Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia

Pain, Postoperative Clinical Trial

Official title:

Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block for Pain Relief in Children Undergoing Lower Abdominal Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646630
• Other study ID #: D141
• Status: Completed
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: September 2022
• Source: Fayoum University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications.

Description:

Regional anesthesia and analgesia techniques are commonly used during pediatric surgical practice to facilitate pain control, decrease parenteral opioid requirements and improve the quality of post-operative pain control and patient-parent satisfaction. The most commonly used technique is caudal anesthesia, which is generally indicated for urologic surgery, inguinal hernia repair and lower extremity surgery. The quadratus lumborum (QL) block is a recently introduced abdominal truncal block, used for somatic and visceral analgesia of both the upper and lower abdomen. It was first described by Blanco in 2007 . Currently, the QL block is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery . QL block allows the local anesthetics to spread between the posterior aspect of the quadratus lumborum muscle and the medial layer of the thoracolumbar fascia, which is close to the thoracic paravertebral space .

The ultrasound (US) has gained popularity among anesthesiologists performing regional anesthesia. Block success, and hence the efficacy would depend on the patient's anatomical variations and the anesthesiologist's skill level .

The use of ultrasound-guidance for peripheral nerve blocks (PNBs) offers many advantages. Direct visualization of the nervous and surrounding structures decreases the incidence of complications e.g. inadvertent intraneural or intravascular injection. Direct real-time observation of the local anesthetics spread ensures more accurate deposition .This leads to faster onset and longer duration of block, thus improves block quality. It also allows dose reduction of local anesthetics . It has been shown that when peripheral nerves are adequately imaged by ultrasound, the simultaneous use of the nerve stimulator offers no further advantages.

Following ethical committee approval of Anesthesia department, Fayoum University and obtaining informed consent from parents of each patient, fifty two patients will be randomized into 2 study groups. Each group contains 26 patients.

Methodology:

Preoperative Assessment:

All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications.

Operating Room Preparation & Equipment:

The ultrasound used will be Sonosite M Turbo (USA), the scanning probe will be the linear multi-frequency 13-6 MHz transducer (L25x13-6 MHz linear array). The needle used will be the stimuplex D needles manufactured by B Braun (Germany).

Perioperative Management:

All patients will be premedicated with IM midazolam 0.2 mg/kg and atropine 0.02 mg/kg. Perioperative monitoring will include continuous ECG, pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring.

Inhalational induction of general anesthesia (GA) will be performed with a face mask using sevoflurane 8% and 50% oxygen in air, and then an intravenous (IV) cannula will be inserted. Fentanyl will be administered intravenously at 1 μg/kg, and a laryngeal mask airway (Intavent

• Orthofix, Maidenhead, United Kingdom) will be used to secure the upper airway, with the patient kept spontaneously breathing. Anesthesia will be maintained with Isoflurane and 50% oxygen in air.

Surgery will be allowed to begin 10 minutes after block application. At the end of surgery, acetaminophen 15 mg/kg IV will be administered to all patients. Any complications occurring during the procedure will be recorded.

After completion of surgical procedure and emergence from anesthesia the patient will be referred to PACU. Quality of analgesia will be assessed using a FLACC scale at 30 minutes and at 1, 2, 4, 6, 12, and 24 hours postoperatively. Diclofenac sodium 1 mg/kg rectally will be given as rescue analgesia for patients in all study groups in PACU if FLACC scale > 4. Parents will be informed about the pain evaluation, and when patients had pain at home, parents will be instructed to give oral paracetamol 30 mg/kg. The anesthesiologist will record data received from the parents over the phone.

Statistical Analysis Sample size was calculated using the G* Power software version 3.1.7 analysis program (Heinirch Heine University, Dusseldorf, Germany) before the study. Depending on previous similar research with calculated effect size (d) 0.85, two tails (two sided), type 1 error 0.05 and increasing power of study to 90%, it was determined that each group should include at least 26 subject to obtain significant statistical value.

Collected data will be computerized and analyzed using statistical package for social science (SPSS) version 16. The results will be expressed as number and percentages for qualitative variables, mean, standard deviation and range for continuous data, median and inter-quartile range for quantitative discrete variables and scores.

