Scarborough, Maine

Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures

An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Truama surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. The traditional narcotic intervention is: 60 pills of Norco 5-325 q4 hours PRN. Patients in the nonnarcotic and narocotic intervention will be given the following pre-operative pain protocol: Celebrex 400mg PO, Lyrica 75mg x1 dose pre-op, Tramadol 50mg x 1 Patients in the non-narcotic and narcotic intervention will be given the following intraoperative pain injection: Epinephrine 1mg (1mL), 0.5% ropivacaine (60mL), Acetaminophen 1000mg IV, Toradol 30mg (1ml) Postoperative day 1: Motrin - also known as ibuprofen 800 mg every 6 hours; not to exceed 3200 mg/day Lyrica - also known as pregabalin 75mg q12hr Tylenol - also known as acetaminophen 1000mg PO q8hr PRN pain Zanaflex - also know as tizanidine 4mg PO q6hr The Postoperative pain control will be as follows: Weeks 1 and 2: 1. Motrin - also known as Ibuprofen (for 2 weeks) 800 mg every 6 hours; not to exceed 3200 mg/day 2. Lyrica (also known as pregabalin) 75mg twice per day for 5 days then wean off as described below. Dispense: 30 tablets at discharge (75mg/tablet). Days 6-7: morning-75mg; evening- 75mg. Days 8-9: morning-75mg. Days 10: No more Lyrica 3. Tylenol (also known as acetaminophen) 1000 mg three times per day. Do not exceed a total of 4 grams of Acetaminophen per day. 4. Zanaflex (also known as tizanidine) 4 mg every 6-12 hours for 2 weeks. Weeks 2 - 4: 1. Tylenol (also known as acetaminophen) 1000 mg three times per day. Do Not exceed a total of 4 grams of Acetaminophen per day. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion

A Study of GSK5764227 in Participants With Advanced Solid Tumors

Optimizing Body Mass Index (BMI) With TCMCB07, The Paradox Trial

Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen. Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies

PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

A total of up to 100 participants will be enrolled in this research study, at up to 15 centers. Participants in the study will receive either PUL-042 or a placebo (an inactive agent that appears identical to PUL-042). Patients will be randomized 1:1 for PUL-042 or placebo. The first 50 patients will either be low dose PUL-042 or placebo. After review of the safety data from the initial patients, the PUL-042 dose may be increased. Subjects will be evaluated by chest x-ray and clinical status for respiratory complications.