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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Lower Abdominal Surgery, Quadratus Lumborum Block

Being tested

Loss-of-resistance Quadratus lumborum block, Ultrasound-guided Quadratus lumborum block, General anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Loss-of-resistance Quadratus lumborum blockProcedure or surgery

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 Once the skin barrier is breached, the needle will be withdrawn back so that the tip lies just under the skin.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

• Ultrasound-guided Quadratus lumborum blockProcedure or surgery

  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.

• General anesthesiaProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Duration of analgesia

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

   Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted1 Nov 2017
2. Study start28 May 2018
3. Primary completion15 Sep 2018 (estimated)
4. Study completion20 Sep 2018 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Lower Abdominal SurgeryStudies of the same condition, open and under way.
• More trials run by Cairo UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.