To compare between groups, the chi-square will be used for qualitative variables, student t rest for comparing quantitative continuous variables between 2 groups, Mann Whitney U test to compare scores between 2 groups. Probability (P) value of less than 0.05 will be considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 15, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• Age 1-7 years

• American Society of Anesthesiologists physical status I-II

• Lower abdominal surgery

Exclusion Criteria:

• History of developmental delay or mental retardation

• Parent refusal

• History of allergic reactions to local anesthetics

• Rash or infection at the injection site

• Anatomical abnormality

• Bleeding disorders.

• History of cardiac, neurological, renal, hepatic diseases.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Quadratus Lumborum Block
Posterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25%
• Caudal Block
caudal block with 1 ml/kg of bupivacaine 0.25%.

Locations

Country	Name	City	State
Egypt	Fayoum University hospital	Madinat al Fayyum	Faiyum Governorate

Sponsors (2)

Lead Sponsor	Collaborator
Fayoum University Hospital	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090. — View Citation

Griffin J, Nicholls B. Ultrasound in regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:1-12. doi: 10.1111/j.1365-2044.2009.06200.x. Review. — View Citation

Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. Review. — View Citation

Liu SS, Ngeow J, John RS. Evidence basis for ultrasound-guided block characteristics: onset, quality, and duration. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S26-35. doi: 10.1097/AAP.0b013e3181d266f0. Review. — View Citation

Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time at which the first analgesia required	in hours	24 hours after procedure
Secondary	Pain assessment by the aid of FLACC score	F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score	30 minutes after operation
Secondary	Pain assessment by the aid of FLACC score	F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score	1 hour after operation
Secondary	Pain assessment by the aid of FLACC score	F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score	2 hours after operation
Secondary	Pain assessment by the aid of FLACC score	F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score	4 hours after operation
Secondary	Pain assessment by the aid of FLACC score	F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score	6 hours after operation
Secondary	Pain assessment by the aid of FLACC score	F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score	12 hours after operation
Secondary	Pain assessment by the aid of FLACC score	F:Face ,L:Legs, A:Activity, C:Cry, C:Consolability score	24 hours after operation
Secondary	number of analgesic doses for each patient	by oral paracetamol 30 mg/kg given by parents	24 hours after operation
Secondary	The general satisfaction score of parents	measured on a 5-point scale of 1.Extremely dissatisfied 2.Dissatisfied 3.Not satisfied, nor dissatisfied 4.Satisfied 5.Completely satisfied.	24 hours after operation
Secondary	Preoperative heart rate	in beat per minutes measured by electrocardiogram	5 minutes before operation
Secondary	Preoperative systolic blood pressure	in mm mercury measured by non-invasive blood pressure measurement	5 minutes before operation
Secondary	Preoperative diastolic blood pressure	in mm mercury measured by non-invasive blood pressure measurement	5 minutes before operation
Secondary	Intraoperative systolic blood pressure	in mm mercury measured by non-invasive blood pressure measurement	every 15 minutes till end of operation
Secondary	Intraoperative diastolic blood pressure	in mm mercury measured by non-invasive blood pressure measurement	every 15 minutes till end of operation
Secondary	Intraoperative heart rate	in beat per minutes measured by electrocardiogram	every 15 minutes till end of operation
Secondary	Incidence of hypotension	drop of blood pressure more than 20 % of baseline blood pressure	within one hour of the intervention
Secondary	Incidence of bradycardia	Heart rate below 50 beat per minute by electrocardiogram	Within one hour of the intervention
Secondary	Incidence of vascular puncture	as signs of local anesthetics toxicity	Within one hour of the intervention
Secondary	Incidence of convulsions	as signs of local anesthetics toxicity	Within one hour of the intervention
Secondary	Incidence of arrhythmias	as signs of local anesthetics toxicity	Within one hour of the intervention
Secondary	Incidence of paresthesia	as signs of local anesthetics toxicity	Within one hour of the intervention
Secondary	Incidence of hematoma formation	Recorded under ultrasound guidance	Within one hour of the intervention
Secondary	Incidence of injury to the underlying structures	Injury to the liver or a viscous	Within one hour of the intervention