Remote Ischemic PreConditioning Effect on Postsurgical Pain (RIPCEPP)

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1); Device: Sham RIPC

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Pain Intensity and Unpleasantness Postoperatively	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.	Postoperative day 1 and postoperative day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants That Consumed Opioids	All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.	Postoperative day 1 and postoperative day 2
Consumption of Nonopioid Analgesics	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.	Postoperative day 1 and postoperative day 2
Use of Antiemetics	Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.	Postoperative day 1 and postoperative day 2
Level of Sedation	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.	Postoperative day 1 and postoperative day 2
McGill Pain Sensory	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.	Postoperative day 1 and postoperative day 2
Leg Pain at 48 Hours	Number of participants that had leg pain at 48 hours.	postoperative day 2
Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo	Participants were questioned to see if they knew what interventional group they belonged to.	Postoperative day 1 and postoperative day 2
Pain Unpleasantness	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.	Postoperative day 1 and postoperative day 2

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Scott A Miller, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Acute Pain; Remote Ischemic Preconditioning
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 00016978

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes