Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.

NCT ID: NCT04538235

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-20
• Study Completion Date: 2019-12-31

Brief Summary

Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS.

The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery.

Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).

Conditions

Erector Spinae Muscle Plane Block; Serratus Anterior Muscle Plane Block; Video-Assisted Thoracic Surgery; Lung Cancer; Pleural Diseases; Thoracic Epidural; Analgesia; Enhanced Recovery After Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bi-block (Serratus and erector spinae block) group

The Bi-block consisted in performing an ESP block followed by a SAP block on the side ipsilateral to the thoracic surgery. For the ESP block, 40 ml of Ropivacaine 2mg/ml were injected under the erector spinae muscle plane, at the level of the 4th thoracic vertebra. For the SAP block, 40 ml of Ropivacaine 2 mg/ml were injected under the serratus anterior muscle plane. The cumulative dose of Ropivacaine did not exceed 3 mg/kg.

Regional anesthesia was performed before surgery.

Thoracic Regional Analgesia

Intervention Type: PROCEDURE

In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.

Thoracic Epidural Analgesia (TEA) group

The thoracic epidural was performed according to a standardized protocol, with a Tuohy needle via the median puncture technique, at the level of T4-T5 intervertebral space. After a test dose of 2 to 3 ml of Lidocaine, 5 to 10 ml of a mixture of Ropivacaine 2 mg/ml and Sufentanil 0.5 µg / mL were injected. Epidural continuous administration was performed with the same mixture of anesthetic connected to a CADD Solis ™ pump set according to a PCEA protocol adapted to the patient's weight (continuous flow rate from 3 to 6 ml/h, self-administered bolus dose from 3 to 5 ml, refractory period 30 min).

Regional anesthesia was performed before surgery.

Thoracic Regional Analgesia

Intervention Type: PROCEDURE

In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.

Interventions

Thoracic Regional Analgesia

In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.

Intervention Type: PROCEDURE

Other Intervention Names

Thoracic Epidural Analgesia; Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae block

Eligibility Criteria

Inclusion Criteria

• To be over 18.
• To be scheduled for VATS in the center of the study during the study period.
• Thoracic Epidural analgesia of Bi-block analgesia.

Exclusion Criteria

• Chronic pain or opioid use before surgery (6 months).
• Postoperative hospitalization in ICU during the first two days.
• Postoperative surgical complication needing surgical revision during the first two days.
• Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Sentenac, MD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Pascal H Colson, MD, PhD

Role: STUDY_CHAIR

Montpellier University Hospital

Locations

Intensive Care Unit, D - University hospital of Montpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL19_0473

Identifier Type: -

Identifier Source: org_study_id