NCT02389361

Brief Summary

Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_4 pain

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

April 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 13, 2015

Completed
Last Updated

August 21, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

February 27, 2015

Results QC Date

June 22, 2015

Last Update Submit

July 24, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Acute Pain

    Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS \> 4. The VAS use units on a scale.

    In recovery room

Study Arms (2)

Group Z

EXPERIMENTAL

Postoperative Analgesia with Zaldiar

Drug: Zaldiar

Group PT

ACTIVE COMPARATOR

Postoperative Analgesia with Paracetamol-Tramadol

Drug: Paracetamol-Tramadol

Interventions

ZaldiarDRUG

Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)

Also known as: Oral Zaldiar
Group Z
Paracetamol-TramadolDRUG

Postoperative analgesia with intravenous Paracetamol and Tramadol

Also known as: Intravenous Paracetamol and Tramadol
Group PT

Eligibility Criteria

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

You may qualify if:

  • All patients incoming for inguinal hernia repair

You may not qualify if:

  • Preoperative abuse of analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Results Point of Contact

Title
Dr. DEFLANDRE Eric
Organization
ASTES
eric.deflandre@gmail.com
0032477764241

Study Officials

  • Eric Deflandre

    Astes

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eric DEFLANDRE, MD, FCCP

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 17, 2015

Study Start

April 1, 2011

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

August 21, 2018

Results First Posted

August 13, 2015

Record last verified: 2018-07