Pain, Postoperative
Conditions
Keywords
Postoperative pain, Rhinoplasty
Brief summary
The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications . Additionally, the study will also seek to track: 1. The total number of pills each patients consume from the prescribed 5 day regimen. 2. Any associated side effects. 3. Additional pain medications prescribed in case of inadequate pain control, postoperatively.
Detailed description
From this study, the investigators hope to learn the following: 1. Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs? 2. If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for? 3. What are the common side effect profiles of the included drugs? In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.
Interventions
Opioid Analgesics
DRUGTylenol 325Mg Caplet
Non opioid analgesics
DRUGIbuprofen 200 mg
Non opioid analgesics
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum age of 18 years * Able to speak and understand english. * Undergoing rhinoplasty for cosmetic purposes * Undergoing rhinoplasty for treatment of nasal obstruction
Exclusion criteria
* Less than 18 years of age * Cannot speak and understand english * Patients who have undergone nasal surgery in the past * Patients not undergoing nasal surgery * Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center. * Patients with any known allergies to the class of pain medications used in the study. Please note: Any person interested in this clinical trial should contact the Facial Plastic and Reconstructive Surgery clinic at (650) 736 - 3223 to schedule a consultation with Dr. Sam P. Most to assess their eligibility for the trial. Please note, enrolling in the clinical trial will not entitle the participant to a waiver of charges associated with undergoing nasal surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) | 5 days post-operative [up to approximately 5 weeks post-baseline] | Self reported pain intensity at every prescribed dose averaged over a period of 5 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Tramadol Doses Utilized | 5 days | — |
| Number Patients Who Reported Adequate Pain Control | 5 days | — |
| Side Effects of Pain Medications | 5 days | Self reported side effects of prescribed medications according to response options. Participants may have reported more than one side-effect. Commonly experienced medication side-effects would not necessarily be considered to be adverse events. |
| Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | Baseline and post-operative follow-up (up to an average of 12 months following procedure) | The SCHNOS-O (obstructive) and SCHNOS-C (Cosmesis) scores were rated from 0 to 100 (higher scores correspond to worse obstruction or cosmesis). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. |
| Number of Study Drugs (Doses) Utilized | 5 days | Use of any study medication, excluding tramadol. |
| Visual Analog Scale-Aesthetic (VAS-A) | Baseline and post-operative follow-up (up to an average of 12 months following procedure) | Patient's perceived aesthetic appearance was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'completely dissatisfied with nasal appearance' and '10' indicated 'the highest possible satisfaction with nasal appearance'). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. |
| Eyelid Edema Score | Post-operative day 7 | Physician-assessed grading of eyelid edema. Score range: 0 to 4; higher numbers indicating more severe swelling. |
| Ecchymosis Score | Post-operative day 7 | Physician-assessed grading of periorbital ecchymosis extension. Score range: 0 to 4; higher numbers indicating more severe ecchymosis. |
| Subconjunctival Hemorrhage Score | Post-operative day 7 | Physician-assessed grading of subconjunctival hemorrhage. Score range: 0 to 2; higher numbers indicating more severe hemorrhage. |
| Visual Analog Scale-Functional (VAS-F) | Baseline and post-operative follow-up (up to an average of 12 months following procedure) | Patient's perceived severity of their nasal obstruction was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'no nasal obstruction' and '10' indicated 'worst possible nasal obstruction). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from the day of the pre-operative appointment (approximately 2 to 4 weeks prior to procedure) through post-operative day 7. Follow-up data at two time points (\<6 months, and ≥ 6 months) were obtained by chart review.
Pre-assignment details
159 signed informed consent and 141 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Drug Arm A Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total. | 65 |
| Drug Arm B Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total. | 65 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued intervention | 7 | 4 |
Baseline characteristics
| Characteristic | Drug Arm B | Drug Arm A | Total |
|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 12.4 | 30.7 years STANDARD_DEVIATION 8.6 | 32.1 years STANDARD_DEVIATION 10.7 |
| Race/Ethnicity, Customized Asian | 10 Participants | 15 Participants | 25 Participants |
| Race/Ethnicity, Customized Latino/ Hispanic | 10 Participants | 6 Participants | 16 Participants |
| Race/Ethnicity, Customized White | 45 Participants | 44 Participants | 89 Participants |
| Region of Enrollment United States | 65 Participants | 65 Participants | 130 Participants |
| Sex: Female, Male Female | 52 Participants | 48 Participants | 100 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 65 |
Outcome results
Primary
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)
Self reported pain intensity at every prescribed dose averaged over a period of 5 days.
