Clinical trial 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: age:5-12, American Society of Anesthesia I-III, abdominal laparoscopies, randomly allocated into one of the study groups, randomization sequence will be concealed in sealed envelopes with alphabetic codes. The identifiers will be attached to the opened envelopes and secured by dedicated person independent of randomization proceedings. Patients, parents and data analysts will be blinded to group assignments.

The groups:

* group A → Trans muscular quadrous lamborum block (n=22)
* group B → Intra muscular quadrous lamborum block (n=22)
* group c → control (n=22) will receive conventional analgesia. Sample size Starting number of 22 patients for each group, Recalculation of the sample size will be carried out after studying 10 patients per group.

The alpha error is set at 0.05 and the study power is 0.95.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time of the first postoperative analgesic request
timeFrame: starting 15 minutes post extubation, then at time intervals of 30 minutes , 60 minutes, 6 hours and 12 hours
Secondary outcomes:
measure: total opioid consumption over the first 12 hours.
timeFrame: through out the first 12 hours post operative.
measure: Pain score up to 12 hours after surgery.
timeFrame: through out the first 12 hours post operative.
measure: Block failure
timeFrame: through out the first hour post operative.
measure: Ease of performance of each technique
timeFrame: through out the block performance time
measure: Block performance time
timeFrame: starting from probe contact with skin till 30 minutes.
measure: The incidence of post block adverse effects
timeFrame: starting after the block is given up to the first 12 hours post operative
Other outcomes:
measure: patient's heart rate
timeFrame: starting from 5 minutes after intubation till 30 minutes after extubation
measure: patient's systolic blood pressure
timeFrame: starting from 5 minutes after intubation till 30 minutes after extubation
measure: patient's diastolic blood pressure
timeFrame: starting from 5 minutes after intubation till 30 minutes after extubation
measure: intraoperative administration of extra analgesic dose of fentanyl
timeFrame: starting from 10 minutes after the chosen block is given till extubation.
measure: Duration of surgery
timeFrame: starting from skin incision up to skin closure.
measure: Duration of general anesthesia
timeFrame: starting from induction of anesthesia till extubation
Locations:
city: Cairo
country: Egypt
facility: Abu ElReesh hospital, Cairo university Hospital,Kasr Alini
Study officials:
References: