Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine-ketamine-lidocaine (DKL) group | Active Comparator | combination of dexmedetomidine, ketamine and lidocaine in one syringe |
|
| remifentanil group | Active Comparator | syringe of remifentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Contact | +306974634162 | ktheodoraki@hotmail.com | |
| Athanasios Vaiopoulos, MD | Contact | thanasisvaio@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kassiani Theodoraki | Aretaieion University Hospital, Athens, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelismos General Hospital | Recruiting | Athens | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34196720 | Background | Licina A, Silvers A. Perioperative Intravenous Lidocaine Infusion for Postoperative Analgesia in Patients Undergoing Surgery of the Spine: Systematic Review and Meta-Analysis. Pain Med. 2022 Jan 3;23(1):45-56. doi: 10.1093/pm/pnab210. | |
| 29739537 | Background | Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| D059226 | Nociceptive Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
|
|
| immediately postoperatively |
| 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 |
| 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 |
| morphine consumption in Post-Anesthesia Care Unit (PACU) | mg of morphine requested during patient PACU stay | immediately postoperatively |
| tramadol consumption in the first 48 hours | patients will be followed for cumulative tramadol consumption for 48 hours postoperatively | 48 hours postoperatively |
| 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 |
| 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 |
| 24635528 | Background | Jabbour HJ, Naccache NM, Jawish RJ, Abou Zeid HA, Jabbour KB, Rabbaa-Khabbaz LG, Ghanem IB, Yazbeck PH. Ketamine and magnesium association reduces morphine consumption after scoliosis surgery: prospective randomised double-blind study. Acta Anaesthesiol Scand. 2014 May;58(5):572-9. doi: 10.1111/aas.12304. Epub 2014 Mar 17. |
| 34397527 | Background | Waelkens P, Alsabbagh E, Sauter A, Joshi GP, Beloeil H; PROSPECT Working group * * of the European Society of Regional Anaesthesia and Pain therapy (ESRA). Pain management after complex spine surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol. 2021 Sep 1;38(9):985-994. doi: 10.1097/EJA.0000000000001448. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |