ESPB vs PVB vs QLB After Pelvi-ureteric Surgeries
Erector Spinae Plane Block Versus Paravertebral Block Versus Quadratus Lumborum Block on Postoperative Analgesia After Pelvi-ureteric Surgeries: A Randomized Double-Blinded, Non-inferiority Trial
1 other identifier
interventional
90
1 country
1
Brief Summary
The aim of this study is to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block versus quadratus lumborum block on postoperative analgesia after pelvi-ureteric surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2023
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2023
CompletedNovember 22, 2023
November 1, 2023
9 months
January 26, 2023
November 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The total postoperative morphine consumption
Total amount of rescue analgesic in the first 48 hours postoperative will be measured.
48 hours postoperatively
Secondary Outcomes (3)
Access post-operative pain scores
48 hours Postoperatively
Access time of first analgesic
48 hours Postoperatively
Patients' satisfaction after surgery.
48 hours Postoperatively
Study Arms (3)
ESPB group
ACTIVE COMPARATORTPVB group
ACTIVE COMPARATORQLB group
ACTIVE COMPARATORInterventions
The patient will be in sitting position. The probe will be positioned with longitudinal alignment, 3 cm lateral to the spinous procedure of T8 to obtain a parasagittal view. An echogenic needle will be introduced from the caudal end of the probe and advanced in-plane direction until the needle tip hit the tip of the transverse process. Bupivacaine will be afterwards injected into the erector spinae plane block. Linear spread cranially and caudally below the muscle upon injection will be visualized on the US screen indicating successful block.
The patient will be in sitting position. The probe will be positioned with longitudinal alignment, 3 cm lateral and parallel to 8th spinous process till transverse process, superior costotransverse ligament, and pleura will be visualized then lateral tilt of the probe was done for better visualization of the PVS between the superior costotransverse ligament and the pleura. An echogenic needle was introduced at caudal end of transducer using the in-plane technique till piercing the superior costotransverse ligament . Bupivacaine will be injected into the PVS with downward displacement of the pleura indicating a successful block.
The patient will be in lateral position. The probe will be placed above the iliac crest. The Petit's triangle will be identified. The three abdominal muscles (i.e., the external oblique, internal oblique and transversus abdominus muscles) will be detected. Both the external oblique and internal oblique muscles will be followed posteriorly until the layers of the thoracolumbar fascia appear as a bright hyperechogenic line. The quadratus lumborum muscle appears below to the latissimus dorsi muscle. While performing the quadratus lumborum block, "Shamrock sign" is identified; the transverse process of L4 appears as a stem whereas the three muscles psoas muscle, quadratus lumborum muscle and erector spinae appear as the leaves. A 22G (50mm) needle was inserted using an in-plane technique along the posterior edge of the ultrasound probe in the anteromedial direction. The needle tip was placed between the quadratus lumborum muscle and the Erector spinae muscle.
Eligibility Criteria
You may qualify if:
- Age 18-65 years
- Both genders
- American Society of Anesthesiologists (ASA) physical status I-III
- Undergoing elective pelvi-ureteric surgeries.
You may not qualify if:
- Body Mass Index \> 30 kg/m2.
- Contraindication of deep nerve block such as allergic to anesthetic drug, coagulation disorder, and infection at the injection site.
- Chronic opioids dependence or chronic pain over 3 months.
- Use of medication such as gabapentin-pregabalin could affect pain perception.
- Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.
- Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mohammad Fouad Algyar
Tanta, ElGharbiaa, 31511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Study Record Dates
First Submitted
January 26, 2023
First Posted
February 6, 2023
Study Start
January 30, 2023
Primary Completion
November 5, 2023
Study Completion
November 5, 2023
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- One year after the end of the study
The data will be available under a reasonable request from the corresponding author.