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Opioid-Free Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437589
Recruitment Status : Completed
First Posted : June 18, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos Ramirez Paesano, Servei Central d' Anestesiologia

Brief Summary:
Cranio-cervical instability (CCI) has been well identified in diseases regarding connective tissue, such as Ehlers-Danlos Syndrome/Hipermobility Type (EDS-HT). These patients frequently suffer from severe widespread pain with very difficult management and control. Chronic neuroinflamation, opioid-induced hyperalgesia, and central sensitization phenomena may explain this complex painful condition. A retrospective, observational, consecutive case series study is designed to determine if opioid-free anesthetic management shows a reduction in postoperative pain and opioid rescues needs in comparison with opioid-based anesthesia management for patients with EDS-HT undergoing crano-cervical fixation.

Condition or disease
Ehlers-Danlos Syndrome Craniocervical Syndrome

Detailed Description:

Cranio-cervical instability (CCI) has been well identified in diseases regarding connective tissue, such as Ehlers-Danlos Syndrome/Hipermobility Type (EDS-HT). These patients frequently suffer from severe widespread pain with very difficult management and control. Chronic neuroinflamation, opioid-induced hyperalgesia, and central sensitization phenomena may explain this complex painful condition. A retrospective, observational, consecutive case series study is designed to determine if opioid-free anesthetic management shows a reduction in postoperative pain and opioid rescues needs in comparison with opioid-based anesthesia management for patients with EDS-HT undergoing craneo-cervical fixation.

Main Aim: To determine if the administration of opioid-free anesthesia with propofol, lidocaine, ketamine, and dexmedetomidine shows reduction of postoperative pain, and postoperative needs of opioids rescue in patients undergoing CCF.

Secondary Aims:

  • To determine if the administration of opioid-free anesthesia in patients undergoing CCF, and postoperative Lidocaine, Ketamine, and Dexmedetomidine infusions can reduce the preoperative needs of opioids treatment at discharge time.
  • To determine if the administration of opioid-free anesthesia in patients undergoing CCF reduces the postoperative gastrointestinal complications.
  • To determine if the administration of postoperative Lidocaine, Ketamine, and Dexmedetomidine infusions in patients underwent CCF can reduce the preoperative needs of postoperative anxiolytic treatment.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Opioid-Free Intravenous Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series Study Focused on Anti-hyperalgesic Approach
Actual Study Start Date : September 6, 2018
Actual Primary Completion Date : March 9, 2020
Actual Study Completion Date : March 9, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Exposure group
In this group the treatment applied for postoperative pain involves Free-opioid anesthesia (LKDi).
Control group
In this group the treatment applied for postoperative pain involves an opioid-based anesthesia.



Primary Outcome Measures :
  1. Age [ Time Frame: Baseline ]
    Patient's age when the surgery was performed (in years)

  2. Sex [ Time Frame: Baseline ]
    Patient sex classified in two groups: female (1) and male (2)

  3. PO Analgesia [ Time Frame: Baseline ]

    Postoperative analgesia is a nominal variable which indicates the type of analgesia administered to the patient.

    There are 4 options: Lidocaine-Ketamine-Dexmetodimine (LKDi) as group 1, PCA morphine infusion pump as group 2, Ketamine perfusion as group 3 and Methadone-Ketamine as group 4.


  4. Preoperative EVA [ Time Frame: Baseline ]

    Escala Visual Analógica de dolor (EVA) is an analogic visual scale to measure the patients pain. It has a range between 0 and 10. Higher values mean more pain.

    The Preoperative EVA measures the pain before the surgery. If there is more than one measure the result is presented as the mean of all measurements.


  5. Preoperative Opioids [ Time Frame: Baseline ]

    The preoperative opioids is a categorical variable that indicates if the patient took opioids before the surgery.

    There are 4 options:

    • No opioids or eventually taken as option 0
    • Weak opioids (tramadol, codeine, trapentadol) as option 1
    • Strong opioids (fentanile, oxicodone, morphine, buprenorphine) as option 2
    • A combination of strong opioids as option 3

  6. Postoperative EVA 1 [ Time Frame: 1 day after surgery ]

    Escala Visual Analógica de dolor (EVA) is an analogic visual scale to measure the patients pain. It has a range between 0 and 10. Higher values mean more pain.

    The postoperative EVA 1 is measured 1 day after surgery.


  7. Postoperative EVA 2 [ Time Frame: 2 days after surgery ]

    Escala Visual Analógica de dolor (EVA) is an analogic visual scale to measure the patients pain. It has a range between 0 and 10. Higher values mean more pain.

