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

Analgesic Non Inferiority of the Thoracic Bi-block Combining an Erector Spinae Muscle Plane Block and a Serratus Anterior Muscle Plane Block in Comparison With Thoracic Epidural for Video-Assisted Thoracic Surgery.

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).

Study Overview

• Status: Completed
• Conditions: Pleural Diseases; Analgesia; Lung Cancer; Enhanced Recovery After Surgery; Thoracic Epidural; Video-Assisted Thoracic Surgery; Erector Spinae Muscle Plane Block; Serratus Anterior Muscle Plane Block
• Intervention / Treatment: Procedure: Thoracic Regional Analgesia

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Intensive Care Unit, D - University hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Each patient enrolled in the Bi-block group were matched by age, gender and type of surgery with two controls in the TEA group. Patients not-matched were secondarily excluded.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: 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.; Other Names: Thoracic Epidural Analgesia; Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae block
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.	Procedure: 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.; Other Names: Thoracic Epidural Analgesia; Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative morphine consumption on postoperative day 2	cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.	postoperative day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-opioid analgesics consumption on postoperative day 2	Paracetamol, Tramadol, Ketoprofen, Nefopam cumulative consumption on POD 2.	postoperative day 2
Pain assessed by visual analog pain scale (VAS)	mean VAS, maximal VAS, number of events with a VAS > 3	up to postoperative day 2
Urinary retention		up to postoperative day 2
hypotension		up to postoperative day 2
pleural drain duration		up to postoperative day 2
duration of hospitalization		up to postoperative day 2
occurrence of prurit		up to postoperative day 2

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pierre Sentenac, MD, Montpellier University Hospital; Study Chair: Pascal H Colson, MD, PhD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: regional anesthesia; video-assisted thoracic surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Aneurysm; Aneurysm, Dissecting; Pleural Diseases
• Other Study ID Numbers: RECHMPL19_0473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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