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Remote Ischemic PreConditioning Effect on Postsurgical Pain (RIPCEPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Wake Forest Baptist Health
Sponsor:
Information provided by (Responsible Party):
Scott A Miller, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01383317
First received: June 2, 2011
Last updated: May 28, 2013
Last verified: May 2013

June 2, 2011
May 28, 2013
June 2011
December 2013   (final data collection date for primary outcome measure)
Comparison of pain intensity and unpleasantness postoperatively [ Time Frame: Postoperative day 1 and postoperative day 2 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01383317 on ClinicalTrials.gov Archive Site
  • Opioid consumption [ Time Frame: Postoperative day 1 and postoperative day 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: Double Blind (Subject, Caregiver, 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.
 
Recruiting
80
March 2014
December 2013   (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
Both
30 Years to 80 Years
No
Contact: Scott A Miller, MD 336-713-5361 scmiller@wfubmc.edu
Contact: Peg Jordan, BSN 336-716-4498 scootermiller00@hotmail.com
United States
 
NCT01383317
00016978
No
Scott A Miller, Wake Forest University Baptist Medical Center
Wake Forest Baptist Health
Not Provided
Principal Investigator: scott A Miller, MD Wake Forest Baptist Health
Wake Forest Baptist Health
May 2013

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