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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1) | Device | Disposable sterile thigh tourniquet |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott A Miller, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Sham RIPC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was only collected for participants that were alert and conscious. | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 1 and postoperative day 2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Miller | Wake Forest University Health Sciences | 3367167437 | scmiller@wakehealth.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham RIPC | Device | Disposable sterile thigh tourniquet |
|
|
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 |
| Adverse Event |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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 |
|
|
| Secondary | 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. | Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged. | Posted | Count of Participants | Participants | Postoperative day 1 and postoperative day 2 |
|
|
|
| Secondary | 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. | Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged. | Posted | Count of Participants | Participants | Postoperative day 1 and postoperative day 2 |
|
|
|
| Secondary | Use of Antiemetics | Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded. | Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged. | Posted | Count of Participants | Participants | Postoperative day 1 and postoperative day 2 |
|
|
|
| Secondary | 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. | Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged. | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 1 and postoperative day 2 |
|
|
|
| Secondary | 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. | Population differs from participant flow, because some participants in each group did not complete the assessment. | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 1 and postoperative day 2 |
|
|
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| Secondary | Leg Pain at 48 Hours | Number of participants that had leg pain at 48 hours. | Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged. | Posted | Count of Participants | Participants | postoperative day 2 |
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| Secondary | 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. | Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged. | Posted | Count of Participants | Participants | Postoperative day 1 and postoperative day 2 |
|
|
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| Secondary | 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. | Data was not collected on some participants in both groups because they refused to answer or they were discharged. | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 1 and postoperative day 2 |
|
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| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 | 0 | 35 | 0 | 35 |
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| POD 2 |
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| Sham |
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| POD 2 |
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