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Trial record 14 of 149 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

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

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ClinicalTrials.gov Identifier: NCT03941899
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Emiliano Petrucci, San Salvatore Hospital of L'Aquila

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Other: Levobupivacaine in QLB II Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Simon's Two-Stage single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Analgesic Effect of Qudratus Lomborum Block II Type After Robotic-Assisted Laparoscopic Radical Prostatectomy.
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : May 6, 2021

Arm Intervention/treatment
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 Name: Quadratus Lomborum Block II type




Primary Outcome Measures :
  1. Analgesia [ Time Frame: The first 24 hours from surgery ]
    Pain assessment by using Numeric Rate Scale for pain


Secondary Outcome Measures :
  1. Opioids [ Time Frame: The first 24 hours from surgery ]
    The opioids requirement (mg of equianalgesic morphine) will be assessed

  2. Postoperative Nausea and Vomiting [ Time Frame: The first 24 hours from surgery ]
    The postoperative nausea and vomiting will be assessed

  3. Bowel function [ Time Frame: The first 24 hours from surgery ]
    The recovery of bowel function will be assessed

  4. Length of stay [ Time Frame: Day after surgery ]
    The length of stay after surgery will be assessed



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients undergoing to robotic-assisted laparoscopic radical prostatectomy
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03941899


Contacts
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Contact: Emiliano Petrucci, MD +39 0862 3681 petrucciemiliano@gmail.com
Contact: Piefrancesco Fusco, MD +39 0862 3681 pierfrancescofusco@gmail.com

Locations
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Italy
San Salvatore Academic Hospital Recruiting
Coppito, L'Aquila, Italy, 67100
Contact: Pierfrancesco Fusco, MD    +39 0862 368647    protocollogenerale@pec.asl1abruzzo.it   
Contact: Franco Marinangeli, MD    +39 0862 368648    fmarinangeli@asl1abruzzo.it   
Sub-Investigator: Petrucci Emiliano, MD         
Sub-Investigator: Scimia Paolo, MD         
Sub-Investigator: Di Carlo Stefano, MD         
Sub-Investigator: De Sanctis Francesca, MD         
Sub-Investigator: Vincenza Cofini, MD         
Sub-Investigator: Stefano Necozione         
Sponsors and Collaborators
San Salvatore Hospital of L'Aquila
Investigators
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Study Chair: Franco Marinangeli, MD San Salvatore Academic Hospital

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Responsible Party: Emiliano Petrucci, Principal Investigator, San Salvatore Hospital of L'Aquila
ClinicalTrials.gov Identifier: NCT03941899     History of Changes
Other Study ID Numbers: 0081052
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Emiliano Petrucci, San Salvatore Hospital of L'Aquila:
Pain, radical prostatectomy, QLB II type

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Levobupivacaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants