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
  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: Double Blind (Subject, Caregiver, 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 Wake Forest Baptist Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383317

Contacts
Contact: Scott A Miller, MD 336-713-5361 scmiller@wfubmc.edu
Contact: Peg Jordan, BSN 336-716-4498 scootermiller00@hotmail.com

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Scott A Miller, MD    336-716-4498    scmiller@wfubmc.edu   
Principal Investigator: Scott A Miller, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
Investigators
Principal Investigator: scott A Miller, MD Wake Forest Baptist Health
  More Information

No publications provided

Responsible Party: Scott A Miller, Assistant Professor of Anesthesiology, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01383317     History of Changes
Other Study ID Numbers: 00016978
Study First Received: June 2, 2011
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014