Lidocaine Infusion Reduces Opioid Requirements in Children - Phase 4 Trial NCT07552766
Summary
NIH registered a Phase 4 clinical trial (NCT07552766) on April 27, 2026 to evaluate whether intraoperative intravenous lidocaine infusion reduces total perioperative opioid requirements in 90 pediatric patients ages 3-18 undergoing surgical fixation of upper extremity long bone fractures. The prospective, randomized, double-blind trial enrolls participants 1:1 to receive either IV lidocaine or placebo (normal saline) during surgery under general anesthesia. The primary outcome measures total opioid consumption 60 minutes after arrival to the post-anesthesia care unit (PACU), with secondary outcomes including opioid use at additional time points, postoperative pain scores, PACU length of stay, rescue antiemetic use, and relationship between infusion duration and outcomes.
“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.”
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What changed
NIH registered a new Phase 4 clinical trial (NCT07552766) evaluating whether intraoperative intravenous lidocaine infusion reduces opioid requirements and improves postoperative pain control in pediatric patients undergoing upper extremity fracture fixation surgery. Ninety pediatric patients ages 3-18 will be randomized 1:1 to receive IV lidocaine or placebo during surgery, with standardized anesthesia and postoperative pain management for all participants. The primary outcome is total opioid consumption 60 minutes after PACU arrival; secondary outcomes include pain scores, PACU length of stay, rescue antiemetic use, and relationship between infusion duration and outcomes.
Affected parties include pediatric orthopedic surgery programs, anesthesiologists, and clinical researchers studying multimodal analgesia and opioid-sparing strategies in pediatric populations. While this is a study registration rather than a regulatory action, the findings could inform future clinical practice guidelines for pediatric multimodal analgesia if lidocaine demonstrates efficacy as an opioid-sparing adjunct.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Clinical Trial on the Use of Lidocaine Infusion During Surgery for Pediatric Upper Extremity Fractures and Its Impact on Total Perioperative Opioid Requirements
Phase 4 NCT07552766 Kind: PHASE4 Apr 27, 2026
Abstract
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.
Conditions: Fracture Arm, Fracture Closed of Lower End of Forearm, Unspecified, Fracture Elbow, Fracture Fixation, Fracture Fixation, Internal, Fracture Forearm, Fracture Distal Radius
Interventions: Lidocaine Infusion, Standard of Care (SOC)
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