RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY (2013/004)

April 5, 2013 updated by: LAURA MORA LOPEZ, Corporacion Parc Tauli

RANDOMISED STUDY ABOUT POTSOTERATORY PAIN CONTROL IN LAPAROSCOPIC SIGMOIDECTOMY

The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Sabadell-Barcelona
      • Sabadell, Sabadell-Barcelona, Spain, 08208
        • Corporacion Parc Tauli
    • Sabadell-barcelona
      • Sabadell, Sabadell-barcelona, Spain, 08208
        • Corporacion Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age more than 18
  • Laparoscopic sigmoidectomy
  • Informed consent firmed

Exclusion Criteria:

  • ASA IV
  • Urgent surgery
  • Sigmoid tumour stage IV
  • Cronic pain treatment
  • No informed consent firmed
  • Paliative surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PCA endovenous
1mg/10 min Morphine
Drug: MORPHINE
Active Comparator: PERIDURAL CATHETER
Peridural L-bupivacaine 0.25%
Drug: L-BUPIVACAINE ; MORPHINE
Other Names:
  • PERIDURAL L-BUPIVACAINE
  • PCA MORPHINE
Active Comparator: TANSABDOMINAL BLOCK (TAP)
L-BUPIVACAINE im
Drug: L-BUPIVACAINE ; MORPHINE
Other Names:
  • PERIDURAL L-BUPIVACAINE
  • PCA MORPHINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EVA (POSTOPERATIVE PAIN)
Time Frame: 72 H POSTOPERATIVE
The investigators asked the patient the postoperative pain during teh first 72 hours by EVA scale.
72 H POSTOPERATIVE

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADVERSE EFFECTS
Time Frame: five days
the investigators look for adverse effects
five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: PUJOL GEMMA, MD, Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR TAP 2013
  • 2013-000556-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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