Comaprison Between QLB and ESPB in Patients for PCNL Operation

September 4, 2022 updated by: Peter Bassem Halim Gadelsyed, Assiut University

Comparison Between Ultrasound Guided Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy

comparing the subcostal oblique Quadratus Lumborum block and the Erector Spinae plane block in patients undergoing percutaneous nephrolithotomy operation to get the best and longest postoperative analgesic effect.

Study Overview

Detailed Description

Here the investigators are going to compare between the Anterior approach for the subcostal oblique Quadratus Lumborum block (QLB) and the Erector Spinae Plane Block (ESPB) to determine their level of spread and their value in controlling postoperative pain in patients scheduled for Percutaneous Nephrolithotomy surgery. We hypothesized that quadratus lumborum is not inferior regarding the duration of analgesia when compared to erector spinae in patients undergoing percutaneous nephrolithotomy under general anesthesia.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt, 71111
        • Assiut University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both sex
  • Age: 18-60
  • ASA (American Society of Anesthesiologists) class I and II
  • Elective surgery
  • Patients undergoing PNL surgery

Exclusion Criteria:

  • Patient's refusal
  • Allergy or contraindications to drugs used in the study
  • Emergency surgery
  • Psychiatric disorders
  • Severely co-morbid patients
  • Inflammation or infection over injection site
  • Bleeding diathesis; INR more than 1.5 and Platelet count less than 100,000/mm3
  • Peripheral neuropathy
  • Obese patients BMI ≥35
  • Patients on previous opioid therapy
  • Pre-operative haemoglobin <10 mg/dl
  • Inability to properly describe postoperative pain to investigators
  • Coagulation abnormalities
  • History of drug addiction or alcohol abuse
  • History of Previous renal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: QLB
The patient is in the prone position, an ultrasound probe is placed in a transverse, oblique, and paramedian orientation approximately lateral to the posterior axillary line. The needle is then inserted in-plane from the medial side of the transducer and advanced laterally to enter the interfascial plane between the Quadratus Lumborum muscle and the kidney. We confirmed that the local anesthetic appeared to press down the kidney in the ultrasound image
patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney. The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle. 20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered. In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected.
Active Comparator: ESPB
Using aseptic technique, an ultrasound probe is placed at the T9 vertebral level. After identifying the ribs and sliding towards the midline in a longitudinal parasagittal orientation, the overlying Erector Spinae is identified by visualization of the transition between the rib and transverse apophysis a block needle is inserted in plane with ultrasound beam and is advanced in a cephalo-caudal direction until the tip contacted the transverse process.
patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney. The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle. 20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered. In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia
Time Frame: 48 hours
Total opioid consumption during the first 48hours postoperatively.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia
Time Frame: 24 hours
first Analgesic request postoperatively.
24 hours
episodes of nausea and vomiting
Time Frame: within 24 hours postoperative
to investigate if there is or not.
within 24 hours postoperative
Pain Scores using Visual Analog Scale (VAS) Scores
Time Frame: 24 hours postoperative.
VAS is a scale to determine the patient's pain level.
24 hours postoperative.
ambulation time
Time Frame: 5 days postoperative
time from the end of the surgery to the first time to out-of-bed activity
5 days postoperative
time of recovery of bowl movement
Time Frame: 5 days postoperative
time from the end of the surgery to the first time of bowl movement
5 days postoperative
patient satisfaction with anesthesia
Time Frame: 48 hours postoperative.
Patient satisfaction with anesthesia was assessed using a 5-point scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied)
48 hours postoperative.
postoperative length of hospital stay
Time Frame: within 2 weeks postoperative.
till time of discharge
within 2 weeks postoperative.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Amr Thabet, Lecturer, Assiut University
  • Study Chair: Alaa Attia, Professor, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 4, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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