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

Pulmonary Surgery Clinical Trial

— SPIRIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04147754
• Other study ID #: 2019/97
• Status: Not yet recruiting
• Start date: November 4, 2019
• Est. completion date: February 2021

Study information

• Verified date: October 2019
• Source: University Hospital, Angers
• Contact: Emmanuel Rineau, MD
• Phone: +33241353951
• Email: erineau[@]live.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2021
• Est. primary completion date: November 2020
• 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

Related Conditions & MeSH terms

• Pulmonary Surgery

Intervention

Procedure:
• Epidural anesthesia
Preoperative epidural anesthesia at physician discretion
• Intrathecal morphine
Preoperative intrathecal morphine at physician discretion
• Erector spinae block
Preoperative erector spinae block at physician discretion

Locations

Country	Name	City	State
France	CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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.