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

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Fusion Surgery
• Intervention / Treatment: Drug: Lidocaine; Drug: Normal Saline

Detailed Description

Lumbar fusion surgery is frequently associated with significant postoperative pain and often requires high doses of opioid analgesics during the perioperative period. Opioid administration may lead to several adverse effects including postoperative nausea and vomiting, sedation, respiratory depression, and delayed recovery. Therefore, multimodal analgesia strategies are increasingly used to improve postoperative pain control and reduce opioid requirements.

Intravenous lidocaine infusion has gained attention as an adjunct component of multimodal analgesia because of its analgesic, antihyperalgesic, and anti-inflammatory properties. Previous clinical studies have suggested that perioperative systemic lidocaine may reduce postoperative pain intensity, decrease opioid consumption, and improve recovery after surgery. However, evidence regarding its effectiveness in patients undergoing lumbar fusion surgery remains limited.

This prospective, randomized, placebo-controlled study will include adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective lumbar fusion surgery. Participants will be randomly allocated into two groups. Patients in the lidocaine group will receive an intravenous lidocaine bolus followed by continuous lidocaine infusion during surgery, whereas patients in the control group will receive an equivalent volume of normal saline infusion. The infusion will be maintained throughout the surgical procedure and discontinued at the end of surgery.

All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain will be assessed using the Numerical Rating Scale (NRS). Rescue analgesia will be administered when clinically indicated.

The primary outcome is cumulative postoperative opioid consumption within the first 24 hours after surgery. Secondary outcomes include intraoperative opioid consumption, postoperative pain scores at predefined time points, time to first rescue analgesic requirement, postoperative nausea and vomiting incidence, quality of recovery measured by QoR-15, post-anesthesia care unit length of stay, time to mobilization, and hospital length of stay.

In addition, inflammatory and oxidative stress responses associated with surgery and lidocaine administration will be evaluated. Blood samples will be collected preoperatively and at 6 and 24 hours postoperatively to measure interleukin-6 (IL-6) levels and markers of thiol-disulfide homeostasis.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ankara Bilkent City Hospital; Phone Number: +90 312 552 6000; Email: ankarasehir@saglik.gov.tr

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • Ankara Bilkent City Hospital
    • Contact: Gokhan Erdem, MD, PhD; Phone Number: 05326258766; Email: drgokhanerdem@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Lidocaine; 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.
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.	Drug: Normal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0 to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative remifentanil consumption	Cumulative remifentanil consumption during surgery will be recorded in micrograms (µg).	From induction of anesthesia to the end of surgery
Postoperative pain intensity	Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).	At arrival in the post-anesthesia care unit and at 2, 4, 6, 12, and 24 hours after surgery
Time to first rescue analgesic requirement	Time from the end of surgery to the first administration of rescue intravenous tramadol will be recorded.	Within the first 24 hours after surgery
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.	Preoperative baseline and 24 hours after surgery
Postoperative nausea and vomiting incidence	The incidence of postoperative nausea and/or vomiting and the requirement for rescue antiemetic treatment will be recorded.	0-24 hours after surgery
Post-anesthesia care unit length of stay	Duration of stay in the post-anesthesia care unit will be recorded in minutes.	Immediate postoperative period (up to 24 hours after surgery)
Time to mobilization	Time from the end of surgery to the first mobilization will be recorded.	Up to 24 hours after surgery
Serum interleukin-6 (IL-6) levels	Serum interleukin-6 (IL-6) levels will be measured to evaluate the inflammatory response.	Preoperatively and at 6 and 24 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thiol-disulfide homeostasis parameters	Native thiol, total thiol, and disulfide levels will be measured to evaluate oxidative stress and thiol-disulfide homeostasis.	Preoperatively and at 6 and 24 hours after surgery
Length of hospital stay	Total duration of hospitalization will be recorded in days.	Through hospital discharge, an average of 5 days

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Gokhan Erdem, MD, PhD, Department of Anesthesiology and Reanimation, Ankara Bilkent City Hospital, Ankara, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative pain; Opioid consumption; Lumbar fusion surgery; Postoperative recovery; Intravenous lidocaine infusion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Crystalloid Solutions; Isotonic Solutions; Solutions; Lidocaine; Saline Solution
• Other Study ID Numbers: LidocaineInfusion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No