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Opioid Sparing Anesthesia in Lumbar Spine Surgery

Primary Purpose

Pain, Postoperative, Pain, Acute, Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
dexmedetomidine-ketamine-lidocaine
Remifentanil
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Evangelismos General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmedetomidine-ketamine-lidocaine (DKL) group

remifentanil group

Arm Description

combination of dexmedetomidine, ketamine and lidocaine in one syringe

syringe of remifentanil

Outcomes

Primary Outcome Measures

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"
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"
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"
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"
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"

Secondary Outcome Measures

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
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
time to first request for analgesia
the time for the first patient request for analgesia will be noted
morphine consumption in Post-Anesthesia Care Unit (PACU)
mg of morphine requested during patient PACU stay
tramadol consumption in the first 48 hours
patients will be followed for cumulative tramadol consumption for 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
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

Full Information

First Posted
October 21, 2022
Last Updated
October 27, 2022
Sponsor
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05594407
Brief Title
Opioid Sparing Anesthesia in Lumbar Spine Surgery
Official Title
The Effect of a Regimen of Opioid Sparing Anesthesia on Postoperative Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Acute, Pain, Chronic, Pain, Nociceptive, Ketamine, Lidocaine, Dexmedetomidine, Analgesia, Analgesics, Lumbar Spine Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine-ketamine-lidocaine (DKL) group
Arm Type
Active Comparator
Arm Description
combination of dexmedetomidine, ketamine and lidocaine in one syringe
Arm Title
remifentanil group
Arm Type
Active Comparator
Arm Description
syringe of remifentanil
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine-ketamine-lidocaine
Other Intervention Name(s)
DKL group
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Remifentanil group
Intervention Description
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
Primary Outcome Measure Information:
Title
pain score on arrival to Post-Anesthesia Care Unit (PACU)
Description
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"
Time Frame
immediately postoperatively
Title
pain score at discharge from Post-Anesthesia Care Unit (PACU)
Description
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"
Time Frame
at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
pain score 3 hours postoperatively
Description
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"
Time Frame
3 hours postoperatively
Title
pain score 6 hours postoperatively
Description
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"
Time Frame
6 hours postoperatively
Title
pain score 24 hours postoperatively
Description
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"
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
sedation on arrival to Post-Anesthesia Care Unit
Description
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
Time Frame
immediately postoperatively
Title
sedation at discharge from Post-Anesthesia Care (PACU) Unit
Description
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
Time Frame
at discharge from Post Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
time to first request for analgesia
Description
the time for the first patient request for analgesia will be noted
Time Frame
during stay in Post-Anesthesia Care Unit (PACU), approximately 1 hour postoperatively
Title
morphine consumption in Post-Anesthesia Care Unit (PACU)
Description
mg of morphine requested during patient PACU stay
Time Frame
immediately postoperatively
Title
tramadol consumption in the first 48 hours
Description
patients will be followed for cumulative tramadol consumption for 48 hours postoperatively
Time Frame
48 hours postoperatively
Title
fentanyl requirement during surgery
Description
dose of required fentanyl intraoperatively to maintain systolic arterial blood pressure and heart rate within the 20% of baseline value
Time Frame
intraoperatively
Title
satisfaction from postoperative analgesia
Description
satisfaction from postoperative analgesia on a six-point Likert scale with 1 marked as minimal satisfaction and 6 as maximal satisfaction
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 language or communication barriers lack of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kassiani Theodoraki, PhD, DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Athanasios Vaiopoulos, MD
Email
thanasisvaio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki
Organizational Affiliation
Aretaieion University Hospital, Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evangelismos General Hospital
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanasios Vaiopoulos, MD
Email
thanasisvaio@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
34196720
Citation
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.
Results Reference
background
PubMed Identifier
29739537
Citation
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.
Results Reference
background
PubMed Identifier
24635528
Citation
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.
Results Reference
background
PubMed Identifier
34397527
Citation
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.
Results Reference
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Opioid Sparing Anesthesia in Lumbar Spine Surgery

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