Pain
Conditions
Keywords
Remote Ischemic Preconditioning, Acute Pain
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.
Interventions
DEVICEThigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)
Disposable sterile thigh tourniquet
DEVICESham RIPC
Disposable sterile thigh tourniquet
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 30-80 2. Undergoing elective open intra-peritoneal surgery 3. Able to provide written informed consent to participate 4. Laparoscopic abdominal surgery
Exclusion criteria
1. Ongoing Workman's Compensation claim 2. \>50mg/day of oral morphine or morphine equivalent 3. Currently being treated for lower extremity DVT 4. Known intracranial hypertension (not excluding patients with a functioning VP shunt) 5. Known Hypercoagulable state (e.g. factor V Leiden, protein s or c deficiency) 6. Ongoing localized thigh pain 7. Planned epidural analgesia 8. Pregnancy 9. Any DSM IV-R Axis I psychotic disorders 10. Unable to understand English 11. Unable to understand the consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Pain Intensity and Unpleasantness Postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of Nonopioid Analgesics | Postoperative day 1 and postoperative day 2 | 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 | Postoperative day 1 and postoperative day 2 | Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded. |
| Level of Sedation | Postoperative day 1 and postoperative day 2 | 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. |
| Number of Participants That Consumed Opioids | Postoperative day 1 and postoperative day 2 | All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given. |
| Leg Pain at 48 Hours | postoperative day 2 | Number of participants that had leg pain at 48 hours. |
| Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | Postoperative day 1 and postoperative day 2 | Participants were questioned to see if they knew what interventional group they belonged to. |
| Pain Unpleasantness | Postoperative day 1 and postoperative day 2 | 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. |
| McGill Pain Sensory | Postoperative day 1 and postoperative day 2 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| 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 | 35 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Sham RIPC | Total | RIPC |
|---|---|---|---|
| Age, Continuous | 59.82 years STANDARD_DEVIATION 10.62 | 55.52 years STANDARD_DEVIATION 11.6 | 51.03 years STANDARD_DEVIATION 11.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 12 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) White | 18 Participants | 41 Participants | 23 Participants |
| Sex: Female, Male Female | 21 Participants | 40 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 24 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 35 |
| serious Total, serious adverse events | 0 / 29 | 0 / 35 |
Outcome results
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.
Time frame: Postoperative day 1 and postoperative day 2
Population: Data was only collected for participants that were alert and conscious.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RIPC | Comparison of Pain Intensity and Unpleasantness Postoperatively | POD 1 | 4.82 units on a scale | Standard Deviation 0.71 |
| RIPC | Comparison of Pain Intensity and Unpleasantness Postoperatively | POD 2 | 4.05 units on a scale | Standard Deviation 3.08 |
| Sham RIPC | Comparison of Pain Intensity and Unpleasantness Postoperatively | POD 1 | 4.83 units on a scale | Standard Deviation 0.62 |
| Sham RIPC | Comparison of Pain Intensity and Unpleasantness Postoperatively | POD 2 | 4.81 units on a scale | Standard Deviation 3.14 |
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.
Time frame: Postoperative day 1 and postoperative day 2
Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RIPC | Consumption of Nonopioid Analgesics | POD 1 | 19 Participants |
| RIPC | Consumption of Nonopioid Analgesics | POD 2 | 17 Participants |
| Sham RIPC | Consumption of Nonopioid Analgesics | POD 1 | 18 Participants |
| Sham RIPC | Consumption of Nonopioid Analgesics | POD 2 | 21 Participants |
Secondary
Leg Pain at 48 Hours
Number of participants that had leg pain at 48 hours.
Time frame: postoperative day 2
Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIPC | Leg Pain at 48 Hours | 4 Participants |
| Sham RIPC | Leg Pain at 48 Hours | 1 Participants |
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.
Time frame: Postoperative day 1 and postoperative day 2
Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RIPC | Level of Sedation | POD 1 | 2.29 units on a scale | Standard Deviation 0.85 |
| RIPC | Level of Sedation | POD 2 | 2.11 units on a scale | Standard Deviation 0.65 |
| Sham RIPC | Level of Sedation | POD 1 | 2.15 units on a scale | Standard Deviation 0.75 |
| Sham RIPC | Level of Sedation | POD 2 | 1.95 units on a scale | Standard Deviation 0.39 |
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.
Time frame: Postoperative day 1 and postoperative day 2
Population: Population differs from participant flow, because some participants in each group did not complete the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RIPC | McGill Pain Sensory | POD 1 | 11.71 units on a scale | Standard Deviation 9.36 |
| RIPC | McGill Pain Sensory | POD 2 | 7.14 units on a scale | Standard Deviation 3.18 |
| Sham RIPC | McGill Pain Sensory | POD 1 | 12.73 units on a scale | Standard Deviation 7.17 |
| Sham RIPC | McGill Pain Sensory | POD 2 | 12.82 units on a scale | Standard Deviation 12.21 |
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.
Time frame: Postoperative day 1 and postoperative day 2
Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RIPC | Number of Participants That Consumed Opioids | POD 1 | 20 Participants |
| RIPC | Number of Participants That Consumed Opioids | POD 2 | 19 Participants |
| Sham RIPC | Number of Participants That Consumed Opioids | POD 1 | 24 Participants |
| Sham RIPC | Number of Participants That Consumed Opioids | POD 2 | 22 Participants |
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.
Time frame: Postoperative day 1 and postoperative day 2
Population: Data was not collected on some participants in both groups because they refused to answer or they were discharged.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RIPC | Pain Unpleasantness | POD 1 | 4.43 units on a scale | Standard Deviation 3.27 |
| RIPC | Pain Unpleasantness | POD 2 | 3.52 units on a scale | Standard Deviation 3.46 |
| Sham RIPC | Pain Unpleasantness | POD 1 | 5.18 units on a scale | Standard Deviation 3.7 |
| Sham RIPC | Pain Unpleasantness | POD 2 | 4.54 units on a scale | Standard Deviation 3.47 |
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.
Time frame: Postoperative day 1 and postoperative day 2
Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RIPC | Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | Unsure/Unknown | 20 Participants |
| RIPC | Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | RIPC | 1 Participants |
| RIPC | Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | Sham | 2 Participants |
| Sham RIPC | Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | Unsure/Unknown | 20 Participants |
| Sham RIPC | Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | RIPC | 0 Participants |
| Sham RIPC | Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo | Sham | 0 Participants |
Secondary
Use of Antiemetics
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
Population: Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RIPC | Use of Antiemetics | 25 Participants |
| Sham RIPC | Use of Antiemetics | 21 Participants |