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Completed

NCT Number: NCT05713643

ESPB vs PVB vs QLB After Pelvi-ureteric Surgeries

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.

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Key information

Conditions

Erector Spinae Plane Block Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Paravertebral Block Pathological Conditions, Signs and Symptoms Perceptual Disorders Quadratus Lumborum Block Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Fouad Algyar

Tanta, ElGharbiaa, 31511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESPB Technique

Procedure

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.

TPVB Technique

Procedure

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.

QLB Technique

Procedure

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.

Primary outcomes

  1. The total postoperative morphine consumption

    Time frame: 48 hours postoperatively

    Total amount of rescue analgesic in the first 48 hours postoperative will be measured.

Secondary outcomes

  1. Access post-operative pain scores

    Time frame: 48 hours Postoperatively

    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.

  2. Access time of first analgesic

    Time frame: 48 hours Postoperatively

    The time to first request of rescue analgesia will be recorded

  3. Patients' satisfaction after surgery.

    Time frame: 48 hours Postoperatively

    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).

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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