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Completed

NCT Number: NCT01383317

Remote Ischemic PreConditioning Effect on Postsurgical Pain

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.

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Key information

Conditions

Pain Acute Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 30-80
  • Undergoing elective open intra-peritoneal surgery
  • Able to provide written informed consent to participate
  • Laparoscopic abdominal surgery

Exclusion criteria

  • Ongoing Workman's Compensation claim
  • >50mg/day of oral morphine or morphine equivalent
  • Currently being treated for lower extremity DVT
  • Known intracranial hypertension (not excluding patients with a functioning VP shunt)
  • Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency)
  • Ongoing localized thigh pain
  • Planned epidural analgesia
  • Pregnancy
  • Any DSM IV-R Axis I psychotic disorders
  • Unable to understand English
  • Unable to understand the consent form

Treatment and study plan

Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)

Device

Disposable sterile thigh tourniquet

Other names: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1

Sham RIPC

Device

Disposable sterile thigh tourniquet

Other names: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: RIPCEPP

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jun 28, 2011
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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