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

NCT ID: NCT05278598

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-27
• Study Completion Date: 2023-08-16

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.

Conditions

Cancer, Bladder; Surgery; Anesthesia; Analgesia; Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

ESPB group

Erector Spinae Plane Block

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block

Intervention Type: PROCEDURE

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.

TPVPB group

Thoracic Paravertebral Plane Block

Group Type: ACTIVE_COMPARATOR

Thoracic Paravertebral Plane Block

Intervention Type: PROCEDURE

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.

QLPB group

Quadratus Lumborum Plane Block

Group Type: ACTIVE_COMPARATOR

Quadratus Lumborum Plane Block

Intervention Type: PROCEDURE

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.

Interventions

Erector Spinae Plane Block

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

Thoracic Paravertebral Plane Block

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

Quadratus Lumborum Plane Block

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nazmy Edward Seif

OTHER

Sponsor Role: lead

Responsible Party

Nazmy Edward Seif

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Moustafa M Zalat, MSc

Role: PRINCIPAL_INVESTIGATOR

Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Nazmy S Michael, MD

Role: STUDY_DIRECTOR

Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Locations

Cairo University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

3USGPBPORC

Identifier Type: -

Identifier Source: org_study_id