Acute Pain, Anesthesia, Intratracheal, Anesthesia, Intravenous, Chronic Pain, Hernia
Conditions
Brief summary
Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.
Interventions
DRUGPropofol
DRUGSevoflurane
DRUGRemifentanil
DRUGKetamine
Sponsors
VA Pittsburgh Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All male patients undergoing herniorrhaphy surgery that requires general anesthesia.
Exclusion criteria
* Subjects unable to communicate directly with the investigators, due to being non-English speaking, loss of hearing, or incompetence. * A history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization. * Pain-related disorders such as fibromyalgia or other chronic pain syndromes. * Emergency surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score, Chronic | 1 month, 3 months, 6 months, 12 months | Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score, Acute | 1 day | Acute Pain on Day 1, as measured by the Pain Quality Assessment Scale (PQAS). The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores means worse pain. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BALANCED INHALATIONAL Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)
Sevoflurane
Remifentanil | 6 |
| TIVA-K Total intravenous anesthetic with ketamine
Propofol
Ketamine | 2 |
| TIVA-R Total intravenous anesthetic with remifentanil
Propofol
Remifentanil | 2 |
| Total | 10 |
Baseline characteristics
| Characteristic | BALANCED INHALATIONAL | TIVA-K | TIVA-R | Total |
|---|---|---|---|---|
| Age, Continuous | 65.5 years | 68 years | 73 years | 67.5 years |
| Pain level in PACU | 6 Pain score (0-10) STANDARD_DEVIATION 2.68 | 6.5 Pain score (0-10) STANDARD_DEVIATION 4.95 | 6.5 Pain score (0-10) STANDARD_DEVIATION 3.54 | 6.2 Pain score (0-10) STANDARD_DEVIATION 2.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 2 Participants | 2 Participants | 10 Participants |
| Region of Enrollment United States | 6 participants | 2 participants | 2 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 6 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Pain Score, Chronic
Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain.
Time frame: 1 month, 3 months, 6 months, 12 months
Population: Only 10 subjects were enrolled, and the numbers represented a typical distribution of Inhalational to TIVA use. Because of the low subject numbers, statistical differences between the techniques were not sought.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BALANCED INHALATIONAL | Pain Score, Chronic | 6 Months | 0 score on a scale | Standard Deviation 0 |
| BALANCED INHALATIONAL | Pain Score, Chronic | 12 Months | 0 score on a scale | Standard Deviation 0 |
| BALANCED INHALATIONAL | Pain Score, Chronic | 3 Months | .8 score on a scale | Standard Deviation 1.6 |
| BALANCED INHALATIONAL | Pain Score, Chronic | 1 Month | 1.7 score on a scale | Standard Deviation 2.7 |
| TIVA-K | Pain Score, Chronic | 3 Months | 0 score on a scale | Standard Deviation 0 |
| TIVA-K | Pain Score, Chronic | 6 Months | 0 score on a scale | Standard Deviation 0 |
| TIVA-K | Pain Score, Chronic | 1 Month | 1.5 score on a scale | Standard Deviation 2.1 |
| TIVA-K | Pain Score, Chronic | 12 Months | 0 score on a scale | Standard Deviation 0 |
| TIVA-R | Pain Score, Chronic | 12 Months | 0 score on a scale | Standard Deviation 0 |
| TIVA-R | Pain Score, Chronic | 1 Month | 0 score on a scale | Standard Deviation 0 |
| TIVA-R | Pain Score, Chronic | 3 Months | 0 score on a scale | Standard Deviation 0 |
| TIVA-R | Pain Score, Chronic | 6 Months | 0 score on a scale | Standard Deviation 0 |
Secondary
Pain Score, Acute
Acute Pain on Day 1, as measured by the Pain Quality Assessment Scale (PQAS). The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores means worse pain.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BALANCED INHALATIONAL | Pain Score, Acute | 4.6 score on a scale | Standard Deviation 3.5 |
| TIVA-K | Pain Score, Acute | 9.0 score on a scale | Standard Deviation 0 |
| TIVA-R | Pain Score, Acute | 3.0 score on a scale | Standard Deviation 1.4 |