Remote Ischemic Preconditioning Mechanism Study

NCT ID: NCT01541436

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-04-30

Brief Summary

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.

Detailed Description

The purpose of this pilot study is to determine whether RIPC effects peripheral sensitization, central sensitization or both and determine effect size since there is no data regarding the presumed effect. These issues cannot be easily sorted out in patients experiencing postoperative pain and hypersensitivity, since surgery affects both components. In order to address this purpose the investigators will examine, in healthy volunteers, the effect of RIPC on a manipulation which generates hypersensitivity by an exclusive peripheral mechanism (ultraviolet B (UV-B) burn) and a manipulation which generates hypersensitivity by an exclusive central mechanism (topical capsaicin). Understanding the sites at which RIPC reduces the amplification of pain after injury will be useful in determining where it would be most logically applied clinically and in guiding preclinical mechanistic studies.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Capsaicin, UV-B, RIPC

Group Type: ACTIVE_COMPARATOR

Remote Ischemic Preconditioning, Capsaicin, UV-B

Intervention Type: DEVICE

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.

Capsaicin, UV-B

Group Type: SHAM_COMPARATOR

Remote Ischemic Preconditioning, Capsaicin, UV-B

Intervention Type: DEVICE

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.

Interventions

Remote Ischemic Preconditioning, Capsaicin, UV-B

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott A Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

WakeForestUBMC

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

00019284

Identifier Type: -

Identifier Source: org_study_id