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Remote Ischemic PreConditioning Effect on Postsurgical Pain (RIPCEPP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01383317
First Posted: June 28, 2011
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Scott A Miller, Wake Forest University Health Sciences
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning (RIPC) and Its Effect on the Postoperative Pain Experience Following Intra-abdominal Surgery

Further study details as provided by Scott A Miller, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Comparison of pain intensity and unpleasantness postoperatively [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    Pain intensity and unpleasantness will be measured on postoperative day 1 and 2 by using a 0-10 verbal scale after asking the subject to cough.


Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    All opioids administered during postoperative day 1 and 2 will be recorded.

  • Consumption of nonopioid analgesics [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    All non-opioids analgesics administered during postoperative day 1 and 2 will be recorded.


Enrollment: 54
Study Start Date: June 2011
Study Completion Date: April 30, 2017
Primary Completion Date: April 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
Disposable sterile thigh tourniquet
Other Name: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
Sham Comparator: 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
Device: Sham RIPC
Disposable sterile thigh tourniquet
Other Name: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383317


Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: scott A Miller, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Scott A Miller, Assistant Professor of Anesthesiology, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01383317     History of Changes
Other Study ID Numbers: 00016978
First Submitted: June 2, 2011
First Posted: June 28, 2011
Last Update Posted: June 5, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Scott A Miller, Wake Forest University Health Sciences:
Remote Ischemic Preconditioning
Acute Pain