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Remote Ischemic PreConditioning Effect on Postsurgical Pain (RIPCEPP)

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ClinicalTrials.gov Identifier: NCT01383317
Recruitment Status : Completed
First Posted : June 28, 2011
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Device: Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
Device: Sham RIPC

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet

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

Sham RIPC: Disposable sterile thigh tourniquet


Participant Flow:   Overall Study
    RIPC   Sham RIPC
STARTED   29   35 
COMPLETED   26   33 
NOT COMPLETED   3   2 
Lost to Follow-up                2                1 
Death                1                0 
Adverse Event                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1): Disposable sterile thigh tourniquet

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

Sham RIPC: Disposable sterile thigh tourniquet

Total Total of all reporting groups

Baseline Measures
   RIPC   Sham RIPC   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   35   64 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.03  (11.43)   59.82  (10.62)   55.52  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19  65.5%      21  60.0%      40  62.5% 
Male      10  34.5%      14  40.0%      24  37.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   6.9%      10  28.6%      12  18.8% 
White      23  79.3%      18  51.4%      41  64.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      4  13.8%      7  20.0%      11  17.2% 


  Outcome Measures

1.  Primary:   Comparison of Pain Intensity and Unpleasantness Postoperatively   [ Time Frame: Postoperative day 1 and postoperative day 2 ]

2.  Secondary:   Opioid Consumption   [ Time Frame: Postoperative day 1 and postoperative day 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Consumption of Nonopioid Analgesics   [ Time Frame: Postoperative day 1 and postoperative day 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Scott Miller
Organization: Wake Forest University Health Sciences
phone: 3367167437
e-mail: scmiller@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01383317     History of Changes
Other Study ID Numbers: 00016978
First Submitted: June 2, 2011
First Posted: June 28, 2011
Results First Submitted: December 15, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018