Postoperative PainPhase 3NCT06989866
RCT to Test Regional Anesthesia Effect on Decreased Opiate Use
A Phase 3 study testing Bupivacaine in people with Postoperative Pain, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
Examining use of strong pain medication with the use of perioperative anesthetic medications vs no use of the same perioperative medication Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients receiving a primary septorhinplasty at NMCP or Langley Air Force Base
Who cannot join
- History of alcohol abuse/dependence, mental health medications or opiate use disorder. Revision surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Official title: Opiate-sparing Post-operative Pain Control in Septorhinoplasty: A Prospective Randomized, Double Blind Clinical Trial
Examining use of strong pain medication with the use of perioperative anesthetic medications vs no use of the same perioperative medication
Read the detailed description
Control group:
- At the end of the Septorhinoplasty while the patient is still under general anesthesia, an associate investigator assisting in the case will administer normal saline to V2 (maxillary branch of the trigeminal nerve superiorly), nasal dorsum, and infraorbital foramen on each side. The total volume will consist of up to 10ml of normal saline. These injections are not standard of care but are performed for research purposes. The injections will be performed under the direct supervision of the staff surgeon, a board certified otolaryngologist. Each AI has performed injections of this nature (method and location) before - not with Exparel but the method and location are the same.
- Following surgery, the subject will receive handouts including patient informational sheet regarding appropriate use of opioid medications, scheduling acetaminophen and ibuprofen, and a tracking sheet or medication usage. The tracking sheet is provided for study purposes, whereas all other materials are per the standard of care.
- Oral medications will be prescribed by resident physician per the standard of care guidelines.
- Subjects will be counseled on return precautions and will be given contact information for routine and emergency visits (standard of care).
- Patients will be instructed to return in one week for removal of the intraoperative splint placement (standard of care) and bring the tracking sheets and medications with them (research purposes only).
Treatment group:
- At the end of the Septorhinoplasty while the patient is still under general anesthesia, an associate investigator assisting in the case will administer liposomal bupivacaine (Exparel) to V2 (maxillary branch of the trigeminal nerve superiorly), nasal dorsum, and infraorbital foramen on each side. The total volume will be the same as the control group: up to 10mL. These injections are not standard of care but are performed for research purposes. The injections will be performed under the direct supervision of the staff surgeon, a board-certified otolaryngologist. Each AI has performed injections of this nature (method and location) before - not with Exparel but the method and location are the same.
- Following surgery, the patient will receive handouts including patient informational sheet regarding appropriate use of opioid medications, scheduling acetaminophen and ibuprofen, and a tracking sheet for medication usage. The tracking sheet is provided for study purposes, whereas all other materials are per the standard of care.
- Medications will be prescribed by resident physician per the standard of care guidelines.
- Patients will be counseled on return precautions and will be given contact information for routine and emergency visits (standard of care).
- Patients will be informed to return in one week for removal of the intraoperative splint placement (standard of care) and bring the tracking sheets and pill bottles with them (research purposes only).
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:
- Patients will return for removal of their intranasal splints at approximately one week postop (standard of care).
- During this encounter medication tracking sheets (DCT 003) will be collected, and a validated pain survey (PROMIS - Patient-Reported Outcome Measurement Information System, DCT 002) will be administered in office for research purposes. The PROMIS questionnaire has been amended to only include the 3 questions needed for this study.
