- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04437589
Opioid-Free Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series
Opioid-Free Intravenous Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series Study Focused on Anti-hyperalgesic Approach
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08022
- Centro Medico Teknon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Exposure group
In this group the treatment applied for postoperative pain involves Free-opioid anesthesia (LKDi).
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Control group
In this group the treatment applied for postoperative pain involves an opioid-based anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Age
Time Frame: Baseline
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Patient's age when the surgery was performed (in years)
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Baseline
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Sex
Time Frame: Baseline
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Patient sex classified in two groups: female (1) and male (2)
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Baseline
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PO Analgesia
Time Frame: Baseline
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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. |
Baseline
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Preoperative EVA
Time Frame: Baseline
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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. |
Baseline
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Preoperative Opioids
Time Frame: Baseline
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The preoperative opioids is a categorical variable that indicates if the patient took opioids before the surgery. There are 4 options:
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Baseline
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Postoperative EVA 1
Time Frame: 1 day after surgery
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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. |
1 day after surgery
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Postoperative EVA 2
Time Frame: 2 days after surgery
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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. |
2 days after surgery
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Postoperative EVA 4
Time Frame: 4 days after surgery
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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. |
4 days after surgery
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Postoperative EVA 6
Time Frame: 6 days after surgery
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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. |
6 days after surgery
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Sufentanil doses 1
Time Frame: From surgery release till first day of hospitalization
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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:
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From surgery release till first day of hospitalization
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Sufentanil doses 2
Time Frame: From first day of hospitalization till second day of hospitalization
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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:
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From first day of hospitalization till second day of hospitalization
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Sufentanil doses 4
Time Frame: From second day of hospitalization till fourth day of hospitalization
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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:
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From second day of hospitalization till fourth day of hospitalization
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Sufentanil doses 6
Time Frame: From fourth day of hospitalization till sixth day of hospitalization
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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:
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From fourth day of hospitalization till sixth day of hospitalization
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Rescue Methadone
Time Frame: Baseline
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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:
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Baseline
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Morphine dosage 1
Time Frame: From surgery release till first day of hospitalization
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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:
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From surgery release till first day of hospitalization
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Morphine dosage 2
Time Frame: From first day of hospitalization till second day of hospitalization
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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:
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From first day of hospitalization till second day of hospitalization
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Morphine dosage 4
Time Frame: From second day of hospitalization till fourth day of hospitalization
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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:
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From second day of hospitalization till fourth day of hospitalization
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Morphine dosage 6
Time Frame: From fourth day of hospitalization till sixth day of hospitalization
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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:
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From fourth day of hospitalization till sixth day of hospitalization
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Nausea and vomiting
Time Frame: Baseline
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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).
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Baseline
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Intestinal ileus
Time Frame: Baseline
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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).
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Baseline
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Constipation
Time Frame: Baseline
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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).
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Baseline
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Anxiolytic rescue agent
Time Frame: Baseline
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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:
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Baseline
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Oral ketamine
Time Frame: Baseline
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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).
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Baseline
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Chronic opioid and hospital discharge
Time Frame: Up to 6 days
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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:
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Up to 6 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Rafael Ramirez Paesano, MD, Servei d'Anestesiologia Centro Médico Teknon
Publications and helpful links
General Publications
- Lee 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.
- Frauenknecht 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.
- 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.
- Henderson 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.
- Scheper 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.
- Kim 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.
- Soffin 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.
- Maheshwari 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.
- Dunn 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Disease
- Congenital Abnormalities
- Hematologic Diseases
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Hemostatic Disorders
- Skin Diseases, Genetic
- Skin Abnormalities
- Collagen Diseases
- Syndrome
- Joint Instability
- Ehlers-Danlos Syndrome
Other Study ID Numbers
- OPIOIDANALGESIA1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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