Acute Pain, Head and Neck Cancer, Postoperative Pain
Conditions
Keywords
oral cavity, oropharynx, hypopharynx and larynx
Brief summary
Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect provider and hospital quality of care. Furthermore, at the core of a healthcare team and healthcare system is the desire to provide patients with the best possible care in order to achieve the best possible outcomes. Providers have the duty to identify areas of needed improvement within the domains of treatment. An area of need that is ubiquitous within medicine is pain control; in this case acute postoperative pain control is the targeted condition. Studies have already shown that better control of acute postoperative pain leads to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient satisfaction and a reduced likelihood of developing chronic pain. Research within the field of pain management has definitively revealed that a combination of different medication regimens can control acute postoperative pain better than narcotics alone. In particular, the medication gabapentin has been shown to improve acute postop pain in many kinds of surgical settings, and it is a safe medication with arguably fewer side effects than narcotics. The investigators know that certain groups of post surgical otolaryngology patients can be at risk for high levels of postoperative pain. Given all of this information, physicians have a responsibility to utilize medications such as gabapentin to do a better job of controlling patient's pain. This investigation is a quality improvement project designed to elucidate the benefits of gabapentin in pain management in patients undergoing surgery of the head and neck mucosal surfaces. It will provide much needed data in an understudied population and ultimately will improve the practice of pain management, patient satisfaction and quality of care delivered in the Barnes otolaryngology department.
Interventions
DRUGGabapentin
DRUGPlacebo
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects undergoing definitive mucosal head and neck resection including oral cavity, oropharynx, larynx, and hypopharynx * At least one night of planned inpatient stay
Exclusion criteria
* Incapable of giving informed consent * Age less than 18 * Glomerular Filtration Rate (GFR) less than 30 * Allergy to gabapentin * Baseline gabapentin or lyrica use * Chronic opioid use for over six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily Narcotic Consumption | Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first. | Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Once on post-op day 2 or day of discharge, whichever comes first | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. |
| Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Once on post-op day 2 or day of discharge, whichever comes first | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. |
| Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | Once on post-op day 2 or day of discharge, whichever comes first | -A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score. |
| Mean Pain With Coughing Score as Measured by VAS | Baseline through post operative day 3 | * Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end. * Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain |
| Mean Pain With Swallowing Score as Measured by VAS | Baseline through post operative day 3 | * Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end. * Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain |
| Mean Pain With Resting Score as Measured by VAS | Baseline through post operative day 3 | * Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end. * Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain |
Countries
United States
Participant flow
Recruitment details
The study opened to participant enrollment on 06/24/2016 and closed to participant enrollment on 06/30/2017.
Pre-assignment details
13 participants were enrolled but withdrew prior to study participation with no medication given. 8 participants withdrew due to patient preference and 5 withdrew due to cancellation of surgery.
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Gabapentin liquid by mouth or per Tube 300mg twice a day | 44 |
| Placebo Placebo liquid by mouth or Per Tube twice a day | 46 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change in surgery plan | 3 | 1 |
| Overall Study | Change to outpatient status | 5 | 1 |
| Overall Study | Delirium | 0 | 1 |
| Overall Study | Nausea | 1 | 0 |
| Overall Study | Remain intubated | 2 | 2 |
| Overall Study | Return to operating room | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Gabapentin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 11.3 | 60.9 years STANDARD_DEVIATION 10 | 61.0 years STANDARD_DEVIATION 10.6 |
| Participant's experience with significant amount of daily pain Daily pain | 3 Participants | 8 Participants | 11 Participants |
| Participant's experience with significant amount of daily pain No daily pain | 40 Participants | 36 Participants | 76 Participants |
| Participant's opinion on effectiveness of narcotic pain medication High effectiveness | 29 Participants | 32 Participants | 61 Participants |
| Participant's opinion on effectiveness of narcotic pain medication Low effectiveness | 8 Participants | 10 Participants | 18 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 44 participants | 46 participants | 90 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 33 Participants | 36 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 1 / 55 |
| other Total, other adverse events | 46 / 55 | 50 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Change in Daily Narcotic Consumption
Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption.
Time frame: Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Change in Daily Narcotic Consumption | 1.60 mg/hour |
| Placebo | Change in Daily Narcotic Consumption | 1.59 mg/hour |
95% CI: [-0.27, 0.94]
Secondary
Mean Pain With Coughing Score as Measured by VAS
* Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end. * Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain
Time frame: Baseline through post operative day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 1 10AM | 36 mm | Standard Deviation 30 |
| Gabapentin | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 2 10AM | 28 mm | Standard Deviation 23.3 |
| Gabapentin | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 1 7AM | 36 mm | Standard Deviation 27.9 |
| Gabapentin | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 2 7PM | 30 mm | Standard Deviation 25.1 |
| Gabapentin | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 1 7PM | 34 mm | Standard Deviation 26.5 |
| Gabapentin | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 3 7AM | 27 mm | Standard Deviation 24.1 |
| Gabapentin | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 2 7AM | 34 mm | Standard Deviation 27 |
| Placebo | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 3 7AM | 39 mm | Standard Deviation 27.1 |
| Placebo | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 1 7AM | 46 mm | Standard Deviation 26.7 |
| Placebo | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 1 10AM | 45 mm | Standard Deviation 28.2 |
| Placebo | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 2 7AM | 39 mm | Standard Deviation 27.6 |
| Placebo | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 2 10AM | 39 mm | Standard Deviation 28.5 |
| Placebo | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 2 7PM | 45 mm | Standard Deviation 29.7 |
| Placebo | Mean Pain With Coughing Score as Measured by VAS | Post-operative Day 1 7PM | 41 mm | Standard Deviation 27.4 |
95% CI: [-0.9, 22.3]
95% CI: [-3.4, 21.6]
95% CI: [-6.1, 18.6]
95% CI: [-7.3, 17.8]
95% CI: [-1.4, 23.8]
95% CI: [-0.1, 29.9]
95% CI: [-2.8, 26]
Secondary
Mean Pain With Resting Score as Measured by VAS
* Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end. * Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain
Time frame: Baseline through post operative day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 1 7PM | 25 mm | Standard Deviation 25.3 |
| Gabapentin | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 2 10AM | 23 mm | Standard Deviation 23.3 |
| Gabapentin | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 1 10AM | 29 mm | Standard Deviation 26.5 |
| Gabapentin | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 2 7PM | 25 mm | Standard Deviation 24.3 |
| Gabapentin | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 2 7AM | 27 mm | Standard Deviation 26.2 |
| Gabapentin | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 3 7AM | 22 mm | Standard Deviation 22.4 |
| Gabapentin | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 1 7AM | 44 mm | Standard Deviation 26.9 |
| Placebo | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 3 7AM | 32 mm | Standard Deviation 26.1 |
| Placebo | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 1 7AM | 46 mm | Standard Deviation 24.9 |
| Placebo | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 1 10AM | 37 mm | Standard Deviation 28.2 |
| Placebo | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 1 7PM | 32 mm | Standard Deviation 25.9 |
| Placebo | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 2 7AM | 32 mm | Standard Deviation 24.5 |
| Placebo | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 2 10AM | 30 mm | Standard Deviation 22.4 |
| Placebo | Mean Pain With Resting Score as Measured by VAS | Post-operative Day 2 7PM | 33 mm | Standard Deviation 25.7 |
95% CI: [-2.9, 20.3]
95% CI: [-4.6, 18.9]
95% CI: [-6.6, 16.8]
95% CI: [-3.6, 18.3]
95% CI: [-5.6, 21.6]
95% CI: [-3.4, 18.3]
95% CI: [-3.5, 23.8]
Secondary
Mean Pain With Swallowing Score as Measured by VAS
* Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end. * Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the \>70 range with severe pain
Time frame: Baseline through post operative day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 1 7PM | 41 mm | Standard Deviation 29.2 |
| Gabapentin | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 2 10AM | 37 mm | Standard Deviation 29.5 |
| Gabapentin | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 1 10AM | 46 mm | Standard Deviation 33.8 |
| Gabapentin | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 2 7PM | 40 mm | Standard Deviation 29.3 |
| Gabapentin | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 2 7AM | 41 mm | Standard Deviation 30.1 |
| Gabapentin | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 3 7AM | 35 mm | Standard Deviation 28 |
| Gabapentin | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 1 7AM | 49 mm | Standard Deviation 32.3 |
| Placebo | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 3 7AM | 52 mm | Standard Deviation 30.5 |
| Placebo | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 1 7AM | 48 mm | Standard Deviation 30.7 |
| Placebo | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 1 10AM | 51 mm | Standard Deviation 31.3 |
| Placebo | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 1 7PM | 52 mm | Standard Deviation 28.5 |
| Placebo | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 2 7AM | 48 mm | Standard Deviation 28.9 |
| Placebo | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 2 10AM | 45 mm | Standard Deviation 29.8 |
| Placebo | Mean Pain With Swallowing Score as Measured by VAS | Post-operative Day 2 7PM | 56 mm | Standard Deviation 29.3 |
95% CI: [-14.7, 11.9]
95% CI: [-8.6, 19.2]
95% CI: [-2.4, 24.2]
95% CI: [-6.6, 20.7]
95% CI: [-6.4, 22.3]
95% CI: [-0.4, 31.7]
95% CI: [0, 33.4]
Secondary
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain
-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.
Time frame: Once on post-op day 2 or day of discharge, whichever comes first
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Never | 0 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Sometimes | 0 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Usually | 5 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Always | 37 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Always | 36 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Never | 0 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Usually | 5 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain | Sometimes | 2 Participants |
Secondary
Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled
-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.
Time frame: Once on post-op day 2 or day of discharge, whichever comes first
Population: The participants who did not answer this question on the survey were not evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | Never | 1 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | Sometimes | 1 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | Usually/Always | 40 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | Never | 0 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | Sometimes | 6 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled | Usually/Always | 37 Participants |
95% CI: [-3, 21]
Secondary
Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control
-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.
Time frame: Once on post-op day 2 or day of discharge, whichever comes first
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Somewhat satisfied | 7 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Somewhat dissatisfied | 0 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Neutral | 2 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Dissatisfied | 3 Participants |
| Gabapentin | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Very satisfied | 30 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Dissatisfied | 2 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Somewhat satisfied | 5 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Very satisfied | 34 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Somewhat dissatisfied | 2 Participants |
| Placebo | Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control | Neutral | 0 Participants |
95% CI: [-15, 11]