NCT05717361

Opioid Sparing Anesthesia in Cervical Spine Surgery

The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Evangelismos Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pain, Postoperative
• Pain, Acute
• Pain, Chronic
• Pain, Nociceptive
• Ketamine
• Lidocaine
• Analgesia
• Analgesics
• Cervical Spine Surgery

Interventions

Type	Name	Description
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
DRUG	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

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Greece