Clinical trial NCT06484439: Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction
Official title: "A Prospective Randomized Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Post-operative
Third Molar
Oral Surgery
Pain, Acute
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2024-07-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 inclusion/exclusion 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 1:100k epinephrine will be given as a nerve block for the inferior alveolar nerve bilaterally. Then one cartridge of 0.5% bupivacaine with 1:200k 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 investigator's cell phone number if any adverse reactions present themselves.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years or older
* Scheduled for 3rd molar extraction (x4) with at least one mandibular 3rd molar impacted
* American Society of Anesthesiologists classification 1 or 2
* Able to provide consent, adhere to study schedule, complete study journal, and understand English

Exclusion Criteria:

* History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids
* Contraindication to lidocaine, epinephrine, bupivacaine, or hydrocodone
* Significant drug allergy history
* Currently pregnant or nursing at time of study or within 1 month of drug administration
* Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches.
* Use of any of the following medication within 1 month of EXPAREL infiltration or if the medications are being given to control pain: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Nonadrenaline Reuptake Inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine.
* Current use of systemic glucocorticosteroids within 1 month of enrollment in the study
* No concurrent surgical procedures within 2 weeks before or after 3rd molar extractions

Primary outcomes:
measure: Post operative pain control after third molar extraction
timeFrame: Up to five days post operative procedure.
measure: Post operative opioid use after third molar extraction
timeFrame: Up to five days post operative procedure.
measure: Post operative pain assessment after third molar extraction
timeFrame: Up to five days post operative procedure.
measure: Post operative quality of life assessment after third molar extraction
timeFrame: Up to five days after third molar extraction.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: Patrick T Morrell, DMD
role: PRINCIPAL_INVESTIGATOR
References: