NCT01383317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 12, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

4.9 years

First QC Date

June 2, 2011

Results QC Date

December 15, 2017

Last Update Submit

August 7, 2018

Conditions

Pain

Keywords

Remote Ischemic PreconditioningAcute Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Number of Participants That Consumed Opioids

    Postoperative day 1 and postoperative day 2

  • Consumption of Nonopioid Analgesics

    Postoperative day 1 and postoperative day 2

  • Use of Antiemetics

    Postoperative day 1 and postoperative day 2

  • Level of Sedation

    Postoperative day 1 and postoperative day 2

  • McGill Pain Sensory

    Postoperative day 1 and postoperative day 2

  • +3 more secondary outcomes

Study Arms (2)

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

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

Device: Sham RIPC

Interventions

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

Disposable sterile thigh tourniquet

Also known as: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
RIPC
Sham RIPCDEVICE

Disposable sterile thigh tourniquet

Also known as: VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1
Sham RIPC

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

PainAcute Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Scott Miller
Organization
Wake Forest University Health Sciences
scmiller@wakehealth.edu
3367167437

Study Officials

  • Scott A Miller, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 28, 2011

Study Start

June 1, 2011

Primary Completion

April 30, 2016

Study Completion

April 30, 2017

Last Updated

September 5, 2018

Results First Posted

January 12, 2018

Record last verified: 2018-08

Locations

US(1)