Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:12 AM
Study NCT ID:
NCT07488832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Lidocaine Infusion in Lumbar Fusion Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to receive either intraoperative intravenous lidocaine infusion or placebo (normal saline) during lumbar fusion surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Thiol-disulfide homeostasis parameters', 'timeFrame': 'Preoperatively and at 6 and 24 hours after surgery', 'description': 'Native thiol, total thiol, and disulfide levels will be measured to evaluate oxidative stress and thiol-disulfide homeostasis.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Through hospital discharge, an average of 5 days', 'description': 'Total duration of hospitalization will be recorded in days.'}], 'primaryOutcomes': [{'measure': 'Cumulative postoperative opioid consumption within the first 24 hours after surgery', 'timeFrame': '0 to 24 hours after surgery', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Intraoperative remifentanil consumption', 'timeFrame': 'From induction of anesthesia to the end of surgery', 'description': 'Cumulative remifentanil consumption during surgery will be recorded in micrograms (µg).'}, {'measure': 'Postoperative pain intensity', 'timeFrame': 'At arrival in the post-anesthesia care unit and at 2, 4, 6, 12, and 24 hours after surgery', 'description': 'Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain).'}, {'measure': 'Time to first rescue analgesic requirement', 'timeFrame': 'Within the first 24 hours after surgery', 'description': 'Time from the end of surgery to the first administration of rescue intravenous tramadol will be recorded.'}, {'measure': 'Quality of recovery', 'timeFrame': 'Preoperative baseline and 24 hours after surgery', 'description': '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.'}, {'measure': 'Postoperative nausea and vomiting incidence', 'timeFrame': '0-24 hours after surgery', 'description': 'The incidence of postoperative nausea and/or vomiting and the requirement for rescue antiemetic treatment will be recorded.'}, {'measure': 'Post-anesthesia care unit length of stay', 'timeFrame': 'Immediate postoperative period (up to 24 hours after surgery)', 'description': 'Duration of stay in the post-anesthesia care unit will be recorded in minutes.'}, {'measure': 'Time to mobilization', 'timeFrame': 'Up to 24 hours after surgery', 'description': 'Time from the end of surgery to the first mobilization will be recorded.'}, {'measure': 'Serum interleukin-6 (IL-6) levels', 'timeFrame': 'Preoperatively and at 6 and 24 hours after surgery', 'description': 'Serum interleukin-6 (IL-6) levels will be measured to evaluate the inflammatory response.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar fusion surgery', 'Intravenous lidocaine infusion', 'Postoperative pain', 'Opioid consumption', 'Postoperative recovery'], 'conditions': ['Lumbar Fusion Surgery']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.', 'detailedDescription': '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.\n\nIntravenous 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.\n\nThis 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.\n\nAll 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.\n\nThe 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Scheduled for elective lumbar fusion surgery under general anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* ASA physical status ≥III\n* Body mass index \\>35 kg/m²\n* Known allergy or hypersensitivity to lidocaine or study medications\n* Severe cardiac, hepatic, or renal disease\n* Pregnancy\n* Neurological disorders affecting pain assessment\n* Chronic opioid use\n* Use of opioids or antiemetic drugs before surgery\n* Inability to cooperate with postoperative assessments'}, 'identificationModule': {'nctId': 'NCT07488832', 'briefTitle': 'Intravenous Lidocaine Infusion in Lumbar Fusion Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Opioid Consumption and Recovery After Lumbar Fusion Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LidocaineInfusion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine Infusion', 'description': '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.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Normal Saline)', 'description': '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.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Lidocaine Infusion']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo (Normal Saline)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gokhan Erdem, MD, PhD', 'role': 'CONTACT', 'email': 'drgokhanerdem@gmail.com', 'phone': '05326258766'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ankara Bilkent City Hospital', 'role': 'CONTACT', 'email': 'ankarasehir@saglik.gov.tr', 'phone': '+90 312 552 6000'}], 'overallOfficials': [{'name': 'Gokhan Erdem, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Reanimation, Ankara Bilkent City Hospital, Ankara, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}