- Investigators will record the total pills remaining from opioid prescription for research purposes.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine, Saline (NaCl 0,9 %) (placebo)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Bupivicaine injection post operatively
Saline (NaCl 0,9 %) (placebo)Drug
Saline injected to control group
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Experimental | Application of regional block to the nose with Exparel Receives: Drug: Bupivacaine |
| Saline | Placebo comparator | Application of injectable saline to the nose Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Opiate Pain Medications After Rhinoplasty
How many opiate pills are used after rhinoplasty
Measured: 1 week
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Dec 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tokunbo I Ayeni, MD, Principal investigator, United States Naval Medical Center, Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989866
- Sponsor's protocol ID
- NMCP.2024.0031
- Status last verified
- Oct 2025
- First submitted
- 10 Apr 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opiate-sparing Post-operative Pain Control in Septorhinoplasty: A Prospective Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06989866
- Acronym / sponsor ID
- NMCP.2024.0031
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Examining use of strong pain medication with the use of perioperative anesthetic medications vs no use of the same perioperative medication
Detailed description
Control group:
- At the end of the Septorhinoplasty while the patient is still under general anesthesia, an associate investigator assisting in the case will administer normal saline to V2 (maxillary branch of the trigeminal nerve superiorly), nasal dorsum, and infraorbital foramen on each side. The total volume will consist of up to 10ml of normal saline. These injections are not standard of care but are performed for research purposes. The injections will be performed under the direct supervision of the staff surgeon, a board certified otolaryngologist. Each AI has performed injections of this nature (method and location) before - not with Exparel but the method and location are the same.
- Following surgery, the subject will receive handouts including patient informational sheet regarding appropriate use of opioid medications, scheduling acetaminophen and ibuprofen, and a tracking sheet or medication usage. The tracking sheet is provided for study purposes, whereas all other materials are per the standard of care.
- Oral medications will be prescribed by resident physician per the standard of care guidelines.
- Subjects will be counseled on return precautions and will be given contact information for routine and emergency visits (standard of care).
- Patients will be instructed to return in one week for removal of the intraoperative splint placement (standard of care) and bring the tracking sheets and medications with them (research purposes only).
Treatment group:
- At the end of the Septorhinoplasty while the patient is still under general anesthesia, an associate investigator assisting in the case will administer liposomal bupivacaine (Exparel) to V2 (maxillary branch of the trigeminal nerve superiorly), nasal dorsum, and infraorbital foramen on each side. The total volume will be the same as the control group: up to 10mL. These injections are not standard of care but are performed for research purposes. The injections will be performed under the direct supervision of the staff surgeon, a board-certified otolaryngologist. Each AI has performed injections of this nature (method and location) before - not with Exparel but the method and location are the same.
- Following surgery, the patient will receive handouts including patient informational sheet regarding appropriate use of opioid medications, scheduling acetaminophen and ibuprofen, and a tracking sheet for medication usage. The tracking sheet is provided for study purposes, whereas all other materials are per the standard of care.
- Medications will be prescribed by resident physician per the standard of care guidelines.
- Patients will be counseled on return precautions and will be given contact information for routine and emergency visits (standard of care).
- Patients will be informed to return in one week for removal of the intraoperative splint placement (standard of care) and bring the tracking sheets and pill bottles with them (research purposes only).
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:
- Patients will return for removal of their intranasal splints at approximately one week postop (standard of care).
- During this encounter medication tracking sheets (DCT 003) will be collected, and a validated pain survey (PROMIS - Patient-Reported Outcome Measurement Information System, DCT 002) will be administered in office for research purposes. The PROMIS questionnaire has been amended to only include the 3 questions needed for this study.
- Investigators will record the total pills remaining from opioid prescription for research purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel | Experimental | Drug: BupivacaineApplication of regional block to the nose with Exparel |
| Saline | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Application of injectable saline to the nose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving a primary septorhinplasty at NMCP or Langley Air Force Base
Key exclusion criteria (1 listed)
- History of alcohol abuse/dependence, mental health medications or opiate use disorder. Revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineBupivicaine injection post operatively | Drug | Exparel |
| Saline (NaCl 0,9 %) (placebo)Saline injected to control group | Drug | Saline |
Primary outcome
Use of Opiate Pain Medications After Rhinoplasty
Time frame: 1 week
How many opiate pills are used after rhinoplasty
1 secondary outcome
PROMIS - Pain Intensity Questionnaire
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tokunbo I Ayeni, MD principal investigator
United States Naval Medical Center, Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine in people with Postoperative Pain, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Opiate Pain Medications After Rhinoplasty (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.