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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Erector Spinae Plane Block; Quadratus Lumborum Block; Paravertebral Block
• Intervention / Treatment: Procedure: ESPB Technique; Procedure: TPVB Technique; Procedure: QLB Technique

Detailed Description

Opioid-based analgesia plays a significant role in the control of postsurgical pain; however, use of opioid may lead to significant side effects (e.g., nausea and vomiting) and adverse events (e.g. respiratory depression), which may be associated with significantly longer hospital stays and higher hospital costs in the postsurgical setting .

Thoracic paravertebral block (TPVB) is a classic trunk block with definite analgesic effect for both somatic and visceral pain.

Quadratus Lumborum block (QLB) is a widely used regional anesthesia technique as well. It has been used for reducing postoperative pain after cesarean section, laparotomy or laparoscopic procedure and hip surgery.

Erector spinae plane block (ESPB) is a novel inter-fascial plane block first introduced by Forero et al. in 2016 , providing wide-ranging analgesia in lung surgery, laparoscopy, mastectomy, and pediatric surgery. The proposed mechanism of ESPB is that distribution of local anesthetic solution spreads into the para-vertebral space and epidural space, which then blocks the dorsal, ventral, and traffic branches of spinal nerve.

ESPB, TPVB and QLB III have been shown to improve analgesic outcome after urological surgeries.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • ElGharbiaa
    • Tanta, ElGharbiaa, Egypt, 31511
      • Mohammad Fouad Algyar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65 years
• Both genders
• American Society of Anesthesiologists (ASA) physical status I-III
• Undergoing elective pelvi-ureteric surgeries.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESPB group	Procedure: ESPB Technique; 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.
Active Comparator: TPVB group	Procedure: TPVB Technique; 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.
Active Comparator: QLB group	Procedure: QLB Technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total postoperative morphine consumption	Total amount of rescue analgesic in the first 48 hours postoperative will be measured.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access post-operative pain scores	Postoperative pain will be accessed using Numeric Rating Scale which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.	48 hours Postoperatively
Access time of first analgesic	The time to first request of rescue analgesia will be recorded	48 hours Postoperatively
Patients' satisfaction after surgery.	The degree of patient satisfaction will be assessed on a 5-point scale: (0= extremely dissatisfied, 1= unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied), 4= extremely satisfied).	48 hours Postoperatively

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): November 5, 2023
• Study Completion (Actual): November 5, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MKSU 50-12-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available under a reasonable request from the corresponding author.
• IPD Sharing Time Frame: One year after the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No