Comaprison Between QLB and ESPB in Patients for PCNL Operation

NCT04277611 | Completed

• 1 other identifier: QLB and ESPB comparison
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative

Keywords

pain management; Nephrolithotomy; QLB; ESPB; Erector Spinae; Quadratus Lumborum; Anesthesia; ultrasound; regional anethesia

Outcome Measures

Primary Outcomes (1)

• Analgesia

  Total opioid consumption during the first 48hours postoperatively.

  48 hours

Secondary Outcomes (7)

• Analgesia

  24 hours

• episodes of nausea and vomiting

  within 24 hours postoperative

• Pain Scores using Visual Analog Scale (VAS) Scores

  24 hours postoperative.

• ambulation time

  5 days postoperative

• time of recovery of bowl movement

  5 days postoperative

Study Arms (2)

QLB

ACTIVE COMPARATOR

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

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

ESPB

ACTIVE COMPARATOR

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.

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

Interventions

Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block. PROCEDURE

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.

ESPB; QLB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Amr Thabet, Lecturer

  Assiut University

  STUDY DIRECTOR

• Alaa Attia, Professor

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor in Anesthesia, postoperative ICU and pain management department

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: April 20, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)