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This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery.
Study outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes.
Patients will be divided in the following comparison groups:
Two nonpharmacologic interventions have shown promise in treatment of chronic pain. Afferent Vagus nerve simulation (VNS) can modulate nociception, even though the exact mechanism is unclear. Clinically, it has found uses in chronic pain as well as early evidence of potential use in postoperative pain. Alternatively, transcranial direct current stimulation (tDCS) is a form of non-invasive and polarity-specific technique of modulating neuronal circuitry using a weak electric current delivered by a battery. tDCS has also been shown to modulate chronic pain and has been shown to produce EEG signatures similar to those seen in states of adequate intraoperative analgesia.
This study seeks to evaluate the efficacy of tDCS and VNS in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups:
Patient's vital signs and pain level will be obtained before the procedure and after. Patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group +/+ | Experimental | Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. |
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| Group +/- | Active Comparator | Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. |
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| Group -/+ | Active Comparator | Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. |
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| Group -/- | Sham Comparator | Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active transcranial direct current stimulation | Device | Ten minutes of active transcranial direct current stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain levels using Numerical Rating Scale | Numerical Rating Scale (NRS) from 0-10. 0 being no pain, and 10 being the worse pain patient has experienced. | Immediately before the intervention and immediately after the intervention. |
| Pain levels using the Verbal Rating Scale | Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain. | Immediately before the intervention and immediately after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital Signs: Blood pressure. | Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the blood pressure in mmHg. A high score (higher than 130/80) will indicate a bad outcome. | Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul S. Garcia, MD PhD | Contact | 212-304-7523 | pg2618@cumc.columbia.edu | |
| Oriana Lujan, MD | Contact | 212-3047523 | ol2274@cumc.columbia.edu |
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Data will be shared in aggregate form. There is no plan to share individual participant data (IPD) with researchers not involved with the study design. Several posthoc analyses are being planned for retrospective analysis of the data obtained.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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This is a parallel-group, double blinded, randomized trial where 200 subjects will be randomized following a 2x2 structure.
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Patients will be assigned a Study ID that will determine the assigned procedure. At the study's completion the blind will be broken, and data will be turned over for analysis.
| Active vagus nerve stimulation | Device | Ten minutes of active vagus nerve stimulation |
|
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| Sham transcranial direct current stimulation | Other | Ten minutes of sham tDCS |
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| Sham vagus nerve stimulation | Other | Ten minutes of sham VNS |
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| Vital Signs: Heart rate |
Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the heart rate before the intervention and after. A result higher than what is physiologic normal (100) will indicate a bad outcome. |
| Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention. |
| Opioid consumption | Patients that stay in hospital after surgery will be evaluated for opioid consumption from medical record. | 24 hours after surgery |
| Time from surgery to discharge | Investigator will measure how long does the patient stay in the hospital after surgery in number of days. | From the date of the patient's surgery until the day of the discharge, up to 2 month. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |