RecruitingNot ApplicableNCT07488832

Intravenous Lidocaine Infusion in Lumbar Fusion Surgery

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


Sponsor

Ankara City Hospital Bilkent

Enrollment

110 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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

Exclusion Criteria10

  • Refusal to participate in the study
  • ASA physical status ≥III
  • Body mass index >35 kg/m²
  • Known allergy or hypersensitivity to lidocaine or study medications
  • Severe cardiac, hepatic, or renal disease
  • Pregnancy
  • Neurological disorders affecting pain assessment
  • Chronic opioid use
  • Use of opioids or antiemetic drugs before surgery
  • Inability to cooperate with postoperative assessments

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Interventions

DRUGLidocaine

Continuous intravenous lidocaine infusion will be administered during lumbar fusion surgery at a rate of 2 mg/kg/h following induction of general anesthesia. The infusion will be maintained throughout the surgical procedure and discontinued at the end of surgery.

DRUGNormal Saline

An intravenous infusion of normal saline (0.9% sodium chloride) will be administered at an equivalent rate during surgery following induction of general anesthesia. The infusion will be maintained throughout the surgical procedure and discontinued at the end of surgery.


Locations(1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

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NCT07488832