Ultrasound Guided Anterior Quadratus Lumborum Block

Ultrasound Guided Anterior Quadratus Lumborum Block for Postoperative Pain After Percutaneous Nephrolithotomy: Randomized Controlled Trial

Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain, despite a multimodal analgesic regime.

This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB) in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Ultrasound
• Intervention / Treatment: Drug: Morphine Sulfate; Procedure: Group A; Procedure: Group P

Detailed Description

Many analgesic procedures such as NSAID, opioid and regional anesthesia procedures are used as a part of multimodal analgesia for postoperative Percutaneous nephrolithotomy pain.

In this study we will use the ultrasound -guided anterior Quadratus Lumborum Block . Local anesthesic will be injected between quadratus lumborum muscle and psoas muscle with ultrasound.Analgesic effect of this block will be detected by using morphine consumption and visual analogue scale .

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey
    • University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent elective Percutaneous nephrolithotomy

Exclusion Criteria:

• Previous history of opioid use preoperatively,

  • Allergy to local anesthetics,
  • The presence of any systemic infection,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+PCA (morphine)	Drug: Morphine Sulfate; patient-controlled analgesia (PCA) morphine; Other Names: Morphine; Procedure: Group A; Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 Bupivacaine; Other Names: Bupivacaine
Sham Comparator: Group P; Group P:PCA (morphine)	Drug: Morphine Sulfate; patient-controlled analgesia (PCA) morphine; Other Names: Morphine; Procedure: Group P; Group P:patient-controlled analgesia (PCA) morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0= no pain, 10=intolerable pain)	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphine consumption	morphine consumption	Postoperative 24 hours
side effect profile	side effect profile (Nausea and vomiting scale,Hypotension,Ramsay Sedation Scale); Nausea and vomiting scale (nausea-vomiting scale (NVS): 1. No nausea is present, 2. Mild nausea is present. 3. Severe nausea is present. 4. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.; Hypotension; Ramsay Sedation Scale (Ramsay Sedation Scale (RSS) : 1. Anxiety, agitation are present; 2. Cooperated, awake; 3. Sedatized, response to commands; 4. Sleepy, immediately awoken by auditory stimulus or glabella tap; 5. Sleepy, deep response to auditory stimulus or glabella tap and 6. Sleepy, no response to auditory stimulus or glabella tap )	Postoperative 24 hours
additional analgesic use	additional analgesic use	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Bursa Yüksek İhtisas Education and Research Hospital
• Investigators: Principal Investigator: Korgün Ökmen, M.D, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): August 18, 2018
• Study Completion (Actual): August 18, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: pain; ultrasound; quadratus lumborum block; percutaneous nephrolithotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: BYIEAH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No