Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified, Fracture Distal Radius, Fracture Elbow, Fracture Fixation, Fracture Fixation, Internal, Fracture Forearm
Conditions
Brief summary
This study is a prospective, randomized, double-blind clinical trial evaluating whether intraoperative intravenous lidocaine infusion (IVLI) reduces opioid requirements and improves postoperative pain control in children undergoing surgical fixation of upper extremity long bone fractures under general anesthesia. Ninety pediatric patients, ages 3-18 will be enrolled and randomized 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery. All participants will receive standardized anesthesia care and postoperative pain management. Opioid consumption and pain scores will be measured intraoperatively and throughout the postoperative recovery, with the primary outcome focused on total opioid use 60 minutes after arrival to the post-anesthesia care unit (PACU). Secondary outcomes include opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use and the relationship between infusion duration and outcomes. Patients will be closely monitored for signs of local anesthetic systemic toxicity and other adverse events. The goal of this study is to determine whether IV lidocaine is an effective opioid-sparing adjunct in pediatric orthopedic surgery and to support safer, multimodal analgesia strategies.
Interventions
DRUGLidocaine Infusion
Patients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups.
OTHERStandard of Care (SOC)
Standard of care
Sponsors
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 3-18 years * Patients \> 10 kg * Patients who present to Nemours Children's Hospital - Delaware Valley (NCH-DE) for surgical fixation of upper extremity fractures from distal humerus to distal radius
Exclusion criteria
* Children \< 3 years or \> 18 years * Patients with allergy to local anesthetics * Patients who are eligible for an receive a peripheral nerve block * Patients with multi-trauma or open fractures * Patients with previous history of seizure disorder * Patients with conduction abnormalities or cardiac arrhythmia requiring chronic treatment * Patients on strong CYP450 inhibitors (fluvoxamine, erythromycin, ciprofloxacin, rifampin, allopurinol, ketoconazole, itraconazole) * Patients with chronic kidney or liver dysfunction * Patients with planned use of continuous infusion pain medications (opioids, ketamine, alpha-2- agonists) * Patients with positive pregnancy test prior to surgery or nursing mothers * Patients who parents decline enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total perioperative opioid consumption | 60 minutes after patient arrival to post-anesthesia care unit (PACU) | Determine the effect of IVLI on intraoperative and postoperative opioid consumption in pediatric patients undergoing orthopedic surgery for long bone fractures of the upper extremity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | 30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria. | The maximum postoperative pain scores in patients who received IVLI will be equivalent or less than patients who received placebo in PACU at 30, 60, and 90 minutes and the time when patient meets Phase 1 PACU discharge criteria. |
| Rescue Anti-Emetic Use | Duration of Phase 1 PACU length of stay | Assess the effect of IVLI on rescue anti-emetic use and Phase 1 PACU length of stay. |
| Infusion and Surgical Length | 60 minutes after patient arrives in post-anesthesia care unit (PACU) | Evaluate if the infusion time of IVLI impacts post-operative opioid consumption and post- operative pain scores. Hypothesis: Patients who receive IVLI for \> 2 hours will have lower post- operative opioid requirements and post-operative pain scores than patients who receive the infusion for \< 2 hours. |
Countries
United States
Contacts
CONTACTAngela Snow, MD
CONTACTIsabela Santiago, BS
Outcome results
None listed