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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Surgery
• Intervention / Treatment: Procedure: Epidural anesthesia; Procedure: Intrathecal morphine; Procedure: Erector spinae block

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing thoracic surgery for pulmonary resection in the University Hospital of Angers, in France.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epidural anesthesia; At physician discretion (observational study)	Procedure: Epidural anesthesia; Preoperative epidural anesthesia at physician discretion
Intrathecal morphine; At physician discretion (observational study)	Procedure: Intrathecal morphine; Preoperative intrathecal morphine at physician discretion
Erector spinae block; At physician discretion (observational study)	Procedure: Erector spinae block; Preoperative erector spinae block at physician discretion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Peak Flow in L/min	Day 1, Day 2 and Day 3 after surgery.
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	Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)	Hour 2, Day 1, and Day 3 after surgery.

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Anticipated): November 4, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 2019/97

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No