Clinical trial NCT04147754: Erector Spinae Block, Epidural Analgesia and Intrathecal Analgesia in Thoracic Surgery
Official title: Efficacités comparées du Bloc Des Muscles érecteurs du Rachis, du Bloc péridural et de la rachianalgésie en Chirurgie Thoracique Majeure.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing thoracic surgery for pulmonary resection in the University Hospital of Angers, in France.

Brief summary: Pulmonary thoracic surgery is often responsible for severe postoperative pain, which is associated with an increase in postoperative morbidity and mortality. Moreover, postoperative thoracic pain has a strong impact on patient rehabilitation and is associated with an increase in hospital stay.

Various analgesic techniques allow effective management of pain in the context of thoracic surgery. Regional anesthesia, particularly, allows a powerful analgesia, and limits the use of opioids and their side effects. Among regional anesthesia techniques, thoracic epidural analgesia has become the gold standard for post-thoracotomy analgesia. However, it induces a sympathetic block that promotes in particular per and postoperative hypotension and acute urinary retentions. Thus, new regional anesthesia techniques have been developed and assessed in thoracic surgery in order to avoid side effects related to epidural analgesia, particularly paravertebral block and erector spinae block, but also intrathecal analgesia. Paravertebral block has shown analgesic efficacy after thoracic surgery, and its interest in reducing the risk of hypotension, acute urinary retention, pruritus and postoperative nausea and vomiting compared with the epidural analgesia. Erector spinae block, recently described and evaluated in this context of thoracic surgery, seems to have the same interests and to be easier to achieve than the paravertebral block, but has been little studied. Finally, intrathecal morphine is frequently used because of an easy and rapid realization, and because it allows an adequate analgesia and the reduction of the duration of stay in intensive care compared to the epidural one. However, despite its frequent use, very few studies have compared intrathecal anesthesia with the epidural and other peri-spinal blocks.

These three types of analgesia, epidural analgesia, intrathecal morphine, and erector spinae block are regional anesthesia methods regularly used for pulmonary surgery in the department of the investigators. All of these techniques have shown their analgesic efficacy, but each seems to have particular respective interests, in terms of achievement, management, or perioperative rehabilitation. The objective of the investigators study is to evaluate the effectiveness of each of its techniques to treat postoperative pain and improve the rehabilitation of these patients.


Eligibility criteria: Inclusion Criteria:

* Thoracic surgery for pulmonary resection
* Scheduled regional anesthesia: epidural anesthesia, intrathecal morphine or erector spinae block

Exclusion Criteria:

* No epidural anesthesia or no intrathecal morphine or no erector spinae block performed

Primary outcomes:
measure: Pain assessment at H+48
timeFrame: Day 2 after surgery
Secondary outcomes:
measure: Total consumption of morphine (per and postoperative)
timeFrame: Hour 2, Day 1, Day 2 and Day 3 after surgery.
measure: Length of stay in intensive care unit
timeFrame: Through study completion, an average of 1 year
measure: Length of hospital stay
timeFrame: Through study completion, an average of 1 year
measure: Impact on respiratory function
timeFrame: Day 1, Day 2 and Day 3 after surgery.
measure: Frequency of adverse effects related to morphine Frequency of morphine side effects
timeFrame: Hour 2, Day 1, Day 2 and Day 3 after surgery.
measure: Postoperative pain assessment at other times
timeFrame: Hour 2, Day 1, and Day 3 after surgery.
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION
Study officials:
affiliation: University Hospital of Angers, France
name: Emmanuel Rineau, MD
role: PRINCIPAL_INVESTIGATOR
References: