Remote Ischemic Preconditioning Mechanism Study
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Pain
In brief
This research is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications. Although Remote Ischemic Preconditioning (RIPC) appears promising, there remain several unanswered questions about how it works. This research trial will help determine how RIPC may activate the bodies natural pain control system. The goals of this study are to see if RIPC has any effect 1) on a small area of skin that will be expose to a small amount of UV- B radiation (a mild sunburn), 2) on acute thermal heat temperatures that will be applied to skin, and 3) on the sunburn-like sensation to light touch after putting capsaicin cream (the active ingredient in hot chili peppers) on skin. Remote ischemic preconditioning is done by inflating a balloon (very similar to a blood pressure cuff) on the leg until it blocks blood flow for a few minutes. The cuff is then deflated and blood flow resumes. The process is repeated up to three times. This procedure causes the body to increase its natural pain relief system that may help to decrease the amount of postsurgical pain.
Key facts
- Study ID
- NCT01541436
- Run by
- Wake Forest University Health Sciences
- People needed
- 20
- Starts
- 2012-03-01
- Expected to finish
- 2017-04-30
- Last updated by the study team
- 2018-08-10
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- healthy volunteers of both sexes ASA 1 or II classification
- between the ages of 18-55
- weighing less than 250 pounds
- without chronic pain
- not taking analgesics
- off caffeine for 2 days.
You may not qualify if…
- pregnancy
- allergy to capsaicin
- lower extremity vascular insufficiency
- active treatment for DVT
- severe thigh pain
- taking psychotropic medications, including anti-depressants.
Where it is running
- WakeForestUBMC — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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