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Examining use of strong pain medication with the use of perioperative anesthetic medications vs no use of the same perioperative medication
Control group:
Treatment group:
Both Control and Treatment groups:
Per NMCP policy, a teal-colored wrist band will be placed on all study participants following surgery indicating that Exparel was administered, even for those that did not receive Exparel. Subjects will be instructed not to remove the band for at least 96 hours (4 days) following surgery. All participants receive this band to maintain the blinding of the study. Local anesthetics, even topical (applied to the skin), should generally be avoided within 96 hours (4 days) of surgery. Should the subject seek emergency care at an outside facility in the 7 days following surgery, they will be instructed to inform providers that they are participating in a research study and may have received Exparel. If the provider has any questions or concerns, the subject will provide them with the ENT Duty contact information. The need for emergency care for post-septorhinoplasty patients is rare, and in most cases they will return to NMCP, but in the event they do not instructions will be provided to contact the NMCP ENT team. If the provider on duty is not an investigator on the study, they will contact a member of the study team to determine if the subject in question is part of the treatment or control group to help determine their care at the outside facility.
Follow-up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | Application of regional block to the nose with Exparel |
|
| Saline | Placebo Comparator | Application of injectable saline to the nose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivicaine injection post operatively |
| |
| Saline (NaCl 0,9 %) (placebo) |
| Measure | Description | Time Frame |
|---|---|---|
| Use of Opiate Pain Medications After Rhinoplasty | How many opiate pills are used after rhinoplasty | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS - Pain Intensity Questionnaire | Recording pain scale after surgery for 1 week, A score of 1 equals no pain/good outcome, score of 5 equals severe pain/worse outcome | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tokunbo I Ayeni, MD | United States Naval Medical Center, Portsmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
Saline injected to control group |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |