Intravenous Lidocaine Infusion in Lumbar Fusion Surgery
ConditionLumbar Fusion Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Scheduled for elective lumbar fusion surgery under general anesthesia
American Society of Anesthesiologists (ASA) physical status I-III
Ability to provide written informed consent
Disqualifiers
Refusal to participate in the study
ASA physical status ≥IV
Body mass index >35 kg/m²
Known allergy or hypersensitivity to lidocaine or study medications
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine
DrugContinuous 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.
Normal Saline
DrugAn 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Lidocaine InfusionExperimental treatment 1 intervention
Group B: Placebo (Normal Saline)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative postoperative opioid consumption within the first 24 hours after surgery
Cumulative opioid consumption during the first 24 postoperative hours will be evaluated. Rescue analgesia will be administered as intravenous tramadol (100 mg) when the Numerical Rating Scale (NRS) pain score is ≥4. The cumulative tramadol dose administered during this period will be recorded in milligrams (mg).
Time frame
0 to 24 hours after surgerySecondary outcomes
1
Intraoperative remifentanil consumption
Cumulative remifentanil consumption during surgery will be recorded in micrograms (µg).
Time frame
From induction of anesthesia to the end of surgery2
Postoperative pain intensity
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).
Time frame
At arrival in the post-anesthesia care unit and at 2, 4, 6, 12, and 24 hours after surgery3
Time to first rescue analgesic requirement
Time from the end of surgery to the first administration of rescue intravenous tramadol will be recorded.
Time frame
Within the first 24 hours after surgery4
Quality of recovery
Quality of recovery will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire, a validated patient-reported outcome measure assessing postoperative recovery. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
Time frame
Preoperative baseline and 24 hours after surgeryOther outcomes
1
Thiol-disulfide homeostasis parameters
Native thiol, total thiol, and disulfide levels will be measured to evaluate oxidative stress and thiol-disulfide homeostasis.
Time frame
Preoperatively and at 6 and 24 hours after surgery2
Length of hospital stay
Total duration of hospitalization will be recorded in days.
Time frame
Through hospital discharge, an average of 5 daysSponsors and contacts
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Source ClinicalTrials.gov