Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction

NCT ID: NCT06484439

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2021-12-01

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.

Conditions

Pain, Post-operative; Third Molar; Oral Surgery; Pain, Acute

Study Design

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

Study Groups

Acetaminophen, Ibuprofen, Hydrocodone Control arm

The control arm will be 650 mg Acetaminophen PO scheduled q6h, 600mg Ibuprofen PO scheduled q6h and 5 mg Hydrocodone PO PRN q6h.

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

650 mg q 6h scheduled

Ibuprofen

Intervention Type: DRUG

600 mg PO scheduled q6h

Hydrocodone

Intervention Type: DRUG

5 mg hydrocodone PO PRN q6h

Ketorolac, Acetaminophen, Oxycodone Study arm

The study arm will be 10 mg Ketorolac PO q6h, 650 mg Acetaminophen PO scheduled q6h, and 5 mg Oxycodone PO PRN q6h.

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

10 mg PO q 6h scheduled

Oxycodone

Intervention Type: DRUG

5 mg PO PRN

Acetaminophen

Intervention Type: DRUG

650 mg q 6h scheduled

Interventions

Ketorolac

10 mg PO q 6h scheduled

Intervention Type: DRUG

Oxycodone

5 mg PO PRN

Intervention Type: DRUG

Acetaminophen

650 mg q 6h scheduled

Intervention Type: DRUG

Ibuprofen

600 mg PO scheduled q6h

Intervention Type: DRUG

Hydrocodone

5 mg hydrocodone PO PRN q6h

Intervention Type: DRUG

Other Intervention Names

Toradol; Oxycontin; Tylenol; Motrin; Vicodin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Patrick Morrell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick T Morrell, DMD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2018.0014

Identifier Type: -

Identifier Source: org_study_id