A Phase 4 interventional study of Lidocaine Infusion and Standard of Care (SOC) in Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified and Fracture Elbow, sponsored by Nemours Children's Clinic. Recruiting at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Nemours Children's Clinic · Phase 4, Interventional, and Treatment
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.
44 studies on the registry are indexed under Elbow Fractures; 13 are open to participants now.
This study's planned enrollment of 90 is above the median of 52 across 29 interventional studies indexed under Elbow Fractures.
Browse Elbow Fractures studies →Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lidocaine Infusion
Other: Standard of Care (SOC)
Patients will be randomized to receive either lidocaine infusion or placebo intraoperatively. Perioperative opioid requirements will be compared between the two groups.
Standard of care
Total perioperative opioid consumption
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
Time frame: 60 minutes after patient arrival to post-anesthesia care unit (PACU)
Postoperative pain scores
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.
Time frame: 30, 60, 90 minutes and the time when patient meets Phase 1 PACU discharge criteria.
Rescue Anti-Emetic Use
Assess the effect of IVLI on rescue anti-emetic use and Phase 1 PACU length of stay.
Time frame: Duration of Phase 1 PACU length of stay
Infusion and Surgical Length
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.
Time frame: 60 minutes after patient arrives in post-anesthesia care unit (PACU)
Plan to share: Undecided
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