Pain Management
Conditions
Brief summary
Opioids are prescribed for moderate to severe pain disorders; however, there are contraindications and side effects that are common to all opioids. The investigators hypothesize using regional anesthetic during sinus surgery will reduce surgical pain, therefore decreasing the need for post-operative opioid medication. The primary of objective is to determine if a long-acting local regional anesthetic applied during a surgery will reduce post-operative oral opioid usage.
Detailed description
Opioid analgesics are prescribed for moderate to severe acute pain; however, there are contraindications, cautions, and side effects that are common with all opioids. Dependence and tolerance are also likely with regular opioid use, resulting in the current nationwide opioid epidemic. In Alabama alone, there were 343 opioid-related overdose deaths in 2016, 124 of which were related to prescription opioids. Alabama providers have the highest prescribing rate in the country, nearly twice the national rate, per the NIH/NIDA website. In 2015, the Centers for Disease Control (CDC) released prescribing guidelines relating to chronic pain, and in 2018 Alabama's Blue Cross/Blue Shield insurance group limited the supply of opioids allowed to their members to 7 days. There is currently no clinical guideline for prescribing post operative opioid medications for functional endoscopic sinus surgery (FESS). A 2018 survey documenting prescribing patterns by 168 members of the American Rhinologic Society found that most physicians who participated prescribed, on average, 27 opioid pain pills for patients after surgery. Prior studies have been performed to help decrease the pain patient's feel after sinus surgery. Haytoglu in 2016 revealed that adding non-absorbable sinus packs loaded with local anesthetics such as bupivacaine achieved less pain values and improved patient satisfaction scores. Given this current data the investigators believe injecting patients with a long acting analgesic during the procedure will help reduce post-operative pain. If the investigators can decrease the amount of pain patients have in the post-operative period, they can theoretically decrease the number of opioid pain pills prescribed. The investigators plan to also track the number of opioid pills consumed by patients in the post-operative period to obtain a somewhat uniform prescribing pattern within surgeons.
Interventions
20 mL of 1.3% bupivacaine
2 mg dexamethasone
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 18 years or older * Able to sign informed consent form * Able to comply with all study procedures and availability for the duration of the study * Able to speak English * Diagnosis of chronic rhinosinusitis * Scheduled to receive functional endoscopic sinus surgery (FESS) at UAB
Exclusion criteria
* Current use of opioid medication * Known allergic reactions to components of the study intervention * History of IV drug use or abuse * History of opioid abuse * History of chronic pain disorder * Treatment with another investigational drug or other intervention within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Pain Control | 10 days | Self-report of pain score on a scale of 0 to 10, with 0 being no pain and 10 being worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Medication Use | 10 days | Amount of opioid medication used, based on pill count |
Countries
United States
Participant flow
Pre-assignment details
No patients were excluded prior to assignment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group 20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure
Bupivacaine: 20 mL of 1.3% bupivacaine
Dexamethasone: 2 mg dexamethasone | 16 |
| Control Group No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 9 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 36.73 years STANDARD_DEVIATION 13.1 | 48.69 years STANDARD_DEVIATION 17.79 | 42.90 years STANDARD_DEVIATION 13.59 |
| Anxiety/Depression No | 14 Participants | 11 Participants | 25 Participants |
| Anxiety/Depression Yes | 1 Participants | 5 Participants | 6 Participants |
| Body Mass Index | 31.71 kg/m^2 STANDARD_DEVIATION 11.1 | 31.19 kg/m^2 STANDARD_DEVIATION 7.66 | 31.44 kg/m^2 STANDARD_DEVIATION 9.32 |
| Diabetes No | 12 Participants | 15 Participants | 27 Participants |
| Diabetes Yes | 3 Participants | 1 Participants | 4 Participants |
| Migraine No | 12 Participants | 15 Participants | 27 Participants |
| Migraine Yes | 3 Participants | 1 Participants | 4 Participants |
| Obstructive Sleep Apnea No | 12 Participants | 14 Participants | 26 Participants |
| Obstructive Sleep Apnea Yes | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 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 | 10 Participants | 13 Participants | 23 Participants |
| Region of Enrollment United States | 15 participants | 16 participants | 31 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 0 / 16 | 0 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
Participant Pain Control
Self-report of pain score on a scale of 0 to 10, with 0 being no pain and 10 being worst pain imaginable
Time frame: 10 days
Population: Both groups were analyzed on the average number of pain pills taken during the post-operative time and average pain scores per day postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Participant Pain Control | POD 2 | 4.06 units on a scale | Standard Deviation 1.84 |
| Treatment Group | Participant Pain Control | POD 6 | 3.00 units on a scale | Standard Deviation 2.58 |
| Treatment Group | Participant Pain Control | POD1 | 4.63 units on a scale | Standard Deviation 1.86 |
| Treatment Group | Participant Pain Control | POD 7 | 2.56 units on a scale | Standard Deviation 2.45 |
| Treatment Group | Participant Pain Control | POD 4 | 3.38 units on a scale | Standard Deviation 1.93 |
| Treatment Group | Participant Pain Control | POD 8 | 2.13 units on a scale | Standard Deviation 2.45 |
| Treatment Group | Participant Pain Control | POD 0 | 4.5 units on a scale | Standard Deviation 2.83 |
| Treatment Group | Participant Pain Control | POD 9 | 2.19 units on a scale | Standard Deviation 2.34 |
| Treatment Group | Participant Pain Control | POD 5 | 3.00 units on a scale | Standard Deviation 2.42 |
| Treatment Group | Participant Pain Control | POD 10 | 2.13 units on a scale | Standard Deviation 2.5 |
| Treatment Group | Participant Pain Control | POD 3 | 4.13 units on a scale | Standard Deviation 1.46 |
| Control Group | Participant Pain Control | POD 10 | 1.27 units on a scale | Standard Deviation 2.21 |
| Control Group | Participant Pain Control | POD 3 | 3.20 units on a scale | Standard Deviation 2.01 |
| Control Group | Participant Pain Control | POD 0 | 5.87 units on a scale | Standard Deviation 2.85 |
| Control Group | Participant Pain Control | POD1 | 5.00 units on a scale | Standard Deviation 1.96 |
| Control Group | Participant Pain Control | POD 2 | 4.13 units on a scale | Standard Deviation 1.89 |
| Control Group | Participant Pain Control | POD 4 | 2.67 units on a scale | Standard Deviation 2.02 |
| Control Group | Participant Pain Control | POD 5 | 2.33 units on a scale | Standard Deviation 1.76 |
| Control Group | Participant Pain Control | POD 6 | 2.2 units on a scale | Standard Deviation 1.7 |
| Control Group | Participant Pain Control | POD 7 | 2.13 units on a scale | Standard Deviation 1.6 |
| Control Group | Participant Pain Control | POD 8 | 1.67 units on a scale | Standard Deviation 1.76 |
| Control Group | Participant Pain Control | POD 9 | 1.73 units on a scale | Standard Deviation 2.22 |
Opioid Medication Use
Amount of opioid medication used, based on pill count
Time frame: 10 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group | Opioid Medication Use | POD 2 | 1.69 pills consumed | Standard Deviation 1.66 |
| Treatment Group | Opioid Medication Use | POD 3 | 1.63 pills consumed | Standard Deviation 1.45 |
| Treatment Group | Opioid Medication Use | POD 4 | 0.97 pills consumed | Standard Deviation 1.49 |
| Treatment Group | Opioid Medication Use | POD 9 | 0.31 pills consumed | Standard Deviation 0.6 |
| Treatment Group | Opioid Medication Use | POD 10 | 0.31 pills consumed | Standard Deviation 0.6 |
| Treatment Group | Opioid Medication Use | POD 0 | 1.38 pills consumed | Standard Deviation 1.03 |
| Treatment Group | Opioid Medication Use | POD 1 | 2.31 pills consumed | Standard Deviation 1.4 |
| Treatment Group | Opioid Medication Use | POD 5 | 0.594 pills consumed | Standard Deviation 1.11 |
| Treatment Group | Opioid Medication Use | POD 6 | 0.50 pills consumed | Standard Deviation 1.09 |
| Treatment Group | Opioid Medication Use | POD 7 | 0.38 pills consumed | Standard Deviation 0.885 |
| Treatment Group | Opioid Medication Use | POD 8 | 0.25 pills consumed | Standard Deviation 0.577 |
| Control Group | Opioid Medication Use | POD 6 | 0.30 pills consumed | Standard Deviation 0.79 |
| Control Group | Opioid Medication Use | POD 2 | 1.40 pills consumed | Standard Deviation 1.81 |
| Control Group | Opioid Medication Use | POD 1 | 1.87 pills consumed | Standard Deviation 1.92 |
| Control Group | Opioid Medication Use | POD 3 | 1.07 pills consumed | Standard Deviation 1.39 |
| Control Group | Opioid Medication Use | POD 4 | 1.00 pills consumed | Standard Deviation 1.36 |
| Control Group | Opioid Medication Use | POD 8 | 0.20 pills consumed | Standard Deviation 0.775 |
| Control Group | Opioid Medication Use | POD 9 | 0.27 pills consumed | Standard Deviation 1.03 |
| Control Group | Opioid Medication Use | POD 5 | 0.567 pills consumed | Standard Deviation 1.23 |
| Control Group | Opioid Medication Use | POD 10 | 0.27 pills consumed | Standard Deviation 0.8 |
| Control Group | Opioid Medication Use | POD 7 | 0.27 pills consumed | Standard Deviation 0.799 |
| Control Group | Opioid Medication Use | POD 0 | 1.07 pills consumed | Standard Deviation 1.22 |