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

Primary outcomes

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