Remote Ischemic PreConditioning Effect on Postsurgical Pain

Study Overview
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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.

Official Title
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Remote Ischemic Preconditioning (RIPC) and Its Effect on the Postoperative Pain Experience Following Intra-abdominal Surgery

Conditions
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Pain

Intervention / Treatment
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* Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
* Device: Sham RIPC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 30-80 Undergoing elective open intra-peritoneal surgery Able to provide written informed consent to participate Laparoscopic abdominal surgery Exclusion Criteria: Ongoing Workman's Compensation claim >50mg/day of oral morphine or morphine equivalent Currently being treated for lower extremity DVT Known intracranial hypertension (not excluding patients with a functioning VP shunt) Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency) Ongoing localized thigh pain Planned epidural analgesia Pregnancy Any DSM IV-R Axis I psychotic disorders Unable to understand English Unable to understand the consent form

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIPC<br>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 | Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)<br>* Disposable sterile thigh tourniquet<br>* Other names: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1;|
| Sham Comparator: Sham RIPC<br>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 | Device: Sham RIPC<br>* Disposable sterile thigh tourniquet<br>* Other names: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Pain Intensity and Unpleasantness Postoperatively | Pain intensity and unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain. | Postoperative day 1 and postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Consumed Opioids | All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given. | Postoperative day 1 and postoperative day 2 | 
| Consumption of Nonopioid Analgesics | All non-opioids analgesics administered during postoperative day 1 and 2 will be recorded and the number of participants that used nonopiods will be given. | Postoperative day 1 and postoperative day 2 | 
| Use of Antiemetics | Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded. | Postoperative day 1 and postoperative day 2 | 
| Level of Sedation | The Ramsey Sedation Scale (RSS) was used to determine the level of sedation. Th RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive. The score range is from 1-6, with higher scores denoting worse outcomes. | Postoperative day 1 and postoperative day 2 | 
| McGill Pain Sensory | The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience. The scale range is 0-78, with higher scores denoting worse outcomes. | Postoperative day 1 and postoperative day 2 | 
| Leg Pain at 48 Hours | Number of participants that had leg pain at 48 hours. | postoperative day 2 | 
| Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | Participants were questioned to see if they knew what interventional group they belonged to. | Postoperative day 1 and postoperative day 2 | 
| Pain Unpleasantness | Pain unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain. | Postoperative day 1 and postoperative day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Ischemic Preconditioning, Acute Pain