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临床试验/NCT04437589
NCT04437589已完成不适用

Opioid-Free Intravenous Anesthesia for Patients With Joint Hypermobility Syndrome Undergoing Craneo-Cervical Fixation: A Case-series Study Focused on Anti-hyperalgesic Approach

Servei Central d' Anestesiologia1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Age

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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).

排除标准

  • •CCF to stabilized post-traumatic or oncologic CCI.
  • •Lidocaine allergy.
  • •Advances heart-block.
  • •Epilepsy or convulsive syndrome non-medicated.

结局指标

主要结局

Age

时间窗: Baseline

Patient's age when the surgery was performed (in years)

Sex

时间窗: Baseline

Patient sex classified in two groups: female (1) and male (2)

Sufentanil doses 6

时间窗: 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)

Nausea and vomiting

时间窗: 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).

PO Analgesia

时间窗: 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.

Postoperative EVA 1

时间窗: 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 6

时间窗: 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 2

时间窗: 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

时间窗: 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)

Preoperative EVA

时间窗: 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

时间窗: 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 2

时间窗: 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

时间窗: 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.

Sufentanil doses 1

时间窗: 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)

Morphine dosage 6

时间窗: 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

Constipation

时间窗: 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).

Oral ketamine

时间窗: 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).

Rescue Methadone

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

Intestinal ileus

时间窗: 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).

Anxiolytic rescue agent

时间窗: 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

Chronic opioid and hospital discharge

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Servei Central d' Anestesiologia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Ramirez Paesano

Principal Investigator

Servei Central d' Anestesiologia

研究点 (1)

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