PainRIPCEPPNCT01383317
Remote Ischemic PreConditioning Effect on Postsurgical Pain
A study testing Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1) in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 30-80
- Undergoing elective open intra-peritoneal surgery
- Able to provide written informed consent to participate
- Laparoscopic abdominal surgery
Who cannot join
- 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
Show all 11Show fewer
- Planned epidural analgesia
- Pregnancy
- Any DSM IV-R Axis I psychotic disorders
- Unable to understand English
- Unable to understand the consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
- Conditions
- Pain
- Being tested
- Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1), Sham RIPC
- Keywords
- Remote Ischemic Preconditioning, Acute Pain
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)Device
Also called VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
Disposable sterile thigh tourniquet
Sham RIPCDevice
Also called VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
Disposable sterile thigh tourniquet
| Study group | Role | What they receive |
|---|---|---|
| RIPC | Active comparator | 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 Receives: Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1) |
| Sham RIPC | Sham comparator | 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 Receives: Device: Sham RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1 and postoperative day 2
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative day 1 and postoperative day 2
Leg Pain at 48 Hours
Number of participants that had leg pain at 48 hours.
Measured: 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.
Measured: 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.
Measured: Postoperative day 1 and postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completion30 Apr 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott A Miller, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383317
- Sponsor's protocol ID
- 00016978
- Acronym
- RIPCEPP
- Status last verified
- Aug 2018
- First submitted
- 2 Jun 2011
- Last updated
- 5 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning (RIPC) and Its Effect on the Postoperative Pain Experience Following Intra-abdominal Surgery
- ClinicalTrials.gov ID
- NCT01383317
- Acronym / sponsor ID
- RIPCEPP / 00016978
- Conditions
- Pain
- Keywords
- Remote Ischemic Preconditioning, Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Posted 12 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC | Active comparator | Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)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 |
| Sham RIPC | Sham comparator | Device: Sham RIPCA tourniquet on the thigh will be inflated to 15 mmHg for 5 minutes then deflated for 5 minutes. This will be repeated three times |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 30-80
- Undergoing elective open intra-peritoneal surgery
- Able to provide written informed consent to participate
- Laparoscopic abdominal surgery
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)Also: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1Disposable sterile thigh tourniquet | Device | RIPC |
| Sham RIPCAlso: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1Disposable sterile thigh tourniquet | Device | Sham RIPC |
Primary outcome
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.
8 secondary outcomes
Number of Participants That Consumed Opioids
Time frame: Postoperative day 1 and postoperative day 2
Consumption of Nonopioid Analgesics
Time frame: Postoperative day 1 and postoperative day 2
Use of Antiemetics
Time frame: Postoperative day 1 and postoperative day 2
Level of Sedation
Time frame: Postoperative day 1 and postoperative day 2
McGill Pain Sensory
Time frame: Postoperative day 1 and postoperative day 2
Leg Pain at 48 Hours
Time frame: postoperative day 2
Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo
Time frame: Postoperative day 1 and postoperative day 2
Pain Unpleasantness
Time frame: Postoperative day 1 and postoperative day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott A Miller, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1) in people with Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Pain Intensity and Unpleasantness Postoperatively (time frame: Postoperative day 1 and postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.