Lumbar Fusion SurgeryNCT07488832
Intravenous Lidocaine Infusion in Lumbar Fusion Surgery
A study testing Lidocaine and Normal Saline in people with Lumbar Fusion Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Fusion Surgery
- What is being tested?
- Lidocaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Severe cardiac, hepatic, or renal disease
- Pregnancy
Show all 10Show fewer
- Neurological disorders affecting pain assessment
- Chronic opioid use
- Use of opioids or antiemetic drugs before surgery
- Inability to cooperate with postoperative assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara
Gokhan Erdem, MD, PhD, 05326258766, drgokhanerdem@gmail.com
About this study
Official title: 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.
Read the 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 years or older with American Society of Anesthesiologists (ASA) physical status I-III 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.
- Conditions
- Lumbar Fusion Surgery
- Being tested
- Lidocaine, Normal Saline
- Keywords
- Lumbar fusion surgery, Intravenous lidocaine infusion, Postoperative pain, Opioid consumption, Postoperative recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
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 SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0 to 24 hours after surgery
Secondary outcomes (8)
Intraoperative remifentanil consumption
Cumulative remifentanil consumption during surgery will be recorded in micrograms (µg).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Preoperatively and at 6 and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Apr 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Fusion SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to receive either intraoperative intravenous lidocaine infusion or placebo (normal saline) during lumbar fusion surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gokhan Erdem, MD, PhD, Principal investigator, Department of Anesthesiology and Reanimation, Ankara Bilkent City Hospital, Ankara, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488832
- Sponsor's protocol ID
- LidocaineInfusion
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Intravenous Lidocaine Infusion on Postoperative Opioid Consumption and Recovery After Lumbar Fusion Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07488832
- Acronym / sponsor ID
- LidocaineInfusion
- Conditions
- Lumbar Fusion Surgery
- Keywords
- Lumbar fusion surgery, Intravenous lidocaine infusion, Postoperative pain, Opioid consumption, Postoperative recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 years or older with American Society of Anesthesiologists (ASA) physical status I-III 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to receive either intraoperative intravenous lidocaine infusion or placebo (normal saline) during lumbar fusion surgery.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Infusion | Experimental | Drug: LidocainePatients 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. |
| Placebo (Normal Saline) | Placebo comparator | Drug: Normal SalinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Severe cardiac, hepatic, or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineContinuous 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. | Drug | Lidocaine Infusion |
| Normal SalineAn 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. | Drug | Placebo (Normal Saline) |
Primary outcome
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).
8 secondary outcomes
Intraoperative remifentanil consumption
Time frame: From induction of anesthesia to the end of surgery
Postoperative pain intensity
Time frame: 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 frame: Within the first 24 hours after surgery
Quality of recovery
Time frame: Preoperative baseline and 24 hours after surgery
Postoperative nausea and vomiting incidence
Time frame: 0-24 hours after surgery
Post-anesthesia care unit length of stay
Time frame: Immediate postoperative period (up to 24 hours after surgery)
Time to mobilization
Time frame: Up to 24 hours after surgery
Serum interleukin-6 (IL-6) levels
Time frame: Preoperatively and at 6 and 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
Related trials for Lumbar Fusion Surgery
Not yet recruiting
Comparing Long-Acting Local Pain Relief Methods in PLIF Surgery
Posterior Lumbar Interbody Fusion (PLIF), Postoperative Analgesia After Disc Surgery
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
Recruiting
Application of Chain Management Based on the IMB Model in Patients With Kinesiophobia Following Lumbar Fusion Surgery
Information-motivation-behavior Skills Model
RecruitingObservational study
The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
Transforaminal Lumbar Interbody Fusion Surgery
Not yet recruitingPhase 3
ITM vs ITM+Clonidine for Lumbar Fusions
Lumbar Fusion Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gokhan Erdem, MD, PhD principal investigator
Department of Anesthesiology and Reanimation, Ankara Bilkent City Hospital, Ankara, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Normal Saline in people with Lumbar Fusion Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ankara Bilkent City Hospital (+90 312 552 6000, ankarasehir@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative postoperative opioid consumption within the first 24 hours after surgery (time frame: 0 to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.