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Upper Limb Amputation Below Elbow clinical trials at UCSD
1 in progress, 0 open to new patients

  • Cryoanalgesia to Prevent Acute and Chronic Pain Following Mastectomy and Limb Amputation: A Randomized, Double-Masked, Sham-Controlled Study

    Sorry, accepting new patients by invitation only

    The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following mastectomy or limb amputation; and, if this analgesic modality decreases the risk of persistent postoperative pain, or "chronic" pain. The objective of the proposed pilot study is to optimize the protocol and collect data to power a subsequent, definitive clinical trial. Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-mastectomy pain. Hypothesis 1a (primary): The severity of breast pain will be significantly decreased following mastectomy on postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving standard-of-care treatment. Hypothesis 1b: The incidence of chronic pain will be significantly decreased one year following mastectomy with the addition of cryoanalgesia as compared with patients receiving standard-of-care treatment. Hypothesis 1c: The severity of chronic pain will be significantly decreased one year following mastectomy with the addition of cryoanalgesia as compared with patients receiving standard-of-care treatment. Specific Aim 2: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-amputation pain. Hypothesis 2a: The severity of operative limb pain will be significantly decreased in the week following a surgical limb amputation with the addition of cryoanalgesia as compared with patients receiving standard-of-care treatment. Hypothesis 2b: The incidence of chronic pain will be significantly decreased in the year following a surgical limb amputation with the addition of cryoanalgesia as compared with patients receiving standard-of-care treatment. Hypothesis 2c: The severity of chronic pain will be significantly decreased in the year following a surgical limb amputation with the addition of cryoanalgesia as compared with patients receiving standard-of-care treatment.

    San Diego, California