Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964868
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-13
First Post:
2023-07-06
Brief Title:
Efficacy of Liposomal Bupivacaine Post Septorhinoplasty
Sponsor:
Jessyka Lighthall
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty A Single-blinded Prospective Clinical Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 025 bupivacaine with 1200000 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 1100000 epinephrine Group one study group will receive a five mL injection of EXPAREL postoperatively group two will receive a five mL injection of 025 bupivacaine with 1200000 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 noseinjection 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
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 1100000 epinephrine Group one study group will receive a five mL injection of EXPAREL postoperatively group two will receive a five mL injection of 025 bupivacaine with 1200000 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 noseinjection 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None