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NCT Number: NCT04029987

Bilateral Ultrasound-Guided Intra Muscular Quadratus Lumborum Block Versus Trans Muscular Quadratus Lumborum Block for Peri-Operative Analgesia in Abdominal Surgeries in Pediatric Patients. A Comparative Controlled Randomized Study.

To compare between the intra muscular quadratous lamborum and the Trans muscular quadratous lamborum in pediatric population under going abdominal surgeries regards to first request of rescue analgesia, degree of pain relief, effect on hemo dynamic stability and incidence of complications.

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Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abu ElReesh hospital, Cairo university Hospital,Kasr Alini

Cairo, 11562, Egypt

About this study

The investigators hypothesized that an ultrasound guided quadratous lamborum block would prove successful peri-operative analgesia for abdominal surgeries in pediatric patients, and that Intra muscular quadratous lamborum is non inferior to Trans muscular blockade with the advantage of being safer (away from the peritoneum and retroperitoneal organs) and with the assumption that sarcolemmal layer in pediatrics should not resist the diffusion of the injectant from within the muscle out, to reach the inter fascial plane where the targeted nerves are found and cause an efficient blockade.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children age starting from 5 to 12 years.
  • Genders eligible for study: both sexes.
  • American Society Of Anesthesia (ASA) I-III.
  • Scheduled to undergo laparoscopy.

Exclusion criteria

  • Refusal of regional block or patients requiring emergency procedures.
  • Known Local Anesthetics drug sensitivity
  • Bleeding disorders with International Normalised Ratio (INR) > 1.5 and/or platelets < 100 000.
  • Skin lesions or wounds at site of proposed needle insertion.
  • Evidence of peritonitis or septicemia.
  • Hepatic disease or enlargement.

Treatment and study plan

Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.

Procedure

A 22 G echogenic needle will be inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the Quadratus Lumborum and the Psoa Major muscles through the Quadratus Lumborum muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.

Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.

Procedure

A 22 G echogenic needle will be inserted in plane from ventral (lateral) edge of the probe and advanced until penetration of QL muscle fascia is observed. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.

Control

Procedure

Conventional analgesia

Primary outcomes

  1. Time of the first postoperative analgesic request

    Time frame: starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours

    (duration of the block, time spent post-operative before rescue opioid is needed at pain score of 6 or higher, up to 12 hours post operative.

Secondary outcomes

  1. total opioid consumption over the first 12 hours.

    Time frame: through out the first 12 hours post operative.

    rescue analgesia in the form of intravenous nalbuphine 0.1 milligram/Kilogram will be given for a Wong-Baker Faces Scale more than 4 up to 12 hours post operative.

  2. Pain score up to 12 hours after surgery.

    Time frame: through out the first 12 hours post operative.

    Postoperative pain score for each patient will be assessed by Wong-Baker Faces Scale at the following intervals: 15, 30, and 60 min, 6, and 12 hours after surgery.

  3. Block failure

    Time frame: through out the first hour post operative.

    a failed block is where the patient requires more than two doses of rescue analgesia in the first hour postoperatively

  4. Ease of performance of each technique

    Time frame: through out the block performance time

    Easiness of performance of the technique, rated on a simple verbal scale easy/moderately difficult/difficult) and defined as follows:

    • Easy block: successful block after the 1st skin puncture.
    • Moderately difficult block: successful block after more than one puncture or with the need for needle redirection or image optimization (as adjustment of depth, gain, or focus to visualize the needle path)
    • Difficult block: successful block after more than one puncture and with the with the need for needle redirection and image optimization

  5. Block performance time

    Time frame: starting from probe contact with skin till 30 minutes.

    Block performance time in minutes which is the time from probe contact with skin till needle withdrawal

  6. The incidence of post block adverse effects

    Time frame: starting after the block is given up to the first 12 hours post operative

    incidence of complications, such as:

    • postoperative nausea and vomiting, urinary retention, lower limb weakness
    • injury to the underlying structures (injury to the liver or a viscus), or hematoma formation as recorded under ultrasound guidance
    • need of postoperative mechanical ventilation or ICU admission
    • LA toxicity.

Other outcomes

  1. patient's heart rate

    Time frame: starting from 5 minutes after intubation till 30 minutes after extubation

    heart rate will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area.

  2. patient's systolic blood pressure

    Time frame: starting from 5 minutes after intubation till 30 minutes after extubation

    systolic blood pressure will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area.

  3. patient's diastolic blood pressure

    Time frame: starting from 5 minutes after intubation till 30 minutes after extubation

    diastolic blood pressure will be recorded at the following intervals: T0 (baseline); 5 minutes after intubation, T1; 1 minute after skin incision, T2; 15 minutes after skin incision, T3; 30 minutes after skin incision, T4; 60 minutes after skin incision, T5; 90 minutes after skin incision, T6; 5 minutes after extubation, T7; 30 minutes after extubation in the recovrery area.

  4. intraoperative administration of extra analgesic dose of fentanyl

    Time frame: starting from 10 minutes after the chosen block is given till extubation.

    Number of patients in each group who needed intraoperative administration of extra analgesic dose of fentanyl 0.5 microgram/kilogram),in patients showing increase in heart rate and/or arterial blood pressure 10 minutes after returning to supine position after the block is given, by more than 20% of baseline values (5 minutes after intubation) in response to surgical stimulus or thereafter throughout the whole operation.

  5. Duration of surgery

    Time frame: starting from skin incision up to skin closure.

    time in minutes from skin incision till skin closure

  6. Duration of general anesthesia

    Time frame: starting from induction of anesthesia till extubation

    time in minutes from induction of GA till extubation

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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