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

Primary Purpose

Acute Pain, Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Tap block

intravenous Patient controlled analgesia

Morphine

Ropivacaine

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Minimally invasive surgery, Partial nephrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Regina Elena CI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tap Block

No Tap Block

Arm Description

the intervention will be tap block after induction of anesthesia with ropivacaine 0,5% 15ml and continuous patient-controlled analgesia with morphine

the patients who not receive tap block but they will be as intervention intravenous Patient controlled analgesia

Outcomes

Primary Outcome Measures

Morphine consuption 24 hr after surgery

Cumulative morphine consuption (mg) 24 hr starting from the time of extubation.

Acute pain after surgery measured with Numerical Rating Scale

patients were assessed for pain, according to Numerical Rating Scale (NRS; 0: no pain to 10: worst pain imaginable)

Secondary Outcome Measures

Full Information

NCT ID

NCT02460640

First Posted

May 19, 2015

Last Updated

January 31, 2018

Sponsor

Regina Elena Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT02460640

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Regina Elena Cancer Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain, Chronic Pain

Keywords

Minimally invasive surgery, Partial nephrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tap Block

Arm Type

Active Comparator

Arm Description

the intervention will be tap block after induction of anesthesia with ropivacaine 0,5% 15ml and continuous patient-controlled analgesia with morphine

Arm Title

No Tap Block

Arm Type

Active Comparator

Arm Description

the patients who not receive tap block but they will be as intervention intravenous Patient controlled analgesia

Intervention Type

Procedure

Intervention Name(s)

Tap block

Intervention Description

intravenous patient-controlled analgesia with morphine and tap block with subcostal and posterior approach with ropivacaine 0,5% 15ml+15ml

Intervention Type

Procedure

Intervention Name(s)

intravenous Patient controlled analgesia

Intervention Description

intravenous patient-controlled analgesia with morphine

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Primary Outcome Measure Information:

Title

Morphine consuption 24 hr after surgery

Description

Cumulative morphine consuption (mg) 24 hr starting from the time of extubation.

Time Frame

24 hours

Title

Acute pain after surgery measured with Numerical Rating Scale

Description

patients were assessed for pain, according to Numerical Rating Scale (NRS; 0: no pain to 10: worst pain imaginable)

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Regina Elena CI

City

Rome

ZIP/Postal Code

00144

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

31504875

Citation

Covotta M, Claroni C, Costantini M, Torregiani G, Pelagalli L, Zinilli A, Forastiere E. The Effects of Ultrasound-Guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy: A Prospective Randomized Clinical Trial. Pain Med. 2020 Feb 1;21(2):378-386. doi: 10.1093/pm/pnz214.

Results Reference

derived

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

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