The Effect of the Ultrasound-guided Serratus Anterior Plane Block in Combinaison With Thoracic Paravertebral cathéter Versus Thoracic Paravertebral Cather for Perioperative Analgesia in Thoracic Surgery

Completed

• Conditions: Thoracic Surgery
• Interventions: Procedure: Serratus block with ropivacaine 2mg/ml

• Registration Number: NCT04024683
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Introduction

The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. The objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery.

Materials and methods

We retrospectively included 159 ASA I-III major patients who underwent scheduled thoracic surgery in the operating theater of Dijon University Hospital, between March and November 2018. All patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. They were included in two groups: deep serrate deep group (GS) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% Ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (GC) benefiting from a paravertebral catheter alone. The primary endpoint was 24-hour morphine equivalent consumption. The criteria for secondary judgments were intraoperative remifentanil consumption, VAS at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. The morphine equivalent was calculated according to an equivalence table with reference to Oxycodone per os. Quantitative data are presented in median and standard deviation and were compared by Student's t-test or Wilcoxon test.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-11-01
• Study Completion: 2019-06-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-16
• Last Update Submitted: 2019-07-16
• Study First Posted: 2019-07-18
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• We included all patients over the age of 18 who met the classification criteria of the American Society of Anesthesiology (ASA) and had thoracic surgery in the operating theater of Dijon University Hospital

Exclusion Criteria

• Exclusion criteria were ASA 4 or higher, pregnant or breastfeeding women, minor patients, patients not able to use morphine PCA, and patients with chronic algia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Serratus block group	Serratus block with ropivacaine 2mg/ml	Realization of a serratus block and para-vertebral catheter

Primary Outcome Measures

Name	Time	Method
consumption of morphine equivalence	24 hours

Secondary Outcome Measures

Name	Time	Method
intraoperative remifentanil consumption,	48 hours
visual analogue scale	48 hours
morphine consumption	48 hours
intraoperative complications	Day 5

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France