RCT to Test Regional Anesthesia Effect on Decreased Opiate Use

NCT ID: NCT06989866

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-09-01

Brief Summary

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:

1. 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.

2. 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.

3. Oral medications will be prescribed by resident physician per the standard of care guidelines.

4. Subjects will be counseled on return precautions and will be given contact information for routine and emergency visits (standard of care).

5. 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:

1. 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.

2. 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.

3. Medications will be prescribed by resident physician per the standard of care guidelines.

4. Patients will be counseled on return precautions and will be given contact information for routine and emergency visits (standard of care).

5. 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:

1. Patients will return for removal of their intranasal splints at approximately one week postop (standard of care).

2. 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.

3. Investigators will record the total pills remaining from opioid prescription for research purposes.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exparel

Application of regional block to the nose with Exparel

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

Bupivicaine injection post operatively

Saline

Application of injectable saline to the nose

Group Type: PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type: DRUG

Saline injected to control group

Interventions

Bupivacaine

Bupivicaine injection post operatively

Intervention Type: DRUG

Saline (NaCl 0,9 %) (placebo)

Saline injected to control group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients receiving a primary septorhinplasty at NMCP or Langley Air Force Base

Exclusion Criteria

• History of alcohol abuse/dependence, mental health medications or opiate use disorder. Revision surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, Portsmouth

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tokunbo I Ayeni, MD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, Portsmouth

Locations

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

NMCP.2024.0031

Identifier Type: -

Identifier Source: org_study_id