Time frame: 5 days post-operative [up to approximately 5 weeks post-baseline]
Population: Participants who completed the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug Arm A | Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) | 44 score on a scale | Standard Deviation 14.1 |
| Drug Arm B | Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain) | 41 score on a scale | Standard Deviation 16.3 |
p-value: 0.156t-test, 2 sided
Secondary
Ecchymosis Score
Physician-assessed grading of periorbital ecchymosis extension. Score range: 0 to 4; higher numbers indicating more severe ecchymosis.
Time frame: Post-operative day 7
Population: Participants who completed the intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Drug Arm A | Ecchymosis Score | 0 score on a scale |
| Drug Arm B | Ecchymosis Score | 0 score on a scale |
p-value: 0.195Wilcoxon (Mann-Whitney)
Secondary
Eyelid Edema Score
Physician-assessed grading of eyelid edema. Score range: 0 to 4; higher numbers indicating more severe swelling.
Time frame: Post-operative day 7
Population: Participants who completed the intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Drug Arm A | Eyelid Edema Score | 0 score on a scale |
| Drug Arm B | Eyelid Edema Score | 0 score on a scale |
p-value: 0.378Wilcoxon (Mann-Whitney)
Secondary
Number of Study Drugs (Doses) Utilized
Use of any study medication, excluding tramadol.
Time frame: 5 days
Population: Participants who completed the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug Arm A | Number of Study Drugs (Doses) Utilized | 16 doses | Standard Deviation 9.5 |
| Drug Arm B | Number of Study Drugs (Doses) Utilized | 19 doses | Standard Deviation 9.9 |
p-value: 0.112t-test, 2 sided
Secondary
Number of Tramadol Doses Utilized
Time frame: 5 days
Population: Participants who completed the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug Arm A | Number of Tramadol Doses Utilized | 1 doses | Standard Deviation 2.5 |
| Drug Arm B | Number of Tramadol Doses Utilized | 2.0 doses | Standard Deviation 3.7 |
p-value: 0.803t-test, 2 sided
Secondary
Number Patients Who Reported Adequate Pain Control
Time frame: 5 days
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug Arm A | Number Patients Who Reported Adequate Pain Control | No (not adequate) | 4 Participants |
| Drug Arm A | Number Patients Who Reported Adequate Pain Control | Yes (adequate) | 61 Participants |
| Drug Arm B | Number Patients Who Reported Adequate Pain Control | No (not adequate) | 2 Participants |
| Drug Arm B | Number Patients Who Reported Adequate Pain Control | Yes (adequate) | 63 Participants |
p-value: 0.403Chi-squared
Secondary
Side Effects of Pain Medications
Self reported side effects of prescribed medications according to response options. Participants may have reported more than one side-effect. Commonly experienced medication side-effects would not necessarily be considered to be adverse events.
Time frame: 5 days
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Drug Arm A | Side Effects of Pain Medications | Itchiness | 14 Participants |
| Drug Arm A | Side Effects of Pain Medications | Bleeding | 30 Participants |
| Drug Arm A | Side Effects of Pain Medications | Constipation | 22 Participants |
| Drug Arm A | Side Effects of Pain Medications | Headache | 9 Participants |
| Drug Arm A | Side Effects of Pain Medications | Nausea | 17 Participants |
| Drug Arm A | Side Effects of Pain Medications | Other | 7 Participants |
| Drug Arm A | Side Effects of Pain Medications | Dizziness | 41 Participants |
| Drug Arm B | Side Effects of Pain Medications | Other | 3 Participants |
| Drug Arm B | Side Effects of Pain Medications | Nausea | 13 Participants |
| Drug Arm B | Side Effects of Pain Medications | Constipation | 19 Participants |
| Drug Arm B | Side Effects of Pain Medications | Dizziness | 31 Participants |
| Drug Arm B | Side Effects of Pain Medications | Bleeding | 28 Participants |
| Drug Arm B | Side Effects of Pain Medications | Headache | 8 Participants |
| Drug Arm B | Side Effects of Pain Medications | Itchiness | 2 Participants |
Comparison: Difference between-groups in constipationp-value: 0.571Chi-squared
Comparison: Difference between-groups in nauseap-value: 0.405Chi-squared
Comparison: Difference between-groups in itchinessp-value: 0.001Fisher Exact
Comparison: Difference between-groups in dizzinessp-value: 0.078Chi-squared
Comparison: Difference between-groups in bleedingp-value: 0.724Chi-squared
Comparison: Difference between-groups in headachep-value: 0.795Chi-squared
Comparison: Difference between-groups in other side effectsp-value: 0.188Fisher Exact
Secondary
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire
The SCHNOS-O (obstructive) and SCHNOS-C (Cosmesis) scores were rated from 0 to 100 (higher scores correspond to worse obstruction or cosmesis). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Time frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug Arm A | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | SCHNOS-O (pre-operative) | 40.0 score on a scale | Standard Deviation 33.2 |
| Drug Arm A | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | Change in SCHNOS-O (post-operative) | -25.7 score on a scale | Standard Deviation 35 |
| Drug Arm A | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | SCHNOS-C (pre-operative) | 54.0 score on a scale | Standard Deviation 29 |
| Drug Arm A | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | Change in SCHNOS-C (post-operative) | -39.6 score on a scale | Standard Deviation 30.7 |
| Drug Arm B | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | Change in SCHNOS-C (post-operative) | -36.0 score on a scale | Standard Deviation 34.2 |
| Drug Arm B | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | SCHNOS-O (pre-operative) | 41.0 score on a scale | Standard Deviation 36.1 |
| Drug Arm B | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | SCHNOS-C (pre-operative) | 54.0 score on a scale | Standard Deviation 26.4 |
| Drug Arm B | Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire | Change in SCHNOS-O (post-operative) | -23.4 score on a scale | Standard Deviation 41.9 |
Comparison: Difference in change in SCHNOS-Op-value: 0.7318t-test, 2 sided
Comparison: Difference in change in SCHNOS-Cp-value: 0.5267t-test, 2 sided
Secondary
Subconjunctival Hemorrhage Score
Physician-assessed grading of subconjunctival hemorrhage. Score range: 0 to 2; higher numbers indicating more severe hemorrhage.
Time frame: Post-operative day 7
Population: Participants who completed the intervention.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Drug Arm A | Subconjunctival Hemorrhage Score | 0 score on a scale |
| Drug Arm B | Subconjunctival Hemorrhage Score | 0 score on a scale |
p-value: 0.682Wilcoxon (Mann-Whitney)
Secondary
Visual Analog Scale-Aesthetic (VAS-A)
Patient's perceived aesthetic appearance was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'completely dissatisfied with nasal appearance' and '10' indicated 'the highest possible satisfaction with nasal appearance'). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Time frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug Arm A | Visual Analog Scale-Aesthetic (VAS-A) | Pre-operative | 3.0 score on a scale | Standard Deviation 2.3 |
| Drug Arm A | Visual Analog Scale-Aesthetic (VAS-A) | Post-operative (change) | -1.5 score on a scale | Standard Deviation 2.7 |
| Drug Arm B | Visual Analog Scale-Aesthetic (VAS-A) | Pre-operative | 3.0 score on a scale | Standard Deviation 2.5 |
| Drug Arm B | Visual Analog Scale-Aesthetic (VAS-A) | Post-operative (change) | -1.2 score on a scale | Standard Deviation 3.1 |
Comparison: Difference in change in VAS-Ap-value: 0.5351t-test, 2 sided
Secondary
Visual Analog Scale-Functional (VAS-F)
Patient's perceived severity of their nasal obstruction was self-graded using a 10-cm-long visual analogue scale ('0' indicated 'no nasal obstruction' and '10' indicated 'worst possible nasal obstruction). Not all 130 patients had a postoperative score at both time follow-up intervals (\<6 months, and ≥ 6 months, obtained by chart review), thus a mean postoperative score (SD) was calculated for each treatment group accounting for both intervals.
Time frame: Baseline and post-operative follow-up (up to an average of 12 months following procedure)
Population: Participants who completed the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Drug Arm A | Visual Analog Scale-Functional (VAS-F) | Pre-operative | 4.0 score on a scale | Standard Deviation 3.1 |
| Drug Arm A | Visual Analog Scale-Functional (VAS-F) | Post-operative (change) | -1.8 score on a scale | Standard Deviation 3 |
| Drug Arm B | Visual Analog Scale-Functional (VAS-F) | Pre-operative | 4.0 score on a scale | Standard Deviation 3.1 |
| Drug Arm B | Visual Analog Scale-Functional (VAS-F) | Post-operative (change) | -1.8 score on a scale | Standard Deviation 3.5 |
Comparison: Difference in change in VAS-Fp-value: 0.9158t-test, 2 sided