The Analgesic Effect of QLB II After Robotic Prostatectomy. (QLB II: Quadratus Lomborum Block II Type) (QLBII)

May 1, 2021 updated by: Emiliano Petrucci, San Salvatore Hospital of L'Aquila

The Analgesic Effect of Qudratus Lomborum Block II Type After Robotic-Assisted Laparoscopic Radical Prostatectomy.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Quadratus Lomborum Block II type will be performed before performing robotic-assisted laparoscopic radical prostatectomy.

The post-operative analgesic effect will be assessed, by using Numeric Rate Scale for pain.

The pain assessment will be evaluated during the first 24 hours from surgery. The opioids requirement and side effects will be also assessed.

Study Type

Interventional

Enrollment (Actual)

48

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
    • L'Aquila
      • Coppito, L'Aquila, Italy, 67100
        • San Salvatore Academic Hospital

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: QLB II
Quadratus Lomborum Blocck II type will be performed before robot-assisted laparoscopic radical prostatectomy
Other: Levobupivacaine in QLB II
Quadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle.
Other Names:
  • Quadratus Lomborum Block II type

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia
Time Frame: The first 24 hours from surgery
Pain assessment by using Numeric Rate Scale for pain
The first 24 hours from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids
Time Frame: The first 24 hours from surgery
The opioids requirement (mg of equianalgesic morphine) will be assessed
The first 24 hours from surgery
Postoperative Nausea and Vomiting
Time Frame: The first 24 hours from surgery
The postoperative nausea and vomiting will be assessed
The first 24 hours from surgery
Bowel function
Time Frame: The first 24 hours from surgery
The recovery of bowel function will be assessed
The first 24 hours from surgery
Length of stay
Time Frame: Day after surgery
The length of stay after surgery will be assessed
Day after surgery

Collaborators and Investigators

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

Sponsor

San Salvatore Hospital of L'Aquila

Investigators

  • Study Chair: Franco Marinangeli, MD, San Salvatore Academic Hospital

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 (Actual)

May 6, 2019

Primary Completion (Actual)

December 6, 2020

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0081052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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