NCT02055664

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2015

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

February 4, 2014

Last Update Submit

May 3, 2019

Conditions

Elective Surgery of the Spine by Laparotomy

Outcome Measures

Primary Outcomes (1)

  • Consumption of morphine in mg

    First 48 hours following the surgery

Secondary Outcomes (1)

  • Intensity of pain

    First 48 hours following the surgery

Study Arms (2)

treatment

EXPERIMENTAL
Drug: Chlorure de sodium 0.9%

control

PLACEBO COMPARATOR
Drug: Ropivacaine 0.2%

Interventions

Ropivacaine 0.2%DRUG
control
Chlorure de sodium 0.9%DRUG
treatment

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 5, 2014

Study Start

January 23, 2014

Primary Completion

August 12, 2015

Last Updated

May 6, 2019

Record last verified: 2019-05

Locations

FR(1)