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

NCT03328481 | Unknown DMC

• 1 other identifier: N-88-2017
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Abdominal Surgery; Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

  The time between the end of the surgery and the first analgesia request

  24 hours

Secondary Outcomes (6)

• Postoperative morphine consumption

  24 hours

• Intraoperative extra-analgesia requirements

  3 hours

• visual analogue pain score at rest to assess the pain severity

  24 hours

• Visual analogue pain score at movement to assess the pain severity

  24 hours

• Systolic blood pressure

  24 hours

Study Arms (2)

Loss-of-resistance

EXPERIMENTAL

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; Procedure: General anesthesia

Ultrasound-guided

ACTIVE COMPARATOR

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: Ultrasound-guided Quadratus lumborum block; Procedure: General anesthesia

Interventions

Loss-of-resistance Quadratus lumborum block PROCEDURE

ِ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 Once the skin barrier is breached, the needle will be withdrawn back so that the tip lies just under the skin.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.

Loss-of-resistance

Ultrasound-guided Quadratus lumborum block PROCEDURE

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.

Ultrasound-guided

General anesthesia PROCEDURE

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.

Loss-of-resistance; Ultrasound-guided

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for lower abdominal surgery under general anesthesia

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Ahmed M Mukhtar

  Head of research committee section in anesthesia department

  STUDY DIRECTOR

Central Study Contacts

Ahmed M Hasanin

CONTACT

1095076954; ahmedmohamedhasanin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 1, 2017
• Study Start: May 28, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 20, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)