The Effects of TAP Block on Postsurgical Pain After Minimally Invasive Partial Nephrectomy:

January 31, 2018 updated by: Ester Forastiere, Regina Elena Cancer Institute

The Effects of Ultrasound-guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy. A Prospective, Randomized, Clinical Trial

Single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

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

  • Italy
      • Rome, Italy, 00144
        • Regina Elena CI

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • asa score I,II,II
  • patients scheduled for robot assisted partial nephrectomy

Exclusion Criteria:

  • previous abdominal surgery
  • inability to provide informed consent
  • allergy to the anesthetic drugs

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tap Block
the intervention will be tap block after induction of anesthesia with ropivacaine 0,5% 15ml and continuous patient-controlled analgesia with morphine
Drug: Morphine
Drug: Ropivacaine
Procedure: Tap block
intravenous patient-controlled analgesia with morphine and tap block with subcostal and posterior approach with ropivacaine 0,5% 15ml+15ml
Procedure: intravenous Patient controlled analgesia
intravenous patient-controlled analgesia with morphine
ACTIVE_COMPARATOR: No Tap Block
the patients who not receive tap block but they will be as intervention intravenous Patient controlled analgesia
Drug: Morphine
Procedure: intravenous Patient controlled analgesia
intravenous patient-controlled analgesia with morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consuption 24 hr after surgery
Time Frame: 24 hours
Cumulative morphine consuption (mg) 24 hr starting from the time of extubation.
24 hours
Acute pain after surgery measured with Numerical Rating Scale
Time Frame: 24 hours
patients were assessed for pain, according to Numerical Rating Scale (NRS; 0: no pain to 10: worst pain imaginable)
24 hours

Collaborators and Investigators

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

Sponsor

Regina Elena Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (ACTUAL)

August 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (ESTIMATE)

June 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAP Block

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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