Opioid Sparing Anesthesia in Cervical Spine Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717361
• Other study ID #: 254/13-07-2022?
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2023
• Source: Evangelismos Hospital
• Contact: Kassiani Theodoraki, PhD, DESA
• Phone: +306974634162
• Email: ktheodoraki[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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

Locations

Country	Name	City	State
Greece	Evangelismos General Hospital	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Evangelismos Hospital	Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score on arrival to Post-Anesthesia Care Unit (PACU)	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"	immediately postoperatively]
Primary	pain score at discharge from Post-Anesthesia Care Unit (PACU)	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"	at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Primary	pain score 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"	3 hours postoperatively
Primary	pain score 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"	6 hours postoperatively
Primary	pain score 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"	24 hours postoperatively
Secondary	sedation on arrival to Post-Anesthesia Care Unit	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	immediately postoperatively
Secondary	sedation at discharge from Post-Anesthesia Care (PACU) Unit	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	at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Secondary	time to first request for analgesia	the time for the first patient request for analgesia will be noted	during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Secondary	morphine consumption in Post-Anesthesia Care Unit (PACU)	mg of morphine requested during patient PACU stay	immediately postoperatively
Secondary	tramadol consumption in the first 48 hours	patients will be followed for cumulative tramadol consumption for 48 hours postoperatively	48 hours postoperatively
Secondary	fentanyl requirement during surgery	dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value	intraoperatively
Secondary	satisfaction from postoperative analgesia	satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction	24 hours postoperatively