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Opioid Sparing Anesthesia in Cervical Spine Surgery

Primary Purpose

Pain, Postoperative, Pain, Acute, Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
ketamine-lidocaine
Remifentanil
Sponsored by
Evangelismos 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

ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe

: remifentanil group syringe of remifentanil

Arm Description

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
January 28, 2023
Last Updated
January 28, 2023
Sponsor
Evangelismos Hospital
Collaborators
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05717361
Brief Title
Opioid Sparing Anesthesia in Cervical 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
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evangelismos Hospital
Collaborators
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 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.

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, Analgesia, Analgesics, Cervical 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
ketamine-lidocaine (KL) group combination of ketamine and lidocaine in one syringe
Arm Type
Active Comparator
Arm Title
: remifentanil group syringe of remifentanil
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ketamine-lidocaine
Other Intervention Name(s)
KL group
Intervention Description
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
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
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
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
First Name & Middle Initial & Last Name & Degree
Athanasios Vaiopoulos

12. IPD Sharing Statement

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Opioid Sparing Anesthesia in Cervical Spine Surgery

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