NCT05713643

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

January 26, 2023

Last Update Submit

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 COMPARATOR
Procedure: ESPB Technique

TPVB group

ACTIVE COMPARATOR
Procedure: TPVB Technique

QLB group

ACTIVE COMPARATOR
Procedure: QLB Technique

Interventions

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.

ESPB group

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.

TPVB group
QLB TechniquePROCEDURE

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.

QLB group

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

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

The data will be available under a reasonable request from the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
One year after the end of the study

Locations