The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery
Overview
- Phase
- N/A
- Intervention
- ketamine-lidocaine
- Conditions
- Pain, Postoperative
- Sponsor
- Evangelismos Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- pain score at discharge from Post-Anesthesia Care Unit (PACU)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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 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.
Investigators
Athanasios Vaiopoulos
Anesthesia Resident
Evangelismos Hospital
Eligibility Criteria
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
Arms & Interventions
ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe
Intervention: ketamine-lidocaine
: remifentanil group syringe of remifentanil
Intervention: Remifentanil
Outcomes
Primary Outcomes
pain score at discharge from Post-Anesthesia Care Unit (PACU)
Time Frame: 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 on arrival to Post-Anesthesia Care Unit (PACU)
Time Frame: 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 3 hours postoperatively
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- tramadol consumption in the first 48 hours(48 hours postoperatively)
- time to first request for analgesia(during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively)
- sedation at discharge from Post-Anesthesia Care (PACU) Unit(at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively)
- morphine consumption in Post-Anesthesia Care Unit (PACU)(immediately postoperatively)
- satisfaction from postoperative analgesia(24 hours postoperatively)
- sedation on arrival to Post-Anesthesia Care Unit(immediately postoperatively)
- fentanyl requirement during surgery(intraoperatively)