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Completed

NCT Number: NCT02198235

Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital For Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery
  • Patients aged 18-75
  • Patients scheduled for discharge from HSS after foot or ankle surgery
  • A single-injection popliteal fossa nerve block is judged appropriate
  • Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion)

Exclusion criteria

  • < 18 and > 75
  • Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft)
  • Bilateral surgery
  • Chronic pain (defined as regular use of opioid analgesics for > 3 months)
  • Chronic use of steroids (defined as regular use of steroids for > 3 months)
  • Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine (e.g. alleged bupivacaine sensitivity, low body weight, etc.)
  • Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.)
  • Patients who have been diagnosed with altered pain perception or have lack of sensation
  • Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia)
  • Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)

Treatment and study plan

Dexamethasone

Drug

buprenorphine

Drug

Primary outcomes

  1. 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)

Secondary outcomes

  1. Block Duration

    Time frame: 24 hours and 48 hours after the popliteal block is given

    When did the nerve block entirely wear off?

  2. 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)

  3. Median Time to Requiring Oral Opioids

    Time frame: 24 hours after the popliteal block is given

    Did patient have pain requiring oral opioids?

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Prolonged Popliteal Fossa Nerve Blockade

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2014
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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