Remote Ischemic Preconditioning Mechanism Study
Remote Ischemic Preconditioning Effects on Central and Peripheral Sensitization in Healthy Volunteers-A Pilot Study
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157
- WakeForestUBMC
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- pregnancy
- allergy to capsaicin
- lower extremity vascular insufficiency
- active treatment for DVT
- severe thigh pain
- taking psychotropic medications, including anti-depressants.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Capsaicin, UV-B, RIPC
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The participants will have one disposable tourniquet applied to the left mid thigh by research personnel.
The participants will then be randomized to the treatment group or sham group.
The treatment group will receive 3 cycles of RIPC to the left lower leg by occluding blood flow at the thigh with a pneumatic cuff.
Each cycle will consist of 5 minutes of ischemia by inflating the cuff to 300 mmHg followed by 5 minutes of reperfusion.
The sham group will have the cuff inflated to no more than 15mmHg for three cycles as described above.
Areas of hypersensitivity and allodynia will be obtained every 40 min for 280 min following the end of capsaicin application.
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Sham-komparator: Capsaicin, UV-B
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The participants will have one disposable tourniquet applied to the left mid thigh by research personnel.
The participants will then be randomized to the treatment group or sham group.
The treatment group will receive 3 cycles of RIPC to the left lower leg by occluding blood flow at the thigh with a pneumatic cuff.
Each cycle will consist of 5 minutes of ischemia by inflating the cuff to 300 mmHg followed by 5 minutes of reperfusion.
The sham group will have the cuff inflated to no more than 15mmHg for three cycles as described above.
Areas of hypersensitivity and allodynia will be obtained every 40 min for 280 min following the end of capsaicin application.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Areas of hyperalgesia and allodynia to mechanical stimuli.
Tidsramme: 24 hours
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Hyperalgesia will be measured with vonFrey fibers and allodynia will be measured with a cotton wisp.
The area will be measured in cm2.
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24 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity and unpleasantness to mechanical stimuli
Tidsramme: 24 hours
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Using a Visual Analog Sliding Scale the intensity and unpleasantness will be measured in centimeters.
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24 hours
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Presence of parathesias where RIPC was used
Tidsramme: 24 hours
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After a brief tourniquet application I fully expect participants to have some degree of parasthesias.
Using a standard rating scale I will record and report this.
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24 hours
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Scott A Miller, MD, Wake Forest University Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00019284
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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