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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Age | Patient's age when the surgery was performed (in years) | Baseline |
| Sex | Patient sex classified in two groups: female (1) and male (2) | 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. | 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. | Baseline |
| Preoperative Opioids | The preoperative opioids is a categorical variable that indicates if the patient took opioids before the surgery. There are 4 options:
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Rafael Ramirez Paesano, MD | Servei d'Anestesiologia Centro Médico Teknon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Teknon | Barcelona | 08022 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25655119 | Background | 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. | |
| 30627832 | Background | 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. |
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| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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| 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. | 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. | 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. | 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 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 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 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 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:
| 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:
| 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:
| 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:
| 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:
| 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). | 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). | 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). | 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:
| 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). | 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:
| Up to 6 days |
| 26316810 | Background | 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. |
| 21412369 | Background | 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. |
| 29225750 | Background | 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. |
| 30933925 | Background | 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. |
| 32235144 | Background | 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. |
| 27036605 | Background | 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. |
| 30802933 | Background | 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |