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Erector Spinae Block, Epidural Analgesia and Intrathecal Analgesia in Thoracic Surgery (SPIRIT)

U

University Hospital, Angers

Status

Unknown

Conditions

Pulmonary Surgery

Treatments

Procedure: Erector spinae block
Procedure: Epidural anesthesia
Procedure: Intrathecal morphine

Study type

Observational

Funder types

Other

Identifiers

NCT04147754
2019/97

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

Epidural anesthesia
Description:
At physician discretion (observational study)
Treatment:
Procedure: Epidural anesthesia
Intrathecal morphine
Description:
At physician discretion (observational study)
Treatment:
Procedure: Intrathecal morphine
Erector spinae block
Description:
At physician discretion (observational study)
Treatment:
Procedure: Erector spinae block

Trial contacts and locations

1

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Central trial contact

Emmanuel Rineau, MD; Laurent Beydon, MD PHD

Data sourced from clinicaltrials.gov

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