This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Remote Ischemic PreConditioning Effect on Postsurgical Pain (RIPCEPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scott A Miller, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01383317
First received: June 2, 2011
Last updated: June 2, 2017
Last verified: June 2017
June 2, 2011
June 2, 2017
June 2011
April 30, 2016   (Final data collection date for primary outcome measure)
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.
Comparison of pain intensity and unpleasantness postoperatively [ Time Frame: Postoperative day 1 and postoperative day 2 ]
Pain intensity and upleasantness will be measured on postoperative day 1 and 2 by using a 0-10 verbal scale after asking the subject to cough.
Complete list of historical versions of study NCT01383317 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Remote Ischemic PreConditioning Effect on Postsurgical Pain
Remote Ischemic Preconditioning (RIPC) and Its Effect on the Postoperative Pain Experience Following Intra-abdominal Surgery
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Pain
  • 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
  • Device: Sham RIPC
    Disposable sterile thigh tourniquet
    Other Name: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
  • 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
    Intervention: Device: Thigh Tourniquet (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
    Intervention: Device: Sham RIPC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
April 30, 2017
April 30, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01383317
00016978
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Not Provided
Not Provided
Scott A Miller, Wake Forest University Health Sciences
Wake Forest University Health Sciences
Not Provided
Principal Investigator: scott A Miller, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP