Intravenous Lidocaine Infusion in Lumbar Fusion Surgery

NCT07488832 | Recruiting

• 1 other identifier: LidocaineInfusion
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Fusion Surgery

Keywords

Lumbar fusion surgery; Intravenous lidocaine infusion; Postoperative pain; Opioid consumption; Postoperative recovery

Outcome Measures

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).

  0 to 24 hours after surgery

Secondary Outcomes (8)

• Intraoperative remifentanil consumption

  From induction of anesthesia to the end of surgery

• Postoperative pain intensity

  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

  Within the first 24 hours after surgery

• Quality of recovery

  Preoperative baseline and 24 hours after surgery

• Postoperative nausea and vomiting incidence

  0-24 hours after surgery

Other Outcomes (2)

• Thiol-disulfide homeostasis parameters

  Preoperatively and at 6 and 24 hours after surgery

• Length of hospital stay

  Through hospital discharge, an average of 5 days

Study Arms (2)

Lidocaine Infusion

EXPERIMENTAL

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

Placebo (Normal Saline)

PLACEBO COMPARATOR

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

Interventions

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.

Lidocaine Infusion

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.

Placebo (Normal Saline)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gokhan Erdem, MD, PhD

  Department of Anesthesiology and Reanimation, Ankara Bilkent City Hospital, Ankara, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankara Bilkent City Hospital

CONTACT

+90 312 552 6000; ankarasehir@saglik.gov.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Lidocaine and placebo infusions will be prepared in identical syringes by an independent anesthesiologist not involved in patient care or outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to receive either intraoperative intravenous lidocaine infusion or placebo (normal saline) during lumbar fusion surgery.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)