Efficacy of Liposomal Bupivacaine Post Septorhinoplasty

Pain Management Clinical Trial

Official title:

The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty: A Single-blinded, Prospective Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05964868
• Other study ID #: STUDY00020710
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: February 5, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine if there is a difference in post-operative pain after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia compared to other standard local anesthetic regimens.

Description:

Hypothesis: Patients receiving postoperative liposomal bupivacaine (EXPAREL®) at the surgical site after their septorhinoplasty will have better postoperative pain control and require fewer narcotics by means of a lower MME compared to the placebo group and the group that receives postoperative 0.25% bupivacaine with 1:200,000 epinephrine.

This a prospective randomized controlled, single-blind study evaluating the efficacy of EXPAREL® versus plain bupivacaine HCl and placebo after perinasal injections during septorhinoplasty procedures. Seventy-two total patients undergoing septorhinoplasty will be randomly distributed into three groups (20 patients per group) with various postoperative local anesthesia regimens. All groups will be given standard oral postoperative pain regimens as prescribed by the primary surgeon, typically consisting of alternating doses of 1000 mg acetaminophen and 800 mg ibuprofen with oxycodone 5 mg every 6 hours as needed for breakthrough pain. All three groups will receive the same treatment at the beginning of surgery with pre-incisional local surgical site injections with perinasal blocks of 1% lidocaine with 1:100,000 epinephrine. Group one (study group) will receive a five mL injection of EXPAREL® postoperatively, group two will receive a five mL injection of 0.25% bupivacaine with 1:200,000 epinephrine postoperatively, and group three will receive a five mL injection of saline along the surgical site, all in a ring block fashion (see illustration). This ring block involves nerve blocks to nasal branches of the supratrochlear, infraorbital, and infratrochlear nerves. This will also be injected into the floor of the nasal cavity to block branches of the nasopalatine nerve. The remainder of the ring block targets local infiltration surrounding the nose and injections are over bone. Although there is a potential risk of diffusion to adjacent cartilage, this risk is predicted to be low. Their use of postoperative pain medications will then be documented in the immediate postoperative period in the post-anesthesia care unit (PACU) as well as the following week postoperatively, every day, for three times a day. All groups will be required to fill electronic pain journals through RedCap (a HIPPA compliant server) to record consumption of pain medications and pain levels as reported by visual analog pain scales, the Wong-Baker FACES pain rating scale, and modified McGill pain questionnaire, all of which are validated tools for pain assessment. Patients will be subsequently followed over the course of six months postoperatively with these validated measures, use of pain medication, and by clinical exam of the nose/injection site including both external and internal nasal exam, palpation of the nose and cartilage grafts, evaluation static and dynamic function of the nose, and the presence of any adverse outcomes including but not limited to cartilage graft loss, septal perforation, synechiae formation, infection, and persistent or worsening nasal obstruction.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Subject must be undergoing rhinoplasty or septorhinoplasty surgery

2. Male or female subjects greater than or equal to 18 years of age

3. Written informed consent must be obtained

Exclusion Criteria:

2. The subject is a pregnant or lactating 3. Patients have a cognitive impairment 4. Patient is a prisoner 5. Patients with hypersensitivity to local anesthetics and pain medications used in the study 6. Patients weighing less than 48 kg 7. Patients preoperatively taking narcotics for chronic pain 8. Patients with pre-existing painful conditions (complex regional pain syndrome, fibromyalgia, neuropathy) 9. Patients with liver dysfunction 10. Patients with increased creatinine (over 1.5 mg/dl) 11. Patients who have undergone autologous costal cartilage grafting with their rhinoplasty 12. Morbid obesity (BMI >40)

Related Conditions & MeSH terms

• Pain Management
• Rhinoplasty

Intervention

Drug:
• Liposomal Bupivacaine
Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.
• 0.25% bupivacaine with 1:200,000 epinephrine
Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.

Other:
• Placebo - Saline solution
This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.

Locations

Country	Name	City	State
United States	Jessyka Lighthall	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Jessyka Lighthall

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in postoperative milligram morphine equivalents (MME) used between placebo and liposomal bupivacaine	Convert amount of opioid ingested to MMEs as an objective measure of post-operative narcotic use	6 months
Secondary	Different in patient reported outcome measure of subjective pain scores based on a validated visual analog pain scale (subjective measure) between placebo and test drug	Validated universal pain assessment tool: Wong-Baker pain scale pain questionnaire. Min 0 = no pain to 10 = maximum pain	6 months
Secondary	Difference in time to first dose of opioid rescue after surgery between placebo and test drug	measure the time from leaving surgery to when the first dose of opioid is taken	6 months
Secondary	Difference in breathing outcomes between placebo and test drug	NOSE questionnaire minimum 0 no obstruction to 100 complete obstruction	6 months
Secondary	Difference in adverse events/complications between placebo and test drug	Assess for general adverse events and post-operative complications	6 months