Ehlers-Danlos SyndromeNCT04437589
Opioid-Free Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series
An observational study of Ehlers-Danlos Syndrome and Craniocervical Syndrome, run by Servei Central d'Anestesiologia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ehlers-Danlos Syndrome, Craniocervical Syndrome
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 6 Sep 2018to 9 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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).
Who cannot join
- CCF to stabilized post-traumatic or oncologic CCI.
- Lidocaine allergy.
- Advances heart-block.
- Epilepsy or convulsive syndrome non-medicated.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Ehlers-Danlos Syndrome, Craniocervical Syndrome
- Keywords
- Craneocervical -instability, Craneocervical -fixation, Opioid induced hyperalgesia, Free-opioid-anesthesia, Ehlers-Danlos Syndrome, Joint Hipermobility syndrome, Central sensitization phenomena
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Patient's age when the surgery was performed (in years)
Measured: Baseline
Sex
Patient sex classified in two groups: female (1) and male (2)
Measured: Baseline
PO Analgesia
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.
Measured: Baseline
Preoperative EVA
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.
Measured: Baseline
Preoperative Opioids
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
Measured: Baseline
Postoperative EVA 1
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.
Measured: 1 day after surgery
Postoperative EVA 2
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.
Measured: 2 days after surgery
Postoperative EVA 4
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.
Measured: 4 days after surgery
Postoperative EVA 6
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.
Measured: 6 days after surgery
Sufentanil doses 1
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)
Measured: From surgery release till first day of hospitalization
Sufentanil doses 2
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)
Measured: From first day of hospitalization till second day of hospitalization
Sufentanil doses 4
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)
Measured: From second day of hospitalization till fourth day of hospitalization
Sufentanil doses 6
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)
Measured: From fourth day of hospitalization till sixth day of hospitalization
Rescue Methadone
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
Measured: Baseline
Morphine dosage 1
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
Measured: From surgery release till first day of hospitalization
Morphine dosage 2
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
Measured: From first day of hospitalization till second day of hospitalization
Morphine dosage 4
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
Measured: From second day of hospitalization till fourth day of hospitalization
Morphine dosage 6
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
Measured: From fourth day of hospitalization till sixth day of hospitalization
Nausea and vomiting
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).
Measured: Baseline
Intestinal ileus
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).
Measured: Baseline
Constipation
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).
Measured: Baseline
Anxiolytic rescue agent
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
Measured: Baseline
Oral ketamine
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).
Measured: Baseline
Chronic opioid and hospital discharge
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
Measured: Up to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start6 Sep 2018
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servei Central d'Anestesiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Ramirez Paesano, Servei Central d'Anestesiologia
- Investigators
- Carlos Rafael Ramirez Paesano, MD, Principal investigator, Servei d'Anestesiologia Centro Médico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437589
- Sponsor's protocol ID
- OPIOIDANALGESIA1
- Status last verified
- Jul 2020
- First submitted
- 11 Jun 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castori M, Morlino S, Ghibellini G, Celletti C, Camerota F, Grammatico P. Connective tissue, Ehlers-Danlos syndrome(s), and head and cervical pain. Am J Med Genet C Semin Med Genet. 2015 Mar;169C(1):84-96. doi: 10.1002/ajmg.c.31426. Epub 2015 Feb 5.
PubMed 25655119Henderson FC Sr, Francomano CA, Koby M, Tuchman K, Adcock J, Patel S. Cervical medullary syndrome secondary to craniocervical instability and ventral brainstem compression in hereditary hypermobility connective tissue disorders: 5-year follow-up after craniocervical reduction, fusion, and stabilization. Neurosurg Rev. 2019 Dec;42(4):915-936. doi: 10.1007/s10143-018-01070-4. Epub 2019 Jan 9.
PubMed 30627832Scheper MC, de Vries JE, Verbunt J, Engelbert RH. Chronic pain in hypermobility syndrome and Ehlers-Danlos syndrome (hypermobility type): it is a challenge. J Pain Res. 2015 Aug 20;8:591-601. doi: 10.2147/JPR.S64251. eCollection 2015.
PubMed 26316810Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011 Mar-Apr;14(2):145-61.
PubMed 21412369Kim DJ, Bengali R, Anderson TA. Opioid-free anesthesia using continuous dexmedetomidine and lidocaine infusions in spine surgery. Korean J Anesthesiol. 2017 Dec;70(6):652-653. doi: 10.4097/kjae.2017.70.6.652. Epub 2017 Apr 21. No abstract available.
PubMed 29225750Soffin EM, Wetmore DS, Beckman JD, Sheha ED, Vaishnav AS, Albert TJ, Gang CH, Qureshi SA. Opioid-free anesthesia within an enhanced recovery after surgery pathway for minimally invasive lumbar spine surgery: a retrospective matched cohort study. Neurosurg Focus. 2019 Apr 1;46(4):E8. doi: 10.3171/2019.1.FOCUS18645.
PubMed 30933925Maheshwari K, Avitsian R, Sessler DI, Makarova N, Tanios M, Raza S, Traul D, Rajan S, Manlapaz M, Machado S, Krishnaney A, Machado A, Rosenquist R, Kurz A. Multimodal Analgesic Regimen for Spine Surgery: A Randomized Placebo-controlled Trial. Anesthesiology. 2020 May;132(5):992-1002. doi: 10.1097/ALN.0000000000003143.
PubMed 32235144Dunn LK, Durieux ME, Nemergut EC. Non-opioid analgesics: Novel approaches to perioperative analgesia for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):79-89. doi: 10.1016/j.bpa.2015.11.002. Epub 2015 Nov 24.
PubMed 27036605Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
PubMed 30802933
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04437589
- Acronym / sponsor ID
- OPIOIDANALGESIA1
- Conditions
- Ehlers-Danlos Syndrome, Craniocervical Syndrome
- Keywords
- Craneocervical -instability, Craneocervical -fixation, Opioid induced hyperalgesia, Free-opioid-anesthesia, Ehlers-Danlos Syndrome, Joint Hipermobility syndrome, Central sensitization phenomena
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Servei Central d'AnestesiologiaUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- CCF to stabilized post-traumatic or oncologic CCI.
- Lidocaine allergy.
- Advances heart-block.
- Epilepsy or convulsive syndrome non-medicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age
Time frame: Baseline
Patient's age when the surgery was performed (in years)
Sex
Time frame: Baseline
Patient sex classified in two groups: female (1) and male (2)
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.
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.
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
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.
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.
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.
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.
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)
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)
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)
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)
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
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
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
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
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
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).
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).
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).
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
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).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Background: PubMed 25655119Castori M, Morlino S, Ghibellini G, Celletti C, Camerota F, Grammatico P. Connective tissue, Ehlers-Danlos syndrome(s), and head and cervical pain. Am J Med Genet C Semin Med Genet. 2015 Mar;169C(1):84-96. doi: 10.1002/ajmg.c.31426. Epub 2015 Feb 5.
- Background: PubMed 30627832Henderson FC Sr, Francomano CA, Koby M, Tuchman K, Adcock J, Patel S. Cervical medullary syndrome secondary to craniocervical instability and ventral brainstem compression in hereditary hypermobility connective tissue disorders: 5-year follow-up after craniocervical reduction, fusion, and stabilization. Neurosurg Rev. 2019 Dec;42(4):915-936. doi: 10.1007/s10143-018-01070-4. Epub 2019 Jan 9.
- Background: PubMed 26316810Scheper MC, de Vries JE, Verbunt J, Engelbert RH. Chronic pain in hypermobility syndrome and Ehlers-Danlos syndrome (hypermobility type): it is a challenge. J Pain Res. 2015 Aug 20;8:591-601. doi: 10.2147/JPR.S64251. eCollection 2015.
- Background: PubMed 21412369Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011 Mar-Apr;14(2):145-61.
- Background: PubMed 29225750Kim DJ, Bengali R, Anderson TA. Opioid-free anesthesia using continuous dexmedetomidine and lidocaine infusions in spine surgery. Korean J Anesthesiol. 2017 Dec;70(6):652-653. doi: 10.4097/kjae.2017.70.6.652. Epub 2017 Apr 21. No abstract available.
- Background: PubMed 30933925Soffin EM, Wetmore DS, Beckman JD, Sheha ED, Vaishnav AS, Albert TJ, Gang CH, Qureshi SA. Opioid-free anesthesia within an enhanced recovery after surgery pathway for minimally invasive lumbar spine surgery: a retrospective matched cohort study. Neurosurg Focus. 2019 Apr 1;46(4):E8. doi: 10.3171/2019.1.FOCUS18645.
- Background: PubMed 32235144Maheshwari K, Avitsian R, Sessler DI, Makarova N, Tanios M, Raza S, Traul D, Rajan S, Manlapaz M, Machado S, Krishnaney A, Machado A, Rosenquist R, Kurz A. Multimodal Analgesic Regimen for Spine Surgery: A Randomized Placebo-controlled Trial. Anesthesiology. 2020 May;132(5):992-1002. doi: 10.1097/ALN.0000000000003143.
- Background: PubMed 27036605Dunn LK, Durieux ME, Nemergut EC. Non-opioid analgesics: Novel approaches to perioperative analgesia for major spine surgery. Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):79-89. doi: 10.1016/j.bpa.2015.11.002. Epub 2015 Nov 24.
- Background: PubMed 30802933Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Rafael Ramirez Paesano, MD principal investigator
Servei d'Anestesiologia Centro Médico Teknon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ehlers-Danlos Syndrome and Craniocervical Syndrome, run by Servei Central d'Anestesiologia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: Baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437589, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.