Opioid Sparing Anesthesia in Cervical Spine Surgery

Evangelismos Hospital

Status: Enrolling

Conditions: Analgesics; Cervical Spine Surgery; Lidocaine; Ketamine; Pain, Acute; Pain, Postoperative; Pain, Chronic; Analgesia; Pain, Nociceptive

Treatments: Drug: ketamine-lidocaine; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05717361

254/13-07-2022Β

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe

Active Comparator group

Treatment:

Drug: ketamine-lidocaine

: remifentanil group syringe of remifentanil

Active Comparator group

Treatment:

Drug: Remifentanil