Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484439
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-06-04
Brief Title:
Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction
Sponsor:
United States Naval Medical Center San Diego
Organization:
United States Naval Medical Center San Diego
Study Overview
Official Title:
A Prospective Randomized Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction
Status:
COMPLETED
Status Verified Date:
2024-07
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:
This is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative pain and reduce opioid consumption
Detailed Description:
The recruitment of patients is covered in another section Once patients are recruited based on inclusionexclusion criteria they will be consented and randomized into one of the 2 arms The pre and perioperative anesthesia protocols will be identical for each arm and will consist of an opioid free general anesthesia Local anesthesia will be given in an identical fashion in all arms One cartridge of 2 lidocaine with 1100k epinephrine will be given as a nerve block for the inferior alveolar nerve bilaterally Then one cartridge of 05 bupivacaine with 1200k epinephrine will be locally injected for at each of the four 3rd molar sites Both arms will be injected with 133mg 10cc of liposomal bupivacaine The third molars will then be extracted in typical fashion Each patient will be attached to one of two postoperative arms distinguished by the post-operative medications received The control arm will be 650 mg Tylenol PO scheduled q6h 600mg Motrin per os PO scheduled q6h and 5 mg hydrocodone PO pro re nata PRN q6h The study arm will be 10 mg Toradol PO q6h 650 mg acetaminophen PO scheduled q6h and 5 mg oxycodone PO PRN q6h The blinded medication will be either the 600mg Motrin or the 10mg Toradol The patients will be standard 3rd molar extraction post-operative instructions as well as specific instructions on how to take medications The identity of the patients will be linked to a key that will be kept in a locked box inside a keypad entry office All future pain assessors will be blinded to the arm of the study in which the patient is attached The patients will respond to daily pain intensity scores medications taken quality of life measures through a survey The patients will be taught about the surveys during the consent process and again postoperatively An email or phone will be done for the patients on the following morning for the first 5 days postoperatively The patient will be instructed to complete the survey that will assess pain medications taken and quality of life items The patients will submit these daily until they return to clinic 5 days post-op where they will again submit one survey collectively discussing the outcomes of the previous 5 days All arms will have the primary investigators cell phone number if any adverse reactions present themselves
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?:
False
Is an FDA AA801 Violation?:
None