Clinical Trial: Liposome Bupivacaine for ANKLE Blocks

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ultrasound-guided Specific Blocks of the Distal Tibial and Deep Peroneal Nerves at the Level of the Ankle With a Mixture of Bupivacaine + Liposome Bupivacaine v Bupivacaine Alone v General Anesthesia

Brief Summary: Postoperative analgesia for hallux valgus surgery (bunionectomy) is inconsistent and may even result in rebound pain when the (ankle) blocks wear off. It is hypothesized that the mixture of bupivacaine and liposome bupivacaine increases the extent and duration of postoperative analgesia and decreases opioid consumption as compared to bupivacaine alone or to general anesthesia.

Detailed Summary:
Sponsor: Admir Hadzic, M.D., Ph.D.

Current Primary Outcome:

  • Change in current pain over the first postoperative week [ Time Frame: From baseline (before nerve block) through first postoperative week ]
    Pain rating (NRS) at rest and with movement
  • Change in worst pain over the first postoperative week [ Time Frame: From discharge from PACU through first postoperative week ]
    Modified BRIEF Pain Inventory (Q1)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in ability to use foot [ Time Frame: From discharge from PACU through first postoperative week ]
    Stand with equal weight on both feet, wiggle toes, walk 10 steps
  • Change in sleep quality [ Time Frame: From discharge from PACU through first postoperative week ]
    Duration (h), quality rating (0 - 10)
  • Change in satisfaction with pain control [ Time Frame: From discharge from PACU through first postoperative week ]
    With pain control (0 - 10)
  • Change in sensory response in skin dermatomes [ Time Frame: From premedication through first postoperative week ]
    Cold, pinprick, light touch in the distal tibial and deep peroneal nerve dermatomes
  • Change in motor response in foot [ Time Frame: From premedication through first postoperative week ]
    Plantar flexion, dorsiflexion


Original Secondary Outcome: Same as current

Information By: New York School of Regional Anesthesia

Dates:
Date Received: March 24, 2017
Date Started: January 2, 2017
Date Completion: August 31, 2017
Last Updated: April 3, 2017
Last Verified: April 2017