Pulmonary Surgery Clinical Trial
— SPIRITOfficial title:
Efficacités comparées du Bloc Des Muscles érecteurs du Rachis, du Bloc péridural et de la rachianalgésie en Chirurgie Thoracique Majeure.
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | February 2021 |
Est. primary completion date | November 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain assessment at H+48 | Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain) | Day 2 after surgery | |
Secondary | Total consumption of morphine (per and postoperative) | Hour 2, Day 1, Day 2 and Day 3 after surgery. | ||
Secondary | Length of stay in intensive care unit | Through study completion, an average of 1 year | ||
Secondary | Length of hospital stay | Through study completion, an average of 1 year | ||
Secondary | Impact on respiratory function | Peak Flow in L/min | Day 1, Day 2 and Day 3 after surgery. | |
Secondary | Frequency of adverse effects related to morphine Frequency of morphine side effects | Hour 2, Day 1, Day 2 and Day 3 after surgery. | ||
Secondary | Postoperative pain assessment at other times | Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain) | Hour 2, Day 1, and Day 3 after surgery. |