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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02460640
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ester Forastiere, Regina Elena Cancer Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Pain Chronic Pain Procedure: Tap block Procedure: intravenous Patient controlled analgesia Drug: Morphine Drug: Ropivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Ultrasound-guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy. A Prospective, Randomized, Clinical Trial
Study Start Date : May 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017


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
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

Drug: Morphine
Drug: Ropivacaine
Active Comparator: No Tap Block
the patients who not receive tap block but they will be as intervention intravenous Patient controlled analgesia
Procedure: intravenous Patient controlled analgesia
intravenous patient-controlled analgesia with morphine

Drug: Morphine



Primary Outcome Measures :
  1. Morphine consuption 24 hr after surgery [ Time Frame: 24 hours ]
    Cumulative morphine consuption (mg) 24 hr starting from the time of extubation.

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460640


Locations
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Italy
Regina Elena CI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ester Forastiere, Head of Anestesiology and Critical Care Department, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier: NCT02460640    
Other Study ID Numbers: Tap Block
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: January 2018
Keywords provided by Ester Forastiere, Regina Elena Cancer Institute:
Minimally invasive surgery
Partial nephrectomy
Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics