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Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery

The Role of Regional Anesthesia to Reduce Opioid Requirements Following Functional Endoscopic Sinus Surgery (FESS)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03757715
Enrollment
46
Registered
2018-11-29
Start date
2019-05-20
Completion date
2021-04-12
Last updated
2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management

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

DRUGBupivacaine

20 mL of 1.3% bupivacaine

DRUGDexamethasone

2 mg dexamethasone

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Participant Pain Control10 daysSelf-report of pain score on a scale of 0 to 10, with 0 being no pain and 10 being worst pain imaginable

Secondary

MeasureTime frameDescription
Opioid Medication Use10 daysAmount 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

ArmCount
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
Total31

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up49
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicControl GroupTreatment GroupTotal
Age, Continuous36.73 years
STANDARD_DEVIATION 13.1
48.69 years
STANDARD_DEVIATION 17.79
42.90 years
STANDARD_DEVIATION 13.59
Anxiety/Depression
No
14 Participants11 Participants25 Participants
Anxiety/Depression
Yes
1 Participants5 Participants6 Participants
Body Mass Index31.71 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 Participants15 Participants27 Participants
Diabetes
Yes
3 Participants1 Participants4 Participants
Migraine
No
12 Participants15 Participants27 Participants
Migraine
Yes
3 Participants1 Participants4 Participants
Obstructive Sleep Apnea
No
12 Participants14 Participants26 Participants
Obstructive Sleep Apnea
Yes
3 Participants2 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
5 Participants2 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants13 Participants23 Participants
Region of Enrollment
United States
15 participants16 participants31 participants
Sex: Female, Male
Female
6 Participants9 Participants15 Participants
Sex: Female, Male
Male
9 Participants7 Participants16 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 15
other
Total, other adverse events
0 / 160 / 15
serious
Total, serious adverse events
0 / 160 / 15

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
Treatment GroupParticipant Pain ControlPOD 24.06 units on a scaleStandard Deviation 1.84
Treatment GroupParticipant Pain ControlPOD 63.00 units on a scaleStandard Deviation 2.58
Treatment GroupParticipant Pain ControlPOD14.63 units on a scaleStandard Deviation 1.86
Treatment GroupParticipant Pain ControlPOD 72.56 units on a scaleStandard Deviation 2.45
Treatment GroupParticipant Pain ControlPOD 43.38 units on a scaleStandard Deviation 1.93
Treatment GroupParticipant Pain ControlPOD 82.13 units on a scaleStandard Deviation 2.45
Treatment GroupParticipant Pain ControlPOD 04.5 units on a scaleStandard Deviation 2.83
Treatment GroupParticipant Pain ControlPOD 92.19 units on a scaleStandard Deviation 2.34
Treatment GroupParticipant Pain ControlPOD 53.00 units on a scaleStandard Deviation 2.42
Treatment GroupParticipant Pain ControlPOD 102.13 units on a scaleStandard Deviation 2.5
Treatment GroupParticipant Pain ControlPOD 34.13 units on a scaleStandard Deviation 1.46
Control GroupParticipant Pain ControlPOD 101.27 units on a scaleStandard Deviation 2.21
Control GroupParticipant Pain ControlPOD 33.20 units on a scaleStandard Deviation 2.01
Control GroupParticipant Pain ControlPOD 05.87 units on a scaleStandard Deviation 2.85
Control GroupParticipant Pain ControlPOD15.00 units on a scaleStandard Deviation 1.96
Control GroupParticipant Pain ControlPOD 24.13 units on a scaleStandard Deviation 1.89
Control GroupParticipant Pain ControlPOD 42.67 units on a scaleStandard Deviation 2.02
Control GroupParticipant Pain ControlPOD 52.33 units on a scaleStandard Deviation 1.76
Control GroupParticipant Pain ControlPOD 62.2 units on a scaleStandard Deviation 1.7
Control GroupParticipant Pain ControlPOD 72.13 units on a scaleStandard Deviation 1.6
Control GroupParticipant Pain ControlPOD 81.67 units on a scaleStandard Deviation 1.76
Control GroupParticipant Pain ControlPOD 91.73 units on a scaleStandard Deviation 2.22
p-value: 0.16t-test, 1 sided
Secondary

Opioid Medication Use

Amount of opioid medication used, based on pill count

Time frame: 10 days

ArmMeasureGroupValue (MEAN)Dispersion
Treatment GroupOpioid Medication UsePOD 21.69 pills consumedStandard Deviation 1.66
Treatment GroupOpioid Medication UsePOD 31.63 pills consumedStandard Deviation 1.45
Treatment GroupOpioid Medication UsePOD 40.97 pills consumedStandard Deviation 1.49
Treatment GroupOpioid Medication UsePOD 90.31 pills consumedStandard Deviation 0.6
Treatment GroupOpioid Medication UsePOD 100.31 pills consumedStandard Deviation 0.6
Treatment GroupOpioid Medication UsePOD 01.38 pills consumedStandard Deviation 1.03
Treatment GroupOpioid Medication UsePOD 12.31 pills consumedStandard Deviation 1.4
Treatment GroupOpioid Medication UsePOD 50.594 pills consumedStandard Deviation 1.11
Treatment GroupOpioid Medication UsePOD 60.50 pills consumedStandard Deviation 1.09
Treatment GroupOpioid Medication UsePOD 70.38 pills consumedStandard Deviation 0.885
Treatment GroupOpioid Medication UsePOD 80.25 pills consumedStandard Deviation 0.577
Control GroupOpioid Medication UsePOD 60.30 pills consumedStandard Deviation 0.79
Control GroupOpioid Medication UsePOD 21.40 pills consumedStandard Deviation 1.81
Control GroupOpioid Medication UsePOD 11.87 pills consumedStandard Deviation 1.92
Control GroupOpioid Medication UsePOD 31.07 pills consumedStandard Deviation 1.39
Control GroupOpioid Medication UsePOD 41.00 pills consumedStandard Deviation 1.36
Control GroupOpioid Medication UsePOD 80.20 pills consumedStandard Deviation 0.775
Control GroupOpioid Medication UsePOD 90.27 pills consumedStandard Deviation 1.03
Control GroupOpioid Medication UsePOD 50.567 pills consumedStandard Deviation 1.23
Control GroupOpioid Medication UsePOD 100.27 pills consumedStandard Deviation 0.8
Control GroupOpioid Medication UsePOD 70.27 pills consumedStandard Deviation 0.799
Control GroupOpioid Medication UsePOD 01.07 pills consumedStandard Deviation 1.22
p-value: 0.42t-test, 1 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026