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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05717361
Other study ID # 254/13-07-2022?
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date November 1, 2024

Study information

Verified date January 2023
Source Evangelismos Hospital
Contact Kassiani Theodoraki, PhD, DESA
Phone +306974634162
Email ktheodoraki@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 lidocaine and ketamine in the same syringe versus remifentanyl analgesia in cervical spine surgery.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Adult patents - American Society of Anesthesiologists (ASA) class I-III - elective spine surgery Exclusion Criteria: - 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 - 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

Study Design


Intervention

Drug:
ketamine-lidocaine
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
Remifentanil
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

Locations

Country Name City State
Greece Evangelismos General Hospital Athens

Sponsors (2)

Lead Sponsor Collaborator
Evangelismos Hospital Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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" immediately postoperatively]
Primary 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" at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Primary 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" 3 hours postoperatively
Primary 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" 6 hours postoperatively
Primary 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" 24 hours postoperatively
Secondary 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 immediately postoperatively
Secondary 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 at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Secondary time to first request for analgesia the time for the first patient request for analgesia will be noted during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Secondary morphine consumption in Post-Anesthesia Care Unit (PACU) mg of morphine requested during patient PACU stay immediately postoperatively
Secondary tramadol consumption in the first 48 hours patients will be followed for cumulative tramadol consumption for 48 hours postoperatively 48 hours postoperatively
Secondary fentanyl requirement during surgery dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value intraoperatively
Secondary 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 24 hours postoperatively
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