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Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Opioid Consumption and Recovery After Lumbar Fusion Surgery: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Elective lumbar fusion surgery is associated with moderate to severe postoperative pain and often requires substantial perioperative opioid administration. Excessive opioid use may lead to adverse effects such as nausea, vomiting, sedation, respiratory depression, and delayed mobilization. Intravenous lidocaine infusion has been proposed as part of multimodal analgesia because of its analgesic, antihyperalgesic, and anti-inflammatory properties. This randomized, placebo-controlled clinical trial aims to evaluate the effect of intraoperative intravenous lidocaine infusion on postoperative opioid consumption and early recovery outcomes in patients undergoing elective lumbar fusion surgery. Patients will be randomly assigned to receive either intravenous lidocaine infusion or placebo during surgery. The primary outcome is cumulative postoperative opioid consumption within the first 24 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative pain scores, time to first rescue analgesic, quality of recovery, postoperative nausea and vomiting, time to mobilization, and length of hospital stay. In addition, inflammatory and oxidative stress biomarkers including interleukin-6 (IL-6) and markers of thiol-disulfide homeostasis will be measured preoperatively and postoperatively.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Age between 18 and 65 years

• Scheduled for elective lumbar fusion surgery under general anesthesia

• American Society of Anesthesiologists (ASA) physical status I-II

• Ability to provide written informed consent

Locations
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Ankara Bilkent City Hospital
ankarasehir@saglik.gov.tr
+90 312 552 6000
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 110
Treatments
Experimental: Lidocaine Infusion
Patients in this group will receive continuous intravenous lidocaine infusion at a rate of 2 mg/kg/h throughout the surgical procedure following induction of general anesthesia. The infusion will be discontinued at the end of surgery. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.
Placebo_comparator: Placebo (Normal Saline)
Patients in this group will receive an intravenous infusion of normal saline at an equivalent rate throughout the surgical procedure following induction of general anesthesia. The infusion will be discontinued at the end of surgery. All patients will receive standardized general anesthesia and postoperative multimodal analgesia.
Related Therapeutic Areas
Sponsors
Leads: Ankara City Hospital Bilkent

This content was sourced from clinicaltrials.gov

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