Post-Operative Pain
Conditions
Brief summary
The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.
Detailed description
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.
Interventions
DEVICEtDCS
20 minutes of either real or sham stimulation
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 years-75 years of age * surgery at Medical University of South Carolina * at least 2 days of post-operative stay
Exclusion criteria
* history of seizures or epilepsy * family history of seizures * taking any medications shown to lower seizure threshold * metal implants above the waist * pregnant * brain tumors or lesions * pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Controlled Analgesia (PCA) Hydromorphone Usage | Participants were followed for the duration of hospital stay, an average of 48 hours. | The PCA pump usage was downloaded from the PCA pump after discharge from the hospital. |
| Average Pain at Least | Baseline and Discharge | To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain. |
| Average Pain at Worst | Baseline Only | To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain. |
| Average Pain | Baseline Only | To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Real tDCS:Active Comparator tDCS: 20 minutes of either real or sham stimulation | 14 |
| Sham tDCS: Sham Comparator tDCS: 20 minutes of either real or sham stimulation | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Real tDCS:Active Comparator | Total | Sham tDCS: Sham Comparator |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 2.1 | 59.4 years STANDARD_DEVIATION 2.1 | 59.4 years STANDARD_DEVIATION 2.1 |
| 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 | 2 Participants | 4 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 23 Participants | 11 Participants |
| Region of Enrollment United States | 14 participants | 27 participants | 13 participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
Average Pain
To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Time frame: Baseline Only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real tDCS:Active Comparator | Average Pain | 7.0 units on a scale | Standard Deviation 1.5 |
| Sham tDCS: Sham Comparator | Average Pain | 6.3 units on a scale | Standard Deviation 1.4 |
Primary
Average Pain at Least
To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Time frame: Baseline and Discharge
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real tDCS:Active Comparator | Average Pain at Least | Baseline | 4.5 units on a scale | Standard Deviation 2.5 |
| Real tDCS:Active Comparator | Average Pain at Least | Discharge | 3.2 units on a scale | Standard Deviation 2.2 |
| Sham tDCS: Sham Comparator | Average Pain at Least | Baseline | 3.5 units on a scale | Standard Deviation 1.6 |
| Sham tDCS: Sham Comparator | Average Pain at Least | Discharge | 3.5 units on a scale | Standard Deviation 1.6 |
Primary
Average Pain at Worst
To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Time frame: Baseline Only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real tDCS:Active Comparator | Average Pain at Worst | 8.9 units on a scale | Standard Deviation 1.2 |
| Sham tDCS: Sham Comparator | Average Pain at Worst | 8.0 units on a scale | Standard Deviation 2.4 |
Primary
Patient Controlled Analgesia (PCA) Hydromorphone Usage
The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
Time frame: Participants were followed for the duration of hospital stay, an average of 48 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real tDCS:Active Comparator | Patient Controlled Analgesia (PCA) Hydromorphone Usage | 12.6 milligrams of hydromorphone | Standard Deviation 9.9 |
| Sham tDCS: Sham Comparator | Patient Controlled Analgesia (PCA) Hydromorphone Usage | 16.5 milligrams of hydromorphone | Standard Deviation 12.7 |