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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04024683
Other study ID # Bouhemad - BEAL 2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date June 1, 2019

Study information

Verified date July 2019
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date June 1, 2019
Est. primary completion date November 1, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
Serratus block with ropivacaine 2mg/ml
The serratus block was made using a 50 mm needle with ultrasound guidance. It was performed supine, the ultrasound probe identifying the 3, 4 or 5th intercostal space and then the needle was introduced under ultrasound control

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary consumption of morphine equivalence 24 hours
Secondary intraoperative remifentanil consumption, 48 hours
Secondary visual analogue scale 48 hours
Secondary morphine consumption 48 hours
Secondary intraoperative complications Day 5
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