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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Levobupivacaine in QLB II
Sponsored by
San Salvatore Hospital of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, radical prostatectomy, QLB II type

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • San Salvatore Academic Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

QLB II

Arm Description

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

Outcomes

Primary Outcome Measures

Analgesia
Pain assessment by using Numeric Rate Scale for pain

Secondary Outcome Measures

Opioids
The opioids requirement (mg of equianalgesic morphine) will be assessed
Postoperative Nausea and Vomiting
The postoperative nausea and vomiting will be assessed
Bowel function
The recovery of bowel function will be assessed
Length of stay
The length of stay after surgery will be assessed

Full Information

First Posted
May 6, 2019
Last Updated
May 1, 2021
Sponsor
San Salvatore Hospital of L'Aquila
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1. Study Identification

Unique Protocol Identification Number
NCT03941899
Brief Title
The Analgesic Effect of QLB II After Robotic Prostatectomy. (QLB II: Quadratus Lomborum Block II Type)
Acronym
QLBII
Official Title
The Analgesic Effect of Qudratus Lomborum Block II Type After Robotic-Assisted Laparoscopic Radical Prostatectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
December 6, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Salvatore Hospital of L'Aquila

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pain, radical prostatectomy, QLB II type

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Simon's Two-Stage single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QLB II
Arm Type
Other
Arm Description
Quadratus Lomborum Blocck II type will be performed before robot-assisted laparoscopic radical prostatectomy
Intervention Type
Other
Intervention Name(s)
Levobupivacaine in QLB II
Other Intervention Name(s)
Quadratus Lomborum Block II type
Intervention Description
Quadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle.
Primary Outcome Measure Information:
Title
Analgesia
Description
Pain assessment by using Numeric Rate Scale for pain
Time Frame
The first 24 hours from surgery
Secondary Outcome Measure Information:
Title
Opioids
Description
The opioids requirement (mg of equianalgesic morphine) will be assessed
Time Frame
The first 24 hours from surgery
Title
Postoperative Nausea and Vomiting
Description
The postoperative nausea and vomiting will be assessed
Time Frame
The first 24 hours from surgery
Title
Bowel function
Description
The recovery of bowel function will be assessed
Time Frame
The first 24 hours from surgery
Title
Length of stay
Description
The length of stay after surgery will be assessed
Time Frame
Day after surgery

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Patients undergoing to robotic-assisted laparoscopic radical prostatectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Marinangeli, MD
Organizational Affiliation
San Salvatore Academic Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
San Salvatore Academic Hospital
City
Coppito
State/Province
L'Aquila
ZIP/Postal Code
67100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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