NCT02460640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

May 19, 2015

Last Update Submit

January 31, 2018

Conditions

Acute PainChronic Pain

Keywords

Minimally invasive surgeryPartial nephrectomy

Outcome Measures

Primary Outcomes (2)

  • Morphine consuption 24 hr after surgery

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

    24 hours

  • 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)

    24 hours

Study Arms (2)

Tap Block

ACTIVE COMPARATOR

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

Procedure: Tap blockProcedure: intravenous Patient controlled analgesiaDrug: MorphineDrug: Ropivacaine

No Tap Block

ACTIVE COMPARATOR

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

Procedure: intravenous Patient controlled analgesiaDrug: Morphine

Interventions

Tap blockPROCEDURE

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

Tap Block
intravenous Patient controlled analgesiaPROCEDURE

intravenous patient-controlled analgesia with morphine

No Tap BlockTap Block
MorphineDRUG
No Tap BlockTap Block
RopivacaineDRUG
Tap Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Elena CI

Rome, 00144, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31504875DERIVED

MeSH Terms

Conditions

Acute PainChronic Pain

Interventions

Analgesia, Patient-ControlledMorphineRopivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and AnalgesiaMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anestesiology and Critical Care Department

Study Record Dates

First Submitted

May 19, 2015

First Posted

June 2, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

IT(1)