pain Score at Rest [ 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)
- Median Time to Requiring Oral Opioids [ Time Frame: 24 hours after the popliteal block is given ]Did patient have pain requiring oral opioids?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198235
|United States, New York|
|Hospital For Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Jacques YaDeau, MD, PhD||Hospital for Special Surgery, New York|