Erector Spinae Block, Epidural Analgesia and Intrathecal Analgesia in Thoracic Surgery

NCT04147754 — Unknown, 200 participants, University Hospital, Angers

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Efficacités comparées du Bloc Des Muscles érecteurs du Rachis, du Bloc péridural et de la rachianalgésie en Chirurgie Thoracique Majeure.

RegistryNCT04147754, acronym SPIRIT
StatusUnknown
Study typeObservational
Enrollment200 (Estimated)
SponsorUniversity Hospital, Angers (Other gov)
ConditionsPulmonary Surgery
InterventionsEpidural anesthesia, Intrathecal morphine, Erector spinae block (Procedure)
Datesstart 2019-11-04 (estimated), primary completion 2020-11-01 (estimated), completion 2021-02-01 (estimated), first posted 2019-11-01, last updated 2019-11-01
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Pulmonary Surgery All trials of Epidural anesthesia All trials of Intrathecal morphine

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Epidural anesthesiaProcedure: Epidural anesthesiaAt physician discretion (observational study)
Intrathecal morphineProcedure: Intrathecal morphineAt physician discretion (observational study)
Erector spinae blockProcedure: Erector spinae blockAt physician discretion (observational study)
  • Epidural anesthesia (Procedure): Preoperative epidural anesthesia at physician discretion
  • Intrathecal morphine (Procedure): Preoperative intrathecal morphine at physician discretion
  • Erector spinae block (Procedure): Preoperative erector spinae block at physician discretion

+Outcome measures

Primary outcomes

  • Pain assessment at H+48 [Day 2 after surgery]: Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)

Secondary outcomes

  • Total consumption of morphine (per and postoperative) [Hour 2, Day 1, Day 2 and Day 3 after surgery.]
  • Length of stay in intensive care unit [Through study completion, an average of 1 year]
  • Length of hospital stay [Through study completion, an average of 1 year]
  • Impact on respiratory function [Day 1, Day 2 and Day 3 after surgery.]: Peak Flow in L/min
  • Frequency of adverse effects related to morphine Frequency of morphine side effects [Hour 2, Day 1, Day 2 and Day 3 after surgery.]
  • Postoperative pain assessment at other times [Hour 2, Day 1, and Day 3 after surgery.]: Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATIONAngersFrance

+Investigators