Acute Postoperative PainNCT06554067
Effects of tDCS and VNS on Postoperative Analgesia
A study testing Active transcranial direct current stimulation and Active vagus nerve stimulation in people with Acute Postoperative Pain, run by Columbia University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Postoperative Pain
- What is being tested?
- Active transcranial direct current stimulation and Active vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia
Who cannot join
- cardiac bradyarrhythmia: taking beta-blockers;
- patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);
- pregnancy
- history of epilepsy or seizures.
- patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
Patients will be divided in the following comparison groups:
- Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
- Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
- Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
- Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
Read the detailed description
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:
- Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
- Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
- Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
- Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
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.
- Conditions
- Acute Postoperative Pain
- Being tested
- Active transcranial direct current stimulation, Active vagus nerve stimulation, Sham transcranial direct current stimulation, Sham vagus nerve stimulation
- Keywords
- Postoperative pain, Chronic Pain, Transcranial direct current stimulation, Vagus nerve stimulation
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active transcranial direct current stimulationDevice
Also called tDCS
Ten minutes of active transcranial direct current stimulation
Active vagus nerve stimulationDevice
Also called VNS
Ten minutes of active vagus nerve stimulation
Sham transcranial direct current stimulationOther
Ten minutes of sham tDCS
Sham vagus nerve stimulationOther
Ten minutes of sham VNS
| Study group | Role | What they receive |
|---|---|---|
| Group +/+ | Experimental | Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. Receives: Device: Active transcranial direct current stimulation; Device: Active vagus nerve stimulation |
| Group +/- | Active comparator | Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. Receives: Device: Active transcranial direct current stimulation; Other: Sham vagus nerve stimulation |
| Group -/+ | Active comparator | Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. Receives: Device: Active vagus nerve stimulation; Other: Sham transcranial direct current stimulation |
| Group -/- | Sham comparator | Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS. Receives: Other: Sham transcranial direct current stimulation; Other: Sham vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately before the intervention and immediately after the intervention.
Secondary outcomes (4)
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.
Measured: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
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.
Measured: 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.
Measured: 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.
Measured: From the date of the patient's surgery until the day of the discharge, up to 2 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group, double blinded, randomized trial where 200 subjects will be randomized following a 2x2 structure.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Garcia, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554067
- Sponsor's protocol ID
- AAAV2033
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of tDCS and VNS on Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT06554067
- Acronym / sponsor ID
- AAAV2033
- Conditions
- Acute Postoperative Pain
- Keywords
- Postoperative pain, Chronic Pain, Transcranial direct current stimulation, Vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
- Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
- Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
- Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
Detailed description
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:
- Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
- Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
- Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
- Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a parallel-group, double blinded, randomized trial where 200 subjects will be randomized following a 2x2 structure.
| Arm | Type | Receives |
|---|---|---|
| Group +/+ | Experimental | Device: Active transcranial direct current stimulation, Device: Active vagus nerve stimulationGroup +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. |
| Group +/- | Active comparator | Device: Active transcranial direct current stimulation, Other: Sham vagus nerve stimulationGroup +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. |
| Group -/+ | Active comparator | Device: Active vagus nerve stimulation, Other: Sham transcranial direct current stimulationGroup -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. |
| Group -/- | Sham comparator | Other: Sham transcranial direct current stimulation, Other: Sham vagus nerve stimulationGroup -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia
Key exclusion criteria (5 listed)
- cardiac bradyarrhythmia: taking beta-blockers;
- patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);
- pregnancy
- history of epilepsy or seizures.
- patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active transcranial direct current stimulationAlso: tDCSTen minutes of active transcranial direct current stimulation | Device | Group +/+, Group +/- |
| Active vagus nerve stimulationAlso: VNSTen minutes of active vagus nerve stimulation | Device | Group +/+, Group -/+ |
| Sham transcranial direct current stimulationTen minutes of sham tDCS | Other | Group -/+, Group -/- |
| Sham vagus nerve stimulationTen minutes of sham VNS | Other | Group +/-, Group -/- |
Primary outcome
Pain levels using Numerical Rating Scale
Time frame: Immediately before the intervention and immediately after the intervention.
Numerical Rating Scale (NRS) from 0-10. 0 being no pain, and 10 being the worse pain patient has experienced.
Pain levels using the Verbal Rating Scale
Time frame: Immediately before the intervention and immediately after the intervention.
Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain.
4 secondary outcomes
Vital Signs: Blood pressure.
Time frame: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
Vital Signs: Heart rate
Time frame: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
Opioid consumption
Time frame: 24 hours after surgery
Time from surgery to discharge
Time frame: From the date of the patient's surgery until the day of the discharge, up to 2 month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial direct current stimulation and Active vagus nerve stimulation in people with Acute Postoperative Pain, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul S. Garcia, MD PhD (212-304-7523, pg2618@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels using Numerical Rating Scale (time frame: Immediately before the intervention and immediately after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.