Remote Ischemic PreConditioning Effect on Postsurgical Pain (RIPCEPP)
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
Sham RIPC
Sponsored by

About this trial
This is an interventional treatment trial for Pain focused on measuring Remote Ischemic Preconditioning, Acute Pain
Eligibility Criteria
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
Sites / Locations
- Wake Forest University Baptist Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
RIPC
Sham RIPC
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Use of Antiemetics
Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.
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.
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.
Leg Pain at 48 Hours
Number of participants that had leg pain at 48 hours.
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.
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.
Full Information
NCT ID
NCT01383317
First Posted
June 2, 2011
Last Updated
August 7, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01383317
Brief Title
Remote Ischemic PreConditioning Effect on Postsurgical Pain
Acronym
RIPCEPP
Official Title
Remote Ischemic Preconditioning (RIPC) and Its Effect on the Postoperative Pain Experience Following Intra-abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
April 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Remote Ischemic Preconditioning, Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RIPC
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham RIPC
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
Other Intervention Name(s)
VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
Intervention Description
Disposable sterile thigh tourniquet
Intervention Type
Device
Intervention Name(s)
Sham RIPC
Other Intervention Name(s)
VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
Intervention Description
Disposable sterile thigh tourniquet
Primary Outcome Measure Information:
Title
Comparison of Pain Intensity and Unpleasantness Postoperatively
Description
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.
Time Frame
Postoperative day 1 and postoperative day 2
Secondary Outcome Measure Information:
Title
Number of Participants That Consumed Opioids
Description
All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.
Time Frame
Postoperative day 1 and postoperative day 2
Title
Consumption of Nonopioid Analgesics
Description
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.
Time Frame
Postoperative day 1 and postoperative day 2
Title
Use of Antiemetics
Description
Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.
Time Frame
Postoperative day 1 and postoperative day 2
Title
Level of Sedation
Description
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.
Time Frame
Postoperative day 1 and postoperative day 2
Title
McGill Pain Sensory
Description
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.
Time Frame
Postoperative day 1 and postoperative day 2
Title
Leg Pain at 48 Hours
Description
Number of participants that had leg pain at 48 hours.
Time Frame
postoperative day 2
Title
Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo
Description
Participants were questioned to see if they knew what interventional group they belonged to.
Time Frame
Postoperative day 1 and postoperative day 2
Title
Pain Unpleasantness
Description
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.
Time Frame
Postoperative day 1 and postoperative day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott A Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Remote Ischemic PreConditioning Effect on Postsurgical Pain
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