Quadratus Lumborum Versus Transversus Abdominis Plane Block Versus Caudal Block for Postoperative Analgesia After Pediatric Inguinal Hernia : Double-Blinded Randomized Trial

NCT05442905 | Unknown

• 1 other identifier: 35565/6/22
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Multimodal analgesia (MMA) is the current standard practice to provide postoperative analgesia. The aim of this study is to compare the analgesic efficacy of quadratus lumborum (QL) block versus transversus abdominis plane (TAP) block versus caudal block as an adjunct to MMA. Methods: In a prospective, randomized, controlled study, 180 children of age 2 8 years and ASA grade Ӏ and ӀӀ, undergoing elective inguinal hernia surgery will be randomly allocated into 3 groups: Group Q (n = 60) will receive USG guided QL block with 0.7mL/kg of 0.25% bupivacaine and Group C (n = 60) will receive caudal block with 1mL/kg of 0.25% bupivacaine and Group T (n = 60) will receive USG guided TAP block with 0.5mL/kg of 0.25% bupivacaine. Postoperatively, all the subjects will be assessed at 2, 4, 6, 8, 12, 18, and 24 hours. The primary outcome will be the time to first analgesic request. The secondary outcomes will be the pain scores during rest and movement, number of doses of morphine, variation in hemodynamic parameters and adverse effects, if any.

Conditions

Quadratus Lumborum Block; Transversus Abdominis Plane Block; Caudal Block; Postoperative Pain; Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• The time to first analgesic request

  The time to first analgesic request is recorded by a nurse unaware about the typy of block.

  24 hours postoperatively

Study Arms (3)

Quadratus lumborum block group

ACTIVE COMPARATOR

will receive quadratus lumborum block the patient will be placed in lateral position, the probe will be placed on the crista iliaca anterior superior. After the external oblique, internal oblique, and transversus abdominis muscles will be seen, the probe will be moved to the posterior and the quadratus lumborum muscle will be observed. A 22-gauge, 80 mm insulated Quince-type needle (Uniplex; Pajunk, Geisingen, Germany) will be moved from the anterolateral plane to the posteromedial plane, and confirmation will be made using 0.5 mL/kg saline; after a negative aspiration, 0.7 mL/kg (0.25%) bupivacaine will be applied to the posterior of the quadratus lumborum muscle and the thoracolumbar fascia in between the quadratus lumborum and latissimus dorsi muscles.

Drug: propofol; Drug: Atracurium Besylate; Drug: sevoflurane

Transversus abdominis block group

ACTIVE COMPARATOR

will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. The three layers of muscles, the external oblique, the internal oblique, and the transversus abdominis will be identified. Using the in-plane technique, needle will be inserted (from anterior to posterior direction) until the tip of the needle will reach between the internal oblique and the transversus abdominis. Hydro dissection with 1-2 mL saline will be done to separate the fascial layers. After the correct localization, 20 mL of the drug will beinjected with repeated aspiration to avoid the accidental intravascular injection.

Drug: propofol; Drug: Atracurium Besylate; Drug: sevoflurane

Caudal block group

ACTIVE COMPARATOR

will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position. with all aseptic measures caudal block will be performed using 25 G needle in left lateral decubitus position. Needle position will be confirmed by the pop felt during penetration of the sacrococcygeal ligament, further ensured by doing whoosh test using 0.5 mL of air injection 0.25% bupivacaine 1mL/kg will be administered after negative aspiration of blood and CSF. Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).

Drug: propofol; Drug: Atracurium Besylate; Drug: sevoflurane

Interventions

propofol DRUG

Anesthesia will be induced with propofol 2-3mg/kg

Also known as: Intravenous anesthesia

Caudal block group; Quadratus lumborum block group; Transversus abdominis block group

Atracurium Besylate DRUG

Atracurium 0.15mg/kg used for muscle relaxation before intubation

Also known as: Muscle relaxant

Caudal block group; Quadratus lumborum block group; Transversus abdominis block group

sevoflurane DRUG

sevoflurane(1%-2%) used during anesthesia

Also known as: Inhalational anesthesia

Caudal block group; Quadratus lumborum block group; Transversus abdominis block group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• patients of ASA physical status Ӏ or ӀӀ
• scheduled for inguinal hernia surgery

You may not qualify if:

• lack of consent by parents
• blood coagulopathies.
• local infection.
• vertebral deformity.
• allergy to drugs

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Interventions

Propofol; Anesthesia, Intravenous; Atracurium; Sevoflurane

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthesia; Anesthesia and Analgesia; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The 3 analgesic twchniques were described to the parents preoperatively and they will agree to give their child either of them and To maintain blinding, postoperative evaluation of pain scores will be done by an anesthesiologist, who will be not involved in administering block.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Group Q: will receive quadratus lumborum block the patient will be placed in lateral positionGroup T: will receive TAP block with 0.7mL/kg of 0.25% bupivacaine under US guidance. A linear high frequency ultrasound probe (6-13 MHz) will be placed transversely in the mid axillary line between the iliac crest and the costal margin. Group C: will receive caudal block with 1mL/kg of 0.25% bupivacaine, with children in left lateral position.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07