    The postoperative EVA 2 is measured 2 day after surgery.


  8. Postoperative EVA 4 [ Time Frame: 4 days after surgery ]

    Escala Visual Analógica de dolor (EVA) is an analogic visual scale to measure the patients pain. It has a range between 0 and 10. Higher values mean more pain.

    The postoperative EVA 4 is measured 4 day after surgery.


  9. Postoperative EVA 6 [ Time Frame: 6 days after surgery ]

    Escala Visual Analógica de dolor (EVA) is an analogic visual scale to measure the patients pain. It has a range between 0 and 10. Higher values mean more pain.

    The postoperative EVA 6 is measured 6 day after surgery.


  10. Sufentanil doses 1 [ Time Frame: From surgery release till first day of hospitalization ]

    Number of pills of sufentanil that the patient has token besides the main treatment. The variable is gathered 1 day after surgery.

    Sufentanil doses 1 is a categorical variable with 4 levels:

    • From 0 to 2 pills (equal or less than 30mcg/day) as level 1.
    • From 2 to 4 pills (from 30mcg/day to 60mcg/day)
    • From 5 to 10 pills (from 75mcg/day to 150 mcg/day)
    • More than 10 pills (more than 150mcg/day)

  11. Sufentanil doses 2 [ Time Frame: From first day of hospitalization till second day of hospitalization ]

    Number of pills of sufentanil that the patient has token besides the main treatment. The variable is 2 days after surgery.

    Sufentanil doses 2 is a categorical variable with 4 levels:

    • From 0 to 2 pills (equal or less than 30mcg/day) as level 1.
    • From 2 to 4 pills (from 30mcg/day to 60mcg/day)
    • From 5 to 10 pills (from 75mcg/day to 150 mcg/day)
    • More than 10 pills (more than 150mcg/day)

  12. Sufentanil doses 4 [ Time Frame: From second day of hospitalization till fourth day of hospitalization ]

    Number of pills of sufentanil that the patient has token besides the main treatment. The variable is gathered 4 days after surgery.

    Sufentanil doses 4 is a categorical variable with 4 levels:

    • From 0 to 2 pills (equal or less than 30mcg/day) as level 1.
    • From 2 to 4 pills (from 30mcg/day to 60mcg/day)
    • From 5 to 10 pills (from 75mcg/day to 150 mcg/day)
    • More than 10 pills (more than 150mcg/day)

  13. Sufentanil doses 6 [ Time Frame: From fourth day of hospitalization till sixth day of hospitalization ]

    Number of pills of sufentanil that the patient has token besides the main treatment. The variable is gathered 6 days after surgery.

    Sufentanil doses 6 is a categorical variable with 4 levels:

    • From 0 to 2 pills (equal or less than 30mcg/day) as level 1.
    • From 2 to 4 pills (from 30mcg/day to 60mcg/day)
    • From 5 to 10 pills (from 75mcg/day to 150 mcg/day)
    • More than 10 pills (more than 150mcg/day)

  14. Rescue Methadone [ Time Frame: Baseline ]

    Rescue Methadone is a categorical variable that indicates if the patient required the use of methadone as a secondary treatment besides the main one.

    The variable has 4 levels:

    • No rescue as level 0
    • 5mg/day as level 1
    • From 10mg/day to 15mg/day as level 2
    • More than 15mg/day as level 3

  15. Morphine dosage 1 [ Time Frame: From surgery release till first day of hospitalization ]

    For those cases in which an infusion PCA morphine pump was placed, mean dose 1 day after surgery of the administered morphine.

    Daily morphine dosage is a categorical variable of 4 levels:

    • Less than 30mg/day as level 1
    • From 30mg/day to 60mg/day as level 2
    • From 60mg/day to 150mg/day as level 3
    • More than 150mg/day as level 4

  16. Morphine dosage 2 [ Time Frame: From first day of hospitalization till second day of hospitalization ]

    For those cases in which an infusion PCA morphine pump was placed, mean dose 2 days after surgery of the administered morphine.

    Daily morphine dosage is a categorical variable of 4 levels:

    • Less than 30mg/day as level 1
    • From 30mg/day to 60mg/day as level 2
    • From 60mg/day to 150mg/day as level 3
    • More than 150mg/day as level 4

  17. Morphine dosage 4 [ Time Frame: From second day of hospitalization till fourth day of hospitalization ]

    For those cases in which an infusion PCA morphine pump was placed, mean dose 4 days after surgery of the administered morphine.

