The Tap Block Technique Via the Anterior Approach in Elec... | NCT02055664

Studies
The Tap Block Technique Via the Anterior Approach in Elective Surgery of the Spine

NCT02055664

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

May 6, 2019Actual

Enrollment

80Actual

Phase

Phase 4

Conditions

Elective Surgery of the Spine by Laparotomy

Interventions

Ropivacaine 0.2%
Chlorure de sodium 0.9%

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2014Actual

Primary Completion Date

Aug 12, 2015Actual

Completion Date

Not provided

First Submitted Date

Feb 4, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2019

Last Update Posted Date

May 6, 2019Actual

Description Module

Brief Summary

This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.

Procedure:

Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Experimental		Drug: Chlorure de sodium 0.9%
control	Placebo Comparator		Drug: Ropivacaine 0.2%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine 0.2%	Drug		control
Chlorure de sodium 0.9%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Consumption of morphine in mg		First 48 hours following the surgery

Secondary Outcomes

Measure	Description	Time Frame
Intensity of pain		First 48 hours following the surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 18 yo who have provided written informed consent
Patients with an indication for elective spinal surgery using laparotomy
Patients with national health insurance cover

Exclusion Criteria:

Adults under guardianship
Pregnant or breast-feeding women
allergies or contra-indication for paracetamol, morphine-based drugs
Contra-indication for ropivacaine
Contra-indication for sodium chloride
inability to understand PCA (patient-controlled anaesthesia)
Hypersensitivity to ropivacaine or to other aminoamide local anaesthetics
Hypovolemia

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided