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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277611
Other study ID # QLB and ESPB comparison
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2021
Est. completion date June 30, 2022

Study information

Verified date September 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date June 30, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.
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.

Locations

Country Name City State
Egypt Assiut University Hospitals Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Analgesia Total opioid consumption during the first 48hours postoperatively. 48 hours
Secondary Analgesia first Analgesic request postoperatively. 24 hours
Secondary episodes of nausea and vomiting to investigate if there is or not. within 24 hours postoperative
Secondary Pain Scores using Visual Analog Scale (VAS) Scores VAS is a scale to determine the patient's pain level. 24 hours postoperative.
Secondary ambulation time time from the end of the surgery to the first time to out-of-bed activity 5 days postoperative
Secondary time of recovery of bowl movement time from the end of the surgery to the first time of bowl movement 5 days postoperative
Secondary patient satisfaction with anesthesia 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.
Secondary postoperative length of hospital stay till time of discharge within 2 weeks postoperative.
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