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

NCT04147754 | Unknown

• 1 other identifier: 2019/97
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Surgery

Outcome Measures

Primary Outcomes (1)

• Pain assessment at H+48

  Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)

  Day 2 after surgery

Secondary Outcomes (6)

• 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.

• Frequency of adverse effects related to morphine Frequency of morphine side effects

  Hour 2, Day 1, Day 2 and Day 3 after surgery.

Study Arms (3)

Epidural anesthesia

At physician discretion (observational study)

Procedure: Epidural anesthesia

Intrathecal morphine

At physician discretion (observational study)

Procedure: Intrathecal morphine

Erector spinae block

At physician discretion (observational study)

Procedure: Erector spinae block

Interventions

Epidural anesthesia PROCEDURE

Preoperative epidural anesthesia at physician discretion

Epidural anesthesia

Intrathecal morphine PROCEDURE

Preoperative intrathecal morphine at physician discretion

Intrathecal morphine

Erector spinae block PROCEDURE

Preoperative erector spinae block at physician discretion

Erector spinae block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Thoracic surgery for pulmonary resection
• Scheduled regional anesthesia: epidural anesthesia, intrathecal morphine or erector spinae block

You may not qualify if:

• No epidural anesthesia or no intrathecal morphine or no erector spinae block performed

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION

Angers, 49100, France

Location

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Emmanuel Rineau, MD

  University Hospital of Angers, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Rineau, MD

CONTACT

+33241353951; erineau@live.fr

Laurent Beydon, MD PHD

CONTACT

+33241353951

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 1, 2019
• Study Start: November 4, 2019
• Primary Completion: November 1, 2020
• Study Completion: February 1, 2021
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

FR (1)