RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY

NCT ID: NCT01825993

Last Updated: 2013-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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Conditions

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Sigmoidal Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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PCA endovenous

1mg/10 min Morphine

Group Type EXPERIMENTAL

MORPHINE

Intervention Type DRUG

PERIDURAL CATHETER

Peridural L-bupivacaine 0.25%

Group Type ACTIVE_COMPARATOR

L-BUPIVACAINE ; MORPHINE

Intervention Type DRUG

TANSABDOMINAL BLOCK (TAP)

L-BUPIVACAINE im

Group Type ACTIVE_COMPARATOR

L-BUPIVACAINE ; MORPHINE

Intervention Type DRUG

Interventions

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L-BUPIVACAINE ; MORPHINE

Intervention Type DRUG

MORPHINE

Intervention Type DRUG

Other Intervention Names

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PERIDURAL L-BUPIVACAINE PCA MORPHINE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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LAURA MORA LOPEZ

General Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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PUJOL GEMMA, MD

Role: PRINCIPAL_INVESTIGATOR

Corporacion Parc Tauli

Locations

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Corporacion Parc Tauli

Sabadell, Sabadell-Barcelona, Spain

Site Status

Corporacion Parc Tauli

Sabadell, Sabadell-barcelona, Spain

Site Status

Countries

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Spain

Central Contacts

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MORA L. LAURA, MD

Role: CONTACT

34937231010 ext. 21490

Facility Contacts

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Mora L Laura, MD

Role: primary

34 937231010 ext. 24190

MORA L LAURA, MD

Role: primary

34937231010 ext. 21490

mora

Role: backup

Other Identifiers

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2013-000556-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIR TAP 2013

Identifier Type: -

Identifier Source: org_study_id

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