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Remote Ischemic PreConditioning Effect on Postsurgical Pain (RIPCEPP)

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ClinicalTrials.gov Identifier: NCT01383317
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : January 12, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1) Device: Sham RIPC Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : April 30, 2017

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 (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.


Secondary Outcome Measures :
  1. Number of Participants That Consumed Opioids [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.

  2. 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 and the number of participants that used nonopiods will be given.

  3. Use of Antiemetics [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.

  4. Level of Sedation [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    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.

  5. McGill Pain Sensory [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    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.

  6. Leg Pain at 48 Hours [ Time Frame: postoperative day 2 ]
    Number of participants that had leg pain at 48 hours.

  7. Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    Participants were questioned to see if they knew what interventional group they belonged to.

  8. Pain Unpleasantness [ Time Frame: Postoperative day 1 and postoperative day 2 ]
    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.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
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

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

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01383317     History of Changes
Other Study ID Numbers: 00016978
First Posted: June 28, 2011    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: September 5, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Wake Forest University Health Sciences:
Remote Ischemic Preconditioning
Acute Pain