Remote Ischemic PreConditioning Effect on Postsurgical Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2017-04-30

Brief Summary

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Remote Ischemic PreConditioning (RIPC) will improve the postoperative pain experience in patients undergoing abdominal surgery. Although abdominal surgery can be a lifesaving procedure many people have a significant amount of postsurgical pain. Severe postsurgical pain may lead to chronic pain in some people. "Remote Ischemic Preconditioning" may reduce the amount of postsurgical pain. 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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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RIPC

A tourniquet on the thigh will be inflated to 300 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times

Group Type ACTIVE_COMPARATOR

Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)

Intervention Type DEVICE

Disposable sterile thigh tourniquet

Sham RIPC

A tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times

Group Type SHAM_COMPARATOR

Sham RIPC

Intervention Type DEVICE

Disposable sterile thigh tourniquet

Interventions

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Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)

Disposable sterile thigh tourniquet

Intervention Type DEVICE

Sham RIPC

Disposable sterile thigh tourniquet

Intervention Type DEVICE

Other Intervention Names

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VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1 VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1

Eligibility Criteria

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Inclusion Criteria

1. Ages 30-80
2. Undergoing elective open intra-peritoneal surgery
3. Able to provide written informed consent to participate
4. Laparoscopic abdominal surgery

Exclusion Criteria

1. Ongoing Workman's Compensation claim
2. \>50mg/day of oral morphine or morphine equivalent
3. Currently being treated for lower extremity DVT
4. Known intracranial hypertension (not excluding patients with a functioning VP shunt)
5. Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency)
6. Ongoing localized thigh pain
7. Planned epidural analgesia
8. Pregnancy
9. Any DSM IV-R Axis I psychotic disorders
10. Unable to understand English
11. Unable to understand the consent form

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No