Opioid Sparing Anesthesia in Lumbar Spine Surgery

Aretaieion University Hospital

Status: Enrolling

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

Treatments: Drug: Remifentanil; Drug: dexmedetomidine-ketamine-lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05594407

254/13-07-2022

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 dexmedetomidine-lidocaine-ketamine in the same syringe versus remifentanil analgesia in lumbar spine surgery

Full 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.

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

---

60 participants in 2 patient groups

dexmedetomidine-ketamine-lidocaine (DKL) group

Active Comparator group

Description:

combination of dexmedetomidine, ketamine and lidocaine in one syringe

Treatment:

Drug: dexmedetomidine-ketamine-lidocaine

remifentanil group

Active Comparator group

Description:

syringe of remifentanil

Treatment:

Drug: Remifentanil