Opioid Sparing Anesthesia in Lumbar Spine Surgery
- Conditions
- Pain, AcuteKetamineLidocainePain, NociceptiveDexmedetomidineAnalgesiaAnalgesicsLumbar Spine SurgeryPain, PostoperativePain, Chronic
- Interventions
- Drug: dexmedetomidine-ketamine-lidocaine
- Registration Number
- NCT05594407
- Lead Sponsor
- Aretaieion University Hospital
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Adult patents
- American Society of Anesthesiologists (ASA) class I-III
- elective spine surgery
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dexmedetomidine-ketamine-lidocaine (DKL) group dexmedetomidine-ketamine-lidocaine combination of dexmedetomidine, ketamine and lidocaine in one syringe remifentanil group Remifentanil syringe of remifentanil
- Primary Outcome Measures
Name Time Method pain score on arrival to Post-Anesthesia Care Unit (PACU) immediately postoperatively 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"
pain score at discharge from Post-Anesthesia Care Unit (PACU) at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively 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"
pain score 3 hours postoperatively 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"
pain score 6 hours postoperatively 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"
pain score 24 hours postoperatively 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"
- Secondary Outcome Measures
Name Time Method time to first request for analgesia during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively the time for the first patient request for analgesia will be noted
sedation on arrival to Post-Anesthesia Care Unit immediately postoperatively 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
sedation at discharge from Post-Anesthesia Care (PACU) Unit at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively 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
morphine consumption in Post-Anesthesia Care Unit (PACU) immediately postoperatively mg of morphine requested during patient PACU stay
tramadol consumption in the first 48 hours 48 hours postoperatively patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
fentanyl requirement during surgery intraoperatively dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
satisfaction from postoperative analgesia 24 hours postoperatively satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
Trial Locations
- Locations (1)
Evangelismos General Hospital
🇬🇷Athens, Greece