    Daily morphine dosage is a categorical variable of 4 levels:

    • Less than 30mg/day as level 1
    • From 30mg/day to 60mg/day as level 2
    • From 60mg/day to 150mg/day as level 3
    • More than 150mg/day as level 4

  18. Morphine dosage 6 [ Time Frame: From fourth day of hospitalization till sixth day of hospitalization ]

    For those cases in which an infusion PCA morphine pump was placed, mean dose 6 days after surgery of the administered morphine.

    Daily morphine dosage is a categorical variable of 4 levels:

    • Less than 30mg/day as level 1
    • From 30mg/day to 60mg/day as level 2
    • From 60mg/day to 150mg/day as level 3
    • More than 150mg/day as level 4

  19. Nausea and vomiting [ Time Frame: Baseline ]
    Nausea and vomiting is a categorical variable that indicates if the patient reported having nausea or vomiting in the control postoperative visits. The variable has 2 states: Yes (1) or No (0).

  20. Intestinal ileus [ Time Frame: Baseline ]
    Intestinal ileus is a categorical variable that indicates if the doctor or nurse reported an intestinal ileus when performing the postoperative control visit. The variable has 2 states: Yes (1) or No (0).

  21. Constipation [ Time Frame: Baseline ]
    Constipation is a categorical variable that indicates if the patient reported having constipation in the control postoperative visits. The variable has 2 states: Yes (1) or No (0).

  22. Anxiolytic rescue agent [ Time Frame: Baseline ]

    The Anxiolytic rescue agent is a categorical variable that indicates if there was a need of applying an axiolytic as a rescue agent besides the main postoperative treatment.

    The variable has 5 levels:

    • Not required as level 0
    • Eventually (1 time per day) as level 1
    • Moderate (2 times per day) as level 2
    • Frequent (3 times per day) as level 3
    • Very Frequently (more than 3 times per day) as level 4

  23. Oral ketamine [ Time Frame: Baseline ]
    Oral ketamine is a categorical variable that indicates if the patient required the use of oral ketamine besides the main postoperative treatment. The variable has 2 states: Yes (1) or No (0).

  24. Chronic opioid and hospital discharge [ Time Frame: Up to 6 days ]

    The Chronic opioid and hospital discharge variable is a categorical variable that resumes the patient state when discharged from the hospital. The variable compares the preoperative opioid dosage with the postoperative dosage prescription.

    The variable has 4 levels:

    • No opioids as level 0
    • Decrease when compared to preoperative (between 20% and 30%) as level 1
    • Same dose when compared to preoperative as level 2
    • More dose when compared to preoperative as level 3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between 18-60 years with diagnosis of Hypermobility Syndrome undergoing Craneo-cervical fixation (CCF) between Sept, 2018 to March, 2020 to get stabilized craneo-cervical instability (CCI), and performed under opioid-based total intravenous anesthesia or opioid-free total intravenous anesthesia with lidocaine, ketamine and dexmedetomidine (LKD).
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of Hypermobility Syndrome undergoing Craneo-cervical fixation (CCF)
  • Patients between 18-60 years.
  • Patients enrolled in CCF surgery between September 2018 to March 2020 to get stabilized craneo-cervical instability (CCI).
  • Patients under opioid-based total intravenous anesthesia or opioid-free total intravenous anesthesia with lidocaine, ketamine and dexmedetomidine (LKD).

Exclusion Criteria:

  • CCF to stabilized post-traumatic or oncologic CCI.
  • Lidocaine allergy.
  • Advances heart-block.
  • Epilepsy or convulsive syndrome non-medicated.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437589


Locations
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Spain
Centro Médico Teknon
Barcelona, Spain, 08022
Sponsors and Collaborators
Servei Central d' Anestesiologia
Investigators
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Principal Investigator: Carlos Rafael Ramirez Paesano, MD Servei d'Anestesiologia Centro Médico Teknon
Publications:

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Responsible Party: Carlos Ramirez Paesano, Principal Investigator, Servei Central d' Anestesiologia
ClinicalTrials.gov Identifier: NCT04437589    
Other Study ID Numbers: OPIOIDANALGESIA1
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Ramirez Paesano, Servei Central d' Anestesiologia:
Craneocervical -instability
Craneocervical -fixation
Opioid induced hyperalgesia
Free-opioid-anesthesia
Ehlers-Danlos Syndrome
Joint Hipermobility syndrome
Central sensitization phenomena
Additional relevant MeSH terms:
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Joint Instability
Ehlers-Danlos Syndrome
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases