Clinical trial NCT04437589: Opioid-Free Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Servei Central d'Anestesiologia
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

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.

Eligibility 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.

Primary outcomes:
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: PO Analgesia
timeFrame: Baseline
measure: Preoperative EVA
timeFrame: Baseline
measure: Preoperative Opioids
timeFrame: Baseline
measure: Postoperative EVA 1
timeFrame: 1 day after surgery
measure: Postoperative EVA 2
timeFrame: 2 days after surgery
measure: Postoperative EVA 4
timeFrame: 4 days after surgery
measure: Postoperative EVA 6
timeFrame: 6 days after surgery
measure: Sufentanil doses 1
timeFrame: From surgery release till first day of hospitalization
measure: Sufentanil doses 2
timeFrame: From first day of hospitalization till second day of hospitalization
measure: Sufentanil doses 4
timeFrame: From second day of hospitalization till fourth day of hospitalization
measure: Sufentanil doses 6
timeFrame: From fourth day of hospitalization till sixth day of hospitalization
measure: Rescue Methadone
timeFrame: Baseline
measure: Morphine dosage 1
timeFrame: From surgery release till first day of hospitalization
measure: Morphine dosage 2
timeFrame: From first day of hospitalization till second day of hospitalization
measure: Morphine dosage 4
timeFrame: From second day of hospitalization till fourth day of hospitalization
measure: Morphine dosage 6
timeFrame: From fourth day of hospitalization till sixth day of hospitalization
measure: Nausea and vomiting
timeFrame: Baseline
measure: Intestinal ileus
timeFrame: Baseline
measure: Constipation
timeFrame: Baseline
measure: Anxiolytic rescue agent
timeFrame: Baseline
measure: Oral ketamine
timeFrame: Baseline
measure: Chronic opioid and hospital discharge
timeFrame: Up to 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Médico Teknon
Study officials:
affiliation: Servei d'Anestesiologia Centro Médico Teknon
name: Carlos Rafael Ramirez Paesano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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