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NCT Number: NCT07488832

Intravenous Lidocaine Infusion in Lumbar Fusion Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gokhan Erdem, MD, PhD

CONTACT

[email protected]

05326258766

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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.

normal saline

Drug

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.

Primary outcomes

  1. Cumulative postoperative opioid consumption within the first 24 hours after surgery

    Time frame: 0 to 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).

Secondary outcomes

  1. Intraoperative remifentanil consumption

    Time frame: From induction of anesthesia to the end of surgery

    Cumulative remifentanil consumption during surgery will be recorded in micrograms (µg).

  2. Postoperative pain intensity

    Time frame: At arrival in the post-anesthesia care unit and at 2, 4, 6, 12, and 24 hours after surgery

    Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).

  3. Time to first rescue analgesic requirement

    Time frame: Within the first 24 hours after surgery

    Time from the end of surgery to the first administration of rescue intravenous tramadol will be recorded.

  4. Quality of recovery

    Time frame: Preoperative baseline and 24 hours after surgery

    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.

  5. Postoperative nausea and vomiting incidence

    Time frame: 0-24 hours after surgery

    The incidence of postoperative nausea and/or vomiting and the requirement for rescue antiemetic treatment will be recorded.

  6. Post-anesthesia care unit length of stay

    Time frame: Immediate postoperative period (up to 24 hours after surgery)

    Duration of stay in the post-anesthesia care unit will be recorded in minutes.

  7. Time to mobilization

    Time frame: Up to 24 hours after surgery

    Time from the end of surgery to the first mobilization will be recorded.

  8. Serum interleukin-6 (IL-6) levels

    Time frame: Preoperatively and at 6 and 24 hours after surgery

    Serum interleukin-6 (IL-6) levels will be measured to evaluate the inflammatory response.

Other outcomes

  1. Thiol-disulfide homeostasis parameters

    Time frame: Preoperatively and at 6 and 24 hours after surgery

    Native thiol, total thiol, and disulfide levels will be measured to evaluate oxidative stress and thiol-disulfide homeostasis.

  2. Length of hospital stay

    Time frame: Through hospital discharge, an average of 5 days

    Total duration of hospitalization will be recorded in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Ankara Bilkent City Hospital

CONTACT

[email protected]

+90 312 552 6000

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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