NCT03941899

Brief Summary

The analgesic effects of Quadratus Lomborum Block II type after robotic-assisted laparoscopic radical prostatectomy, will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable postoperative-pain

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

First Submitted

Initial submission to the registry

May 6, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

May 6, 2019

Last Update Submit

May 1, 2021

Conditions

Postoperative Pain

Keywords

Pain, radical prostatectomy, QLB II type

Outcome Measures

Primary Outcomes (1)

  • Analgesia

    Pain assessment by using Numeric Rate Scale for pain

    The first 24 hours from surgery

Secondary Outcomes (4)

  • Opioids

    The first 24 hours from surgery

  • Postoperative Nausea and Vomiting

    The first 24 hours from surgery

  • Bowel function

    The first 24 hours from surgery

  • Length of stay

    Day after surgery

Study Arms (1)

QLB II

OTHER

Quadratus Lomborum Blocck II type will be performed before robot-assisted laparoscopic radical prostatectomy

Other: Levobupivacaine in QLB II

Interventions

Levobupivacaine in QLB IIOTHER

Quadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle.

Also known as: Quadratus Lomborum Block II type
QLB II

Eligibility Criteria

Age18 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsPatients undergoing to robotic-assisted laparoscopic radical prostatectomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist status I-III
  • Written informed consent

You may not qualify if:

  • Body mass Index \> 35 kg/m2
  • Allergies to local anesthetics
  • primaries or secondaries coagulopathies
  • addiction to drugs
  • severe kidney and liver diseases
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Salvatore Academic Hospital

Coppito, L'Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Franco Marinangeli, MD

    San Salvatore Academic Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Simon's Two-Stage single arm study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 8, 2019

Study Start

May 6, 2019

Primary Completion

December 6, 2020

Study Completion

April 30, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)