NCT04024683

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

July 15, 2019

Last Update Submit

July 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • consumption of morphine equivalence

    24 hours

Secondary Outcomes (4)

  • intraoperative remifentanil consumption,

    48 hours

  • visual analogue scale

    48 hours

  • morphine consumption

    48 hours

  • intraoperative complications

    Day 5

Study Arms (2)

Serratus block group

Realization of a serratus block and para-vertebral catheter

Procedure: Serratus block with ropivacaine 2mg/ml

Control group

Realization of a para-vertebral catheter

Interventions

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

Serratus block group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with thoracic surgery in the operating theater of Dijon University Hospital

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 18, 2019

Study Start

March 1, 2018

Primary Completion

November 1, 2018

Study Completion

June 1, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations