An interventional study of ketamine-lidocaine and Remifentanil in Pain, Postoperative, Pain, Acute and Pain, Chronic, sponsored by Evangelismos Hospital. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Evangelismos Hospital · Not applicable, Interventional, and Prevention
The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of lidocaine and ketamine in the same syringe versus remifentanyl analgesia in cervical spine surgery.
Cervical spine surgery is associated with medium pain scores and perioperative disability. Ketamine and lidocaine 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 and lidocaine. Sixty patients will be randomly allocated into two groups. The control group will receive a continuous infusion of remifentanil, while the Ketamine-Lidocaine (KL) group will receive a continuous infusion of ketamine and lidocaine, 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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Evangelismos Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Drug: ketamine-lidocaine
Drug: Remifentanil
In the KL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution
Also known as: KL 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
Also known as: Remifentanil group
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"
Time frame: immediately postoperatively]
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"
Time frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
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"
Time frame: 3 hours postoperatively
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"
Time frame: 6 hours postoperatively
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"
Time frame: 24 hours postoperatively
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
Time frame: immediately postoperatively
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
Time frame: at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
time to first request for analgesia
the time for the first patient request for analgesia will be noted
Time frame: during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
morphine consumption in Post-Anesthesia Care Unit (PACU)
mg of morphine requested during patient PACU stay
Time frame: immediately postoperatively
tramadol consumption in the first 48 hours
patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
Time frame: 48 hours postoperatively
fentanyl requirement during surgery
dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Time frame: intraoperatively
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
Time frame: 24 hours postoperatively
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Evangelismos Hospital