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

• Conditions: Pulmonary Surgery
• Interventions: Procedure: Erector spinae block; Procedure: Intrathecal morphine; Procedure: Epidural anesthesia

• Registration Number: NCT04147754
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-11-01
• Last Update Posted: 2019-11-01
• Study Start: 2019-11-04
• Primary Completion: 2020-11
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Erector spinae block	Erector spinae block	At physician discretion (observational study)
Intrathecal morphine	Intrathecal morphine	At physician discretion (observational study)
Epidural anesthesia	Epidural anesthesia	At physician discretion (observational study)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Length of stay in intensive care unit	Through study completion, an average of 1 year
Total consumption of morphine (per and postoperative)	Hour 2, Day 1, Day 2 and Day 3 after surgery.
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)

Trial Locations

Locations (1)

CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION; 🇫🇷 Angers, France