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

Completed

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

• Registration Number: NCT04538235
• Lead Sponsor: University Hospital, Montpellier

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-20
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Study First Posted: 2020-09-04
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bi-block (Serratus and erector spinae block) group	Thoracic Regional Analgesia	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 Epidural Analgesia (TEA) group	Thoracic Regional Analgesia	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.

Primary Outcome Measures

Name	Time	Method
cumulative morphine consumption on postoperative day 2	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.

Secondary Outcome Measures

Name	Time	Method
hypotension	up to postoperative day 2
non-opioid analgesics consumption on postoperative day 2	postoperative day 2	Paracetamol, Tramadol, Ketoprofen, Nefopam cumulative consumption on POD 2.
Pain assessed by visual analog pain scale (VAS)	up to postoperative day 2	mean VAS, maximal VAS, number of events with a VAS \> 3
Urinary retention	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

Trial Locations

Locations (1)

Intensive Care Unit, D - University hospital of Montpellier; 🇫🇷 Montpellier, France