Opioid Sparing Anesthesia in Lumbar Spine Surgery

Ketamine

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

Intervention / Treatment

dexmedetomidine-ketamine-lidocaine (DRUG)

In the DKL group, patients will be administered in a total volume of 20 mL,1mL/10 kg of the solution containing ketamine, lidocaine and dexmedetomidine at predefined concentrations. As maintenance, they will be receiving 1mL/10kg/h of the aforementioned solution
Remifentanil (DRUG)

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

Condition or Disease

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

Phase

Not Applicable

Study Design

Study type:	INTERVENTIONAL
Status:	Recruiting
Study results:	No Results Available
Age:	18 Years to 75 Years
Enrollment:	60 (ESTIMATED)
Allocation:	Randomized
Primary Purpose:	Prevention
Masking QUADRUPLE: Participant Care Provider Investigator Outcomes Assessor

Clinical Trial Dates

Start date:	Aug 01, 2022	ACTUAL
Primary Completion:	Aug 01, 2024	ESTIMATED
Completion Date:	Aug 01, 2024	ESTIMATED
Study First Posted:	Oct 26, 2022	ACTUAL
Last Updated:	Oct 27, 2022

Sponsors / Collaborators

Lead Sponsor: N/A

Responsible Party: N/A

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.

Participant Groups

combination of dexmedetomidine, ketamine and lidocaine in one syringe
syringe of remifentanil

Eligibility Criteria

Sex:	All
Minimum Age:	18
Maximum Age:	75
Age Groups:	Adult / Older Adult
Healthy Volunteers:	Yes

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

This clinical trial is recruiting

Are you interested in participating in this trial or others? We'd love to help.

Primary Outcomes

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 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 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 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 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

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
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
the time for the first patient request for analgesia will be noted
mg of morphine requested during patient PACU stay
patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction

More Details

NCT Number:	NCT05594407
Other IDs:	254/13-07-2022
Study URL:	https://clinicaltrials.gov/study/NCT05594407

Last updated: Sep 29, 2023