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3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy

Primary Purpose

Cancer, Bladder, Surgery, Anesthesia

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Thoracic Paravertebral Plane Block
Quadratus Lumborum Plane Block
Sponsored by
Nazmy Edward Seif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Bladder focused on measuring Erector spinae plane block, Quadratus lumborum plane block, Paravertebral block, Ultrasound-guided, Radical cystectomy, Analgesia, Anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) class II - III.
  • Adult patients scheduled for radical cystectomy.

Exclusion Criteria:

  • Patient refusal.
  • Uncooperative patients.
  • Patients with known allergies to local anesthetics.
  • Bleeding disorders or coagulopathy.
  • Anatomical abnormality or infection at injection site.
  • Patients receiving opioids for chronic analgesic therapy.
  • Spinal anesthesia or any other regional anesthesia.

Sites / Locations

  • Cairo University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

ESPB group

TPVPB group

QLPB group

Arm Description

Erector Spinae Plane Block

Thoracic Paravertebral Plane Block

Quadratus Lumborum Plane Block

Outcomes

Primary Outcome Measures

Morphine consumption.
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2022
Last Updated
August 28, 2023
Sponsor
Nazmy Edward Seif
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1. Study Identification

Unique Protocol Identification Number
NCT05278598
Brief Title
3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy
Official Title
Comparative Assessment of 3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 27, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nazmy Edward Seif

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Radical cystectomy is the gold standard treatment for muscle invasive bladder cancer as well as some T1 and non-invasive disease. It is a major operation with significant perioperative morbidity and complications. Pain is one of the most important complications to be managed. Regional blocks as a part of multi-modal analgesia are considered main strategies of Enhanced Recovery after Surgery (ERAS) decreasing post-operative complications including post-operative pain and post-operative hospital stay. They also have an upper hand over systemic intravenous opioids decreasing the risk for post-operative delirium specially in old age patients. Thoracic paravertebral plane block (TPVPB), intra muscular quadratus lumborum plane block (QLPB) and erector spinae plane block (ESPB) are among these regional anesthesia techniques for pain management. Erector spinae plane block is an emerging block, with low risk and more feasibility, but efficacy hasn't been compared to quadratus lumborum and paravertebral plane blocks altogether in radical cystectomy surgeries. All these blocks are effective in reducing postoperative pain and the need of analgesia in radical cystectomy surgery; this is a comparative study between the three blocks in this population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Bladder, Surgery, Anesthesia, Analgesia, Block
Keywords
Erector spinae plane block, Quadratus lumborum plane block, Paravertebral block, Ultrasound-guided, Radical cystectomy, Analgesia, Anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESPB group
Arm Type
Active Comparator
Arm Description
Erector Spinae Plane Block
Arm Title
TPVPB group
Arm Type
Active Comparator
Arm Description
Thoracic Paravertebral Plane Block
Arm Title
QLPB group
Arm Type
Active Comparator
Arm Description
Quadratus Lumborum Plane Block
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
After skin sterilization, ESP block will be performed at the level of T9. A curvilinear high-frequency ultrasound transducer will be placed sagittal 3 cm lateral to T9 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 30 mL of 0.25% bupivacaine will be injected. Sonographic confirmation of the local anesthetic spread will be seen as an anechoic shadow in the paravertebral spaces from T7 to T12. This procedure will be done on both sides.
Intervention Type
Procedure
Intervention Name(s)
Thoracic Paravertebral Plane Block
Intervention Description
After skin sterilization, curvilinear high-frequency ultrasound transducer will be used to visualize the T10 paravertebral space in the paramedian sagittal plane. An injection into the paravertebral space will spread to multiple adjacent dermatomes, so exact identification of a specific level will be not necessary. A 22-gauge spinal needle will be inserted in-plane relative to the ultrasound probe and slowly be directed from lateral to medial until its tip was located at the apex of the paravertebral space and the endpoint for successful block will be anterior displacement of the pleura by injected local anesthetic where a single injection of 30 ml of 0.25% bupivacaine will be injected. This procedure will be done on both sides.
Intervention Type
Procedure
Intervention Name(s)
Quadratus Lumborum Plane Block
Intervention Description
After skin sterilization, curvilinear high-frequency ultrasound transducer will be positioned horizontally in the anterior axillary line halfway between the subcostal margin and iliac crest, to locate the triple abdominal muscle layers, then the probe will be relocated subsequently to the posterior axillary line until the quadratus lumborum muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process, this is a well-recognizable pattern of a shamrock with three leaves. A 22-gauge spinal needle will be inserted in-plane relative to the ultrasound probe passing in posterior to anterior direction through the quadratus lumborum to reach the border between it and psoas major, where 30 ml of 0.25% bupivacaine will be injected. This procedure will be done on both sides.
Primary Outcome Measure Information:
Title
Morphine consumption.
Description
Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) class II - III. Adult patients scheduled for radical cystectomy. Exclusion Criteria: Patient refusal. Uncooperative patients. Patients with known allergies to local anesthetics. Bleeding disorders or coagulopathy. Anatomical abnormality or infection at injection site. Patients receiving opioids for chronic analgesic therapy. Spinal anesthesia or any other regional anesthesia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa M Zalat, MSc
Organizational Affiliation
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nazmy S Michael, MD
Organizational Affiliation
Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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3 Ultrasound Guided Plane Blocks for Perioperative Analgesia in Patients Undergoing Radical Cystectomy

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