Outpatient Surgery, Pain, Postoperative
Conditions
Keywords
Thyroidectomy, Parotidectomy, Tympanoplasty, Mastoidectomy, Septoplasty, Sinus Surgery, Postoperative pain, Outpatient surgery
Brief summary
Patient's pain level and narcotic requirements will be evaluated after routine outpatient Otolaryngology procedures. This will be done by having study participants record their pain level and medication usage from home.
Detailed description
It is routine practice to give narcotic medication after surgery for pain control however the abuse of prescription medications has become the fastest growing drug problem in the United States. Research has shown that post operative pain for some common Ear, Nose, and Throat (ENT) procedures are not severe but there is limited data looking at patient narcotic needs and their usage pattern to help inform physicians on how much to prescribe. The objective of this study is to evaluate patient pain level in the immediate post-operative period and quantify pain medication usage in patients who undergo outpatient ENT surgeries. Patients who undergo the following procedures will be invited to participate: thyroidectomy, parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen for pain control and the narcotic medication for breakthrough. Patients will fill out a data sheet for 7 days recording their pain level three times per day as well as pain medication usage for each day. This will be collected on their first clinic visit after surgery at which point the patient's involvement is completed.
Interventions
DRUGNorco
Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
DRUGIbuprofen
Ibuprofen as first line therapy every 6 hours as needed for pain control
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
Patients undergoing one of the following outpatient procedure: * Septoplasty * Unilateral or Bilateral Functional endoscopic sinus surgery * Tympanomastoidectomy * Tympanoplasty * Total or Partial Thyroidectomy * Parathyroidectomy * Parotidectomy. * Age \>18 years and \< 89 years
Exclusion criteria
* Age \< 18 years or \> 89 years * Post operative hospital admission * Allergy to Hydrocodone * Allergy or contraindication to Ibuprofen or NSAIDs * Pregnancy * Hepatic disease * Chronic kidney disease * Sickle cell anemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Usage | First 7 days after surgery | The average number of narcotic pills needed or used for pain control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Level | Average reported pain for first 7 days after surgery | The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain. |
| Ibuprofen Usage | First 7 days after surgery | The average number of ibuprofen pills needed or used for pain control |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Norco and Ibuprofen This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention.
If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.
Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control | 56 |
| Ibuprofen and Norco This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention.
If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.
Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control | 52 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 28 | 30 |
| Overall Study | Protocol Violation | 13 | 6 |
Baseline characteristics
| Characteristic | Norco and Ibuprofen | Ibuprofen and Norco | Total |
|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 17 | 52.9 years STANDARD_DEVIATION 17 | 53 years STANDARD_DEVIATION 17 |
| Chronic Pain | 15 Participants | 11 Participants | 26 Participants |
| Prior Narcotic use | 4 Participants | 3 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Revision Surgery | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Female | 37 Participants | 26 Participants | 63 Participants |
| Sex: Female, Male Male | 19 Participants | 26 Participants | 45 Participants |
| Surgery Length | 94.4 minutes STANDARD_DEVIATION 43 | 95.3 minutes STANDARD_DEVIATION 43 | 94.8 minutes STANDARD_DEVIATION 42.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 88 |
| other Total, other adverse events | 4 / 97 | 3 / 88 |
| serious Total, serious adverse events | 0 / 97 | 0 / 88 |
Outcome results
Primary
Narcotic Usage
The average number of narcotic pills needed or used for pain control
Time frame: First 7 days after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Norco and Ibuprofen | Narcotic Usage | 4.9 Pills |
| Ibuprofen and Norco | Narcotic Usage | 2.0 Pills |
Secondary
Ibuprofen Usage
The average number of ibuprofen pills needed or used for pain control
Time frame: First 7 days after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Norco and Ibuprofen | Ibuprofen Usage | 4.5 pills |
| Ibuprofen and Norco | Ibuprofen Usage | 7.7 pills |
Secondary
Patient Pain Level
The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain.
Time frame: Average reported pain for first 7 days after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Norco and Ibuprofen | Patient Pain Level | 3.5 Scores on a scale |
| Ibuprofen and Norco | Patient Pain Level | 2.8 Scores on a scale |