Spine FusionNCT04711668
Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery
A study testing Ketamine, Lidocain and Saline in people with Spine Fusion and Postoperative Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery. Materials and Methods: Ethics committee approval was received from our faculty. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spine Fusion, Postoperative Pain
- What is being tested?
- Ketamine, Lidocain and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2019to 30 Dec 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III
Who cannot join
- Previous spinal surgery, Morbid obesity (BMI> 35 kg / m2), Lidocaine, ketamine or opioid allergy. Severe cardiac or pulmonary disease, Liver or kidney dysfunction Poorly controlled hypertension, Substance abuse, Chronic opioid use, Pregnancy, Psychiatric disorder, Cognitive impairment History of stroke, head injury, and intracranial mass or bleeding and patients who did not want to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery - Double-Blind Randomized Controlled Study
Objective: The primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery.
Materials and Methods: Ethics committee approval was received from our faculty. Seventy-five cases between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III in the preanesthetic evaluation, planned to be operated by the Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved.
Read more
The patients were randomly divided into 3 groups using the closed envelope method. The ketamine group (Group K) (n = 25), the lidocaine group (Group L) (n = 25) and the placebo group (Group P) (n = 25). Propofol, rocuronium and fentanyl i.v. done. In group K, 0.5 mg / kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. In group L, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was administered. In group P, i.v. saline (in the same volume and duration) was applied. Maintenance of anesthesia was provided by propofol and remifentanil infusion. The propofol and remifentanil doses were adjusted according to the BIS monitoring and the increase or decrease in basal blood pressure and heart rate values of 20% or more. The BIS value was kept between 40-60. At the end of surgery, infusions were closed. After extubation, the patients were taken to the recovery room. Patient controlled analgesia (PCA) prepared with fentanyl was applied to the patients for postoperative analgesia. The PCA device was attached for 24 hours postoperatively.
Postoperative 0-4 hours, 4-8 hours, 8-24 hours and total fentanyl consumption of the patients were evaluated. Pain scores were measured at 1, 2, 4, 8, 12 and 24 hours in the postoperative recovery room. Intraoperative propofol and remifentanil consumption was recorded. Tramadol 1 mg / kg i.v. as rescue analgesia (in patients with VAS pain score of 4 and above) done. Possible side effects due to opioid, ketamine and lidocaine were followed.
- Conditions
- Spine Fusion, Postoperative Pain
- Being tested
- Ketamine, Lidocain, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
intraoperative ketamine bolus and infusion
LidocainDrug
intraoperative lidocain bolus and infusion
SalineDrug
intraoperative saline bolus and infusion
| Study group | Role | What they receive |
|---|---|---|
| Group Ketamin | Experimental | 0.5 mg / kg i.v. ketamine bolus at induction and 0.25 mg / kg / hr i.v. ketamine infusion intraoperatively Receives: Drug: Ketamine |
| Group Lidokain | Experimental | 1.5 mg / kg i.v. lidocaine bolus at induction and 1.5 mg / kg / hr i.v. lidocaine infusion intraoperatively Receives: Drug: Lidocain |
| Group Placebo | Placebo comparator | i.v. saline (in the same volume and duration like group ketamine/lidokain) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
postoperative PCA wit fentanyl
Measured: postoperative 0-24 hours
Secondary outcomes (1)
postoperative pain score
pain score is visual analogue scala
Measured: postoperative 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start29 May 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedat Öztürk, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711668
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/308
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery - Double-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04711668
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/308
- Conditions
- Spine Fusion, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 15 Jan 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.
Objective: The primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery.
Materials and Methods: Ethics committee approval was received from our faculty. Seventy-five cases between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III in the preanesthetic evaluation, planned to be operated by the Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved.
The patients were randomly divided into 3 groups using the closed envelope method. The ketamine group (Group K) (n = 25), the lidocaine group (Group L) (n = 25) and the placebo group (Group P) (n = 25). Propofol, rocuronium and fentanyl i.v. done. In group K, 0.5 mg / kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. In group L, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was administered. In group P, i.v. saline (in the same volume and duration) was applied. Maintenance of anesthesia was provided by propofol and remifentanil infusion. The propofol and remifentanil doses were adjusted according to the BIS monitoring and the increase or decrease in basal blood pressure and heart rate values of 20% or more. The BIS value was kept between 40-60. At the end of surgery, infusions were closed. After extubation, the patients were taken to the recovery room. Patient controlled analgesia (PCA) prepared with fentanyl was applied to the patients for postoperative analgesia. The PCA device was attached for 24 hours postoperatively.
Postoperative 0-4 hours, 4-8 hours, 8-24 hours and total fentanyl consumption of the patients were evaluated. Pain scores were measured at 1, 2, 4, 8, 12 and 24 hours in the postoperative recovery room. Intraoperative propofol and remifentanil consumption was recorded. Tramadol 1 mg / kg i.v. as rescue analgesia (in patients with VAS pain score of 4 and above) done. Possible side effects due to opioid, ketamine and lidocaine were followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Ketamin | Experimental | Drug: Ketamine0.5 mg / kg i.v. ketamine bolus at induction and 0.25 mg / kg / hr i.v. ketamine infusion intraoperatively |
| Group Lidokain | Experimental | Drug: Lidocain1.5 mg / kg i.v. lidocaine bolus at induction and 1.5 mg / kg / hr i.v. lidocaine infusion intraoperatively |
| Group Placebo | Placebo comparator | Drug: Salinei.v. saline (in the same volume and duration like group ketamine/lidokain) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III
Key exclusion criteria (1 listed)
- Previous spinal surgery, Morbid obesity (BMI> 35 kg / m2), Lidocaine, ketamine or opioid allergy. Severe cardiac or pulmonary disease, Liver or kidney dysfunction Poorly controlled hypertension, Substance abuse, Chronic opioid use, Pregnancy, Psychiatric disorder, Cognitive impairment History of stroke, head injury, and intracranial mass or bleeding and patients who did not want to participate in the study were excluded from the study.
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 |
|---|---|---|
| Ketamineintraoperative ketamine bolus and infusion | Drug | Group Ketamin |
| Lidocainintraoperative lidocain bolus and infusion | Drug | Group Lidokain |
| Salineintraoperative saline bolus and infusion | Drug | Group Placebo |
Primary outcome
postoperative opioid consumption
Time frame: postoperative 0-24 hours
postoperative PCA wit fentanyl
1 secondary outcome
postoperative pain score
Time frame: postoperative 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Lidocain and Saline in people with Spine Fusion and Postoperative Pain, run by Ataturk University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid consumption (time frame: postoperative 0-24 hours). 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 15 Jan 2021.