Expired Study
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Winston-Salem, North Carolina 27157


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.


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


Study is Available At:


Original ID:

00016978


NCT ID:

NCT01383317


Secondary ID:


Study Acronym:

RIPCEPP


Brief Title:

Remote Ischemic PreConditioning Effect on Postsurgical Pain


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

30 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University Health Sciences


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

64


Enrollment Type:

Actual


Overall Contact Information

Official Name:Scott A Miller, MD
Principal Investigator
Wake Forest University Health Sciences

Study Dates

Start Date:June 2011
Completion Date:April 30, 2017
Completion Type:Actual
Primary Completion Date:April 30, 2016
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 7, 2018
First Received Date:June 2, 2011
First Results Date:December 15, 2017

Study Outcomes

Outcome Type:Primary Outcome
Measure:Comparison of Pain Intensity and Unpleasantness Postoperatively
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Number of Participants That Consumed Opioids
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description:All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.
Outcome Type:Secondary Outcome
Measure:Consumption of Nonopioid Analgesics
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Use of Antiemetics
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description:Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.
Outcome Type:Secondary Outcome
Measure:Level of Sedation
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description: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 unrespo
Outcome Type:Secondary Outcome
Measure:McGill Pain Sensory
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Leg Pain at 48 Hours
Time Frame:postoperative day 2
Safety Issues:False
Description:Number of participants that had leg pain at 48 hours.
Outcome Type:Secondary Outcome
Measure:Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description:Participants were questioned to see if they knew what interventional group they belonged to.
Outcome Type:Secondary Outcome
Measure:Pain Unpleasantness
Time Frame:Postoperative day 1 and postoperative day 2
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Device
Name:Sham RIPC
Description:Disposable sterile thigh tourniquet
Arm Name:Sham RIPC
Other Name:VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-
Intervention Type:Device
Name:Thigh Tourniquet (VBM Single Use Tourniquet Cuff I
Description:Disposable sterile thigh tourniquet
Arm Name:RIPC
Other Name:VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-

Study Arms

Study Arm Type:Active Comparator
Arm Name:RIPC
Description: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
Study Arm Type:Sham Comparator
Arm Name:Sham RIPC
Description: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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University Health Sciences

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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