Clinical trial NCT01383317: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Remote Ischemic Preconditioning
Acute Pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 64
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Comparison of Pain Intensity and Unpleasantness Postoperatively
timeFrame: Postoperative day 1 and postoperative day 2
Secondary outcomes:
measure: Number of Participants That Consumed Opioids
timeFrame: Postoperative day 1 and postoperative day 2
measure: Consumption of Nonopioid Analgesics
timeFrame: Postoperative day 1 and postoperative day 2
measure: Use of Antiemetics
timeFrame: Postoperative day 1 and postoperative day 2
measure: Level of Sedation
timeFrame: Postoperative day 1 and postoperative day 2
measure: McGill Pain Sensory
timeFrame: Postoperative day 1 and postoperative day 2
measure: Leg Pain at 48 Hours
timeFrame: postoperative day 2
measure: Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo
timeFrame: Postoperative day 1 and postoperative day 2
measure: Pain Unpleasantness
timeFrame: Postoperative day 1 and postoperative day 2
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Scott A Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: