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Pain, PostoperativeNCT05594407

Opioid Sparing Anesthesia in Lumbar Spine Surgery

A study testing dexmedetomidine-ketamine-lidocaine and Remifentanil in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus remifentanil analgesia in lumbar spine surgery Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Postoperative, Pain, Acute, Pain, Chronic
What is being tested?
dexmedetomidine-ketamine-lidocaine and Remifentanil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGreece
Study dates
1 Aug 2022to 1 Aug 2024
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult patents
  • American Society of Anesthesiologists (ASA) class I-III
  • elective spine surgery

Who cannot join

  • body mass index (BMI) >35 kg/m2
  • contraindications to local anesthetic administration
  • systematic use of analgesic agents preoperatively
  • chronic pain syndromes preoperatively
  • neurological or psychiatric disease on treatment
  • pregnancy
Show all 11Show fewer
  • severe hepatic or renal disease
  • history of cardiovascular diseases/ arrhythmias/ conduction abnormalities
  • bradycardia(<55 beats/minute)
  • drug or alcohol abuse
  • language or communication barriers lack of informed consent

Trial locations and contacts

1 site in 1 country.

Kassiani Theodoraki, PhD, DESA contact

+306974634162

ktheodoraki@hotmail.com

Athanasios Vaiopoulos, MD contact

thanasisvaio@gmail.com

Greece1 site, 1 recruiting

  • Evangelismos General Hospital

    Athens

    Athanasios Vaiopoulos, MD, thanasisvaio@gmail.com

    Recruiting

Other trials in Greece

About this study

Official title: The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery

The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus remifentanil analgesia in lumbar spine surgery

Read the detailed description

Lumbar spine surgery is associated with high pain scores and perioperative disability. Ketamine, lidocaine and dexmedetomidine have all proven but varied analgesic effects. High opioid consumption has been associated with multiple side effects.

This double blind clinical trial aims to investigate the possible reduction of opioid use during lumbar spine surgery by administering ketamine, lidocaine and dexmedetomidine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Dexmedetomidine-Ketamine-Lidocaine (DKL) group will receive a continuous infusion of ketamine, lidocaine and dexmedetomidine, during the surgery and shortly after

Both infusions will be administered blindly. Fentanyl and morphine will be administered to each patient so as to maintain hemodynamic stability and pain relief. The study will eventually compare the need for bolus doses of fentanyl during the surgery and morphine shortly after in each group.

Multiple hemodynamic parameters, analgesic consumption, possible side effects, patient satisfaction and the Oswestry low back pain disability questionnaire will be recorded.

Being tested
dexmedetomidine-ketamine-lidocaine, Remifentanil
Medical subject headings
Pain, Postoperative, Acute Pain, Chronic Pain, Nociceptive Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexmedetomidine-ketamine-lidocaineDrug

    Also called DKL group

    In the DKL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution

  • RemifentanilDrug

    Also called Remifentanil group

    In the Remifentanil group, patients will be administered in a total volume of 20 mL, 2 mcg/kg of fentanyl. As maintenance, they will be receiving 1 mL/10kg/h of a remifentanil solution

Study groups in NCT05594407
Study groupRoleWhat they receive
dexmedetomidine-ketamine-lidocaine (DKL) groupActive comparatorcombination of dexmedetomidine, ketamine and lidocaine in one syringe
Receives: Drug: dexmedetomidine-ketamine-lidocaine
remifentanil groupActive comparatorsyringe of remifentanil
Receives: Drug: Remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain score on arrival to Post-Anesthesia Care Unit (PACU)

    pain score by the use of Numeric Rating Scale (NRS) on arrival to PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    Measured: immediately postoperatively

  2. pain score at discharge from Post-Anesthesia Care Unit (PACU)

    pain score by the use of Numeric Rating Scale (NRS) at discharge from PACU, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    Measured: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

  3. pain score 3 hours postoperatively

    pain score by the use of Numeric Rating Scale (NRS) 3 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    Measured: 3 hours postoperatively

  4. pain score 6 hours postoperatively

    pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    Measured: 6 hours postoperatively

  5. pain score 24 hours postoperatively

    pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    Measured: 24 hours postoperatively

Secondary outcomes (7)

  1. sedation on arrival to Post-Anesthesia Care Unit

    sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain

    Measured: immediately postoperatively

  2. sedation at discharge from Post-Anesthesia Care (PACU) Unit

    sedation will be assessed with a 5-point sedation scale, where: 1, patient perfectly conscious; 2, patient feels a little drowsy; 3, patient seems to be sleeping but immediately reacts to verbal stimulation; 4, patient seems to be sleeping but slowly reacts to verbal stimulation and 5, patient seems to be sleeping and does not react to verbal stimulation but does react to a stimulus such as shaking or pain

    Measured: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

  3. time to first request for analgesia

    the time for the first patient request for analgesia will be noted

    Measured: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively

  4. morphine consumption in Post-Anesthesia Care Unit (PACU)

    mg of morphine requested during patient PACU stay

    Measured: immediately postoperatively

  5. tramadol consumption in the first 48 hours

    patients will be followed for cumulative tramadol consumption for 48 hours postoperatively

    Measured: 48 hours postoperatively

  6. fentanyl requirement during surgery

    dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value

    Measured: intraoperatively

  7. satisfaction from postoperative analgesia

    satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction

    Measured: 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594407
Sponsor's protocol ID
254/13-07-2022
Status last verified
Oct 2022
First submitted
21 Oct 2022
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Licina A, Silvers A. Perioperative Intravenous Lidocaine Infusion for Postoperative Analgesia in Patients Undergoing Surgery of the Spine: Systematic Review and Meta-Analysis. Pain Med. 2022 Jan 3;23(1):45-56. doi: 10.1093/pm/pnab210.

    PubMed 34196720

  • Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.

    PubMed 29739537

  • Jabbour HJ, Naccache NM, Jawish RJ, Abou Zeid HA, Jabbour KB, Rabbaa-Khabbaz LG, Ghanem IB, Yazbeck PH. Ketamine and magnesium association reduces morphine consumption after scoliosis surgery: prospective randomised double-blind study. Acta Anaesthesiol Scand. 2014 May;58(5):572-9. doi: 10.1111/aas.12304. Epub 2014 Mar 17.

    PubMed 24635528

  • Waelkens P, Alsabbagh E, Sauter A, Joshi GP, Beloeil H; PROSPECT Working group * * of the European Society of Regional Anaesthesia and Pain therapy (ESRA). Pain management after complex spine surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol. 2021 Sep 1;38(9):985-994. doi: 10.1097/EJA.0000000000001448.

    PubMed 34397527

Questions about this trial

What is this clinical trial studying?

A study testing dexmedetomidine-ketamine-lidocaine and Remifentanil in people with Pain, Postoperative and Pain, Acute, run by Aretaieion University Hospital at 1 site in Greece.

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 11 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 31 Oct 2022. 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 Greece. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kassiani Theodoraki, PhD, DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score on arrival to Post-Anesthesia Care Unit (PACU) (time frame: immediately postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05594407, which also lists 4 linked publications.

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 31 Oct 2022; AzTrials last refreshed its copy on 26 Oct 2026.

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