Spine SurgeryPhase 4NCT05103215
Lidocaine Infusion With ANI Monitoring in Spine Surgery.
A Phase 4 study testing Lidocaine HCl 2% and Normal saline in people with Spine Surgery, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Lidocaine HCl 2% and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Apr 2023to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Twenty to eighty-year-old
- ASA class I-III patients undergoing
- Elective lumbar spine surgery under general anesthesia
Who cannot join
- Unable to understand the Numerical Rating Scale (NRS)
- Severe mental disorder
- Poor liver function
- Pregnant or lactating women
- Morbidly obese
- History of epilepsy or allergy to any of the drugs used in this study
Show all 10Show fewer
- Current use of opioids
- Baseline heart rate <50 beats/min
- Arrhythmia history with cardiac rhythm device
- Body weight <40 kg and >80kg
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Zhi-Fu Wu
About this study
Official title: The Analgesic Effect of Intravenous Lidocaine Infusion in Combination of Analgesia Nociception Index Monitoring in Spine Surgery.
To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery (≥2 sessions).
Read the detailed description
The patients undergoing elective lumbar spine surgery (≥2 sessions) are randomly assigned and divided patients into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Patients in control group receive the same volume of saline injection. During the operation, the dose of anesthetic drugs (propofol, remifentanil and rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value, Entropy (or BIS) value at 40-60, and ANI at 50-70 in both groups. The pain score (numerical rating scale), cumulative amount of opioids used after the operation within 3 days, and the quality of recovery on the third day after the operation are recorded and analyzed.
- Conditions
- Spine Surgery
- Being tested
- Lidocaine HCl 2%, Normal saline
- Keywords
- Lidocaine, enhanced recovery after surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HCl 2%Drug
Also called Xylocaine Injection 2%
Intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation.
Normal salineDrug
Also called 0.9% Normal Saline (20mL)
Intravenous injection of 1.5 mg/kg normal saline at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine group | Experimental | Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg Lidocaine HCl 2% at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Receives: Drug: Lidocaine HCl 2% |
| control group | Placebo comparator | Patients in control group receive the same volume of saline injection. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative amount of opioids used
cumulative amount of opioids used after the operation
Measured: within 48 hours after operation
the quality of recovery after the operation
Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome
Measured: on the third day after the operation
pain score
numerical rating scale, NRS, 0-10, higher score means worse outcome
Measured: within 72 hours after operation
Secondary outcomes (4)
cumulative amount of opioids used
cumulative amount of opioids used after the operation
Measured: within 72 hours after operation
cumulative amount of propofol used
cumulative amount of propofol used
Measured: during operation
cumulative amount of remifentanil used
cumulative amount of remifentanil used
Measured: during operation
cumulative amount of rocuronium used
cumulative amount of rocuronium used
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start25 Apr 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi-Fu Wu, MD, Study chair, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung City, Taiwan (R.O.C.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103215
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210157
- Status last verified
- Mar 2024
- First submitted
- 21 Oct 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Intravenous Lidocaine Infusion in Combination of Analgesia Nociception Index Monitoring in Spine Surgery.
- ClinicalTrials.gov ID
- NCT05103215
- Acronym / sponsor ID
- KMUHIRB-F(I)-20210157
- Conditions
- Spine Surgery
- Keywords
- Lidocaine, enhanced recovery after surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 2 Nov 2021 (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.
To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery (≥2 sessions).
Detailed description
The patients undergoing elective lumbar spine surgery (≥2 sessions) are randomly assigned and divided patients into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Patients in control group receive the same volume of saline injection. During the operation, the dose of anesthetic drugs (propofol, remifentanil and rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value, Entropy (or BIS) value at 40-60, and ANI at 50-70 in both groups. The pain score (numerical rating scale), cumulative amount of opioids used after the operation within 3 days, and the quality of recovery on the third day after the operation are recorded and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine group | Experimental | Drug: Lidocaine HCl 2%Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg Lidocaine HCl 2% at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. |
| control group | Placebo comparator | Drug: Normal salinePatients in control group receive the same volume of saline injection. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Twenty to eighty-year-old
- ASA class I-III patients undergoing
- Elective lumbar spine surgery under general anesthesia
Key exclusion criteria (10 listed)
- Unable to understand the Numerical Rating Scale (NRS)
- Severe mental disorder
- Poor liver function
- Pregnant or lactating women
- Morbidly obese
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 |
|---|---|---|
| Lidocaine HCl 2%Also: Xylocaine Injection 2%Intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. | Drug | lidocaine group |
| Normal salineAlso: 0.9% Normal Saline (20mL)Intravenous injection of 1.5 mg/kg normal saline at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. | Drug | control group |
Primary outcome
cumulative amount of opioids used
Time frame: within 48 hours after operation
cumulative amount of opioids used after the operation
the quality of recovery after the operation
Time frame: on the third day after the operation
Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome
pain score
Time frame: within 72 hours after operation
numerical rating scale, NRS, 0-10, higher score means worse outcome
4 secondary outcomes
cumulative amount of opioids used
Time frame: within 72 hours after operation
cumulative amount of propofol used
Time frame: during operation
cumulative amount of remifentanil used
Time frame: during operation
cumulative amount of rocuronium used
Time frame: during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Spine Surgery
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
Cervical Spine Fractures
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. This study is not recruiting at the moment.
Zhi-Fu Wu, MD study chair
Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung City, Taiwan (R.O.C.)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine HCl 2% and Normal saline in people with Spine Surgery, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Fu Wu, MD (07-3121101 ext. 7035, aneswu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative amount of opioids used (time frame: within 48 hours after operation). The study lists 3 primary outcomes in all. 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 21 Mar 2024.