Quadratus Lumborum Block Using Loss-of-resistance Versus Ultrasound-guided Technique

This study aims to explore the feasibility of using loss-of-resistance technique for Quadratus Lumborum block (QLB). And to compare between the Ultrasound guided QLB type II and the loss-of-resistance technique for QLB as regards the degree and duration of analgesia and side effects.

Study Overview

• Status: Unknown
• Conditions: Quadratus Lumborum Block; Lower Abdominal Surgery
• Intervention / Treatment: Procedure: Loss-of-resistance Quadratus lumborum block; Procedure: General anesthesia; Procedure: Ultrasound-guided Quadratus lumborum block

Detailed Description

Quadratus lumborum block (QLB) is an abdominal plane block with increasing popularity. QLB is achieved by local anesthetic infiltration at the anterolateral aspect of quadratus lumborum muscle (QLB-I), or at the posterior aspect of the muscle (QLB-II), or transmuscular (QL-TM block). Ultrasound-guided technique is the usual route used for QLB performance. QLB had been considered a modification of transversus abdominis plane (TAP) block[4]. A cadaveric study had showed similar local anesthetic spread in both QL and TAP blocks.

TAP block could be performed by using either the ultrasound or loss-of-resistance technique; whilst, QLB is only performed using the ultrasound and the feasibility of loss-of-resistance technique had not been investigated for this block.

This study aims to explore the feasibility of using loss-of-resistance technique for QLB. And to compare between the Ultrasound guided QLB type II and the loss-of-resistance technique for QLB as regards the degree and duration of analgesia and side effects.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Hasanin; Phone Number: 1095076954; Email: ahmedmohamedhasanin@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for lower abdominal surgery under general anesthesia

Exclusion Criteria:

• Patient refusal to regional block,
• Pregnancy
• Coagulopathy
• Cognitive impairment
• Inflammation or infection at the puncture site
• History of allergic reaction to study medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loss-of-resistance; Patients in this group will receive Loss-of-resistance Quadratus lumborum block with 30 ml bupivacaine 0.25% in addition to general anesthesia.	Procedure: Loss-of-resistance Quadratus lumborum block; ِA blunted 22-G, 11 mm, short-bevel facet needle will be introduced in the paravertebral line at the level of L3 or L4, in 30-45 degree to the skin directing it laterally. Once the skin barrier is breached, the needle will be withdrawn back so that the tip lies just under the skin. The needle will be advanced through the posterior thoracolumbar fascia and a first fast "pop" sensation will be felt when the needle pierced it. With further advancement of the needle, a second deep pop will be felt after it pierces the middle thoracolumbar fascia. At this point, the needle will be in the plane of the quadratus lumborum block type II. After careful aspiration, the 30 mLs of local anaesthetic will be injected. The needle will be visualized by the ultrasound by another physician to ensure safety.; Procedure: General anesthesia; Patients will receive 2 mg of midazolam and 8 mg of dexamethasone IV; then, they will be transferred to the operating room to receive a standard general anesthetic. Perioperative monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2) and end-tidal carbon dioxide. Anesthesia will be induced by propofol 1.5-2.5 mg/kg, atracurium 0.5 mg/kg, and fentanyl 2 mcg/kg to facilitate the insertion of an endotracheal tube. Anesthesia will be maintained by isoflurane 1-2% end-tidal concentration to maintain systolic arterial blood pressure and heart rate within + 20% of the baseline values. Ventilation will be adjusted to maintain normocapnia.
Active Comparator: Ultrasound-guided; Patients in this group will receive Ultrasound-guided Quadratus lumborum block type-II with 30 ml bupivacaine 0.25% in addition to general anesthesia.	Procedure: General anesthesia; Patients will receive 2 mg of midazolam and 8 mg of dexamethasone IV; then, they will be transferred to the operating room to receive a standard general anesthetic. Perioperative monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2) and end-tidal carbon dioxide. Anesthesia will be induced by propofol 1.5-2.5 mg/kg, atracurium 0.5 mg/kg, and fentanyl 2 mcg/kg to facilitate the insertion of an endotracheal tube. Anesthesia will be maintained by isoflurane 1-2% end-tidal concentration to maintain systolic arterial blood pressure and heart rate within + 20% of the baseline values. Ventilation will be adjusted to maintain normocapnia.; Procedure: Ultrasound-guided Quadratus lumborum block; A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 30 ml of local anesthetic (bupivacaine 0.25 %) will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesia	The time between the end of the surgery and the first analgesia request	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine consumption	The total amount of morphine needed during the first 24 hours	24 hours
Intraoperative extra-analgesia requirements	The total amount of analgesic drug boluses	3 hours
visual analogue pain score at rest to assess the pain severity	the grade of pain experienced by the patient at rest graded from 0 to 10. The lower the value, the better the score	24 hours
Visual analogue pain score at movement to assess the pain severity	the grade of pain experienced by the patient at movement graded from 0 to 10. The lower the value, the better the score	24 hours
Systolic blood pressure	the systolic blood pressure measured in mmHg	24 hours
Heart rate	The number of heart beats per minute	24 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Ahmed M Mukhtar, Head of research committee section in anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Anticipated): September 15, 2018
• Study Completion (Anticipated): September 20, 2018

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: October 29, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: N-88-2017

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