Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Laparoscopic Appendicectomy

NCT04031196 | Completed

• 1 other identifier: 5504-16-9-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

QL block has been recently described for chronic pain following abdominal hernia repair, and for postoperative analgesia following abdominal surgery as it leads to complete pain relief in the dermatomal area from (T6 - L1). Theoretically, QL blocks might give better and longer-lasting analgesia compared to the US-guided anterior TAP block due to a spread to the thoracic paravertebral space and sympathetic nerves in the thoracolumbar fascia, so visceral afferent pathways to the medulla can be blocked.

Conditions

Children; Appendicitis

Keywords

Pediatric; Quadratus Lumborum; regional anesthesia

Outcome Measures

Primary Outcomes (3)

• changes in intraoperative mean arterial blood pressure (MAP) values

  (mm Hg)

  at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)

• changes in intraoperative heart rate (HR) values

  (beats/minute)

  at base line (To), 3 minutes(min) after induction of general anesthesia, 10 min after intubation (immediately before performing the block (T1)), 15 min after performing the block (T2),and intraoperative values every 15 min till the end of surgery(T3)

• changes in the degree of pain perception by patient

  measured by visual analogue scale(VAS), The patient was trained to report the level of pain on VAS scale from 0 to 10 (where 0 indicates no pain and 10 indicates the most severe pain).

  Patients were assessed in the immediate post operative period and then at 2 hour(h), 4h, 6h , 8h , 12 h, 18 h and at 24 hours postoperative for the quality of analgesia

Secondary Outcomes (5)

• total intraoperative fentanyl consumption

  during the time of the surgical procedure

• 1st time of rescue analgesics

  during the first postoperative 24 hours

• total amount of rescue analgesic consumed

  in the first postoperative 24 hours

• post operative nausea and vomiting

  in the first postoperative 24 hours

• degree of patient and parent satisfaction

  at the end of the first postoperative 24 hours

Study Arms (2)

QLB group, Quadratus Lumborum Block group

ACTIVE COMPARATOR

the patient placed in the lateral decubitus position, the low-frequency convex probe of Sonosite M Turbo ultrasonography was placed in the anterior axillary line midway between subcostal margin and iliac crest to identify the abdominal muscle layers, then the probe was moved to the posterior axillary line to visualize the quadratus lumborum muscle attached to the transverse process of the L4, With the psoas major muscle placed anteriorly, the erector spinae muscle posteriorly, a 22-gauge, 80 mm needle was inserted in-plane into the posterior aspect of QL muscle (between quadratus lumborum and erector spinae muscle), and then 0.5ml/kg of 0.25% levobupivacaine local anesthetic was injected behind the muscle as a bolus dose. The block was performed bilaterally.

Procedure: QLB

TAP block group,Transversus Abdominis Plane Block group

ACTIVE COMPARATOR

patient placed in the supine position, a linear multifrequency 6-13 MHz probe of Sonosite M Turbo ultrasonography was placed posterior to the midaxillary line at the midpoint between the inferior costal margin and the iliac crest, a 22-gauge, 50 mm needle was placed using an in-plane technique between the internal oblique and transversus abdominis muscle then local anesthetic was injected in a bolus dose 0.5ml/kg of 0.25% levobupivacaine, the block was done bilaterally.. after ultrasound Identification of the plane between the internal oblique and transversus abdominis muscle,

Procedure: TAP block

Interventions

QLB PROCEDURE

QLB type 2 approach

QLB group, Quadratus Lumborum Block group

TAP block PROCEDURE

classic TAP block approach

TAP block group,Transversus Abdominis Plane Block group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• parent and patient acceptance,
• Children 7-12 years old,
• kg bodyweight,
• ASA I-II,
• and scheduled for Laparoscopic appendicectomy

You may not qualify if:

• Patients refusing regional anesthesia,
• those with bleeding disorders,
• skin lesion at the needle insertion site,
• sepsis,
• liver disease,
• peritonitis,
• and emergency cases

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (8)

• Gupta V, Yadav SK, Dean E, Vincent P, Walid F, Al Said A. Paediatric laparoscopic orchidopexy as a novel mentorship: Training model. Afr J Paediatr Surg. 2013 Apr-Jun;10(2):117-21. doi: 10.4103/0189-6725.115035.

  PMID: 23860059 BACKGROUND

• Bharti N, Kumar P, Bala I, Gupta V. The efficacy of a novel approach to transversus abdominis plane block for postoperative analgesia after colorectal surgery. Anesth Analg. 2011 Jun;112(6):1504-8. doi: 10.1213/ANE.0b013e3182159bf8. Epub 2011 Apr 5.

  PMID: 21467560 BACKGROUND

• Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

  PMID: 21296242 BACKGROUND

• Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.

  PMID: 24249997 BACKGROUND

• Tupper-Carey DA, Fathil SM, Tan YK, Kan YM, Cheong CY, Siddiqui FJ, Assam PN. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy. Singapore Med J. 2017 Aug;58(8):481-487. doi: 10.11622/smedj.2016068. Epub 2016 Apr 8.

  PMID: 27056207 BACKGROUND

• Murouchi T. Quadratus lumborum block intramuscular approach for pediatric surgery. Acta Anaesthesiol Taiwan. 2016 Dec;54(4):135-136. doi: 10.1016/j.aat.2016.10.003. Epub 2016 Dec 9. No abstract available.

  PMID: 27939905 BACKGROUND

• Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.

  PMID: 23927552 BACKGROUND

• Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

  PMID: 27755488 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Shereen E Abd Ellatif, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

• Fatma M Ahmed, MD

  Anesthesia and Surgical Intensive Care Department, Faculty of medicine, Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: the participants were masked for the type of regional anesthesia given the care provider was blind to the type of the regional block given to the patient and he was asked to assess the visual analogue scale score, first time of rescue analgesia, the total dose of rescue analgesia given and postoperative side effects.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Model Details: 34 patients randomly allocated into two equal groups 17 patients in each group: Quadratus Lumborum Block" QLB group": ultrasound-guided QLB type 2 with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients. and Transversus Abdominis Plane Block group (TAP block): ultrasound-guided TAP block with 0.5ml/kg of 0.25% levobupivacaine local anesthetic was done to patients.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 24, 2019
• Study Start: October 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: the IPD and any additional supporting information will become available starting 6 months after publication
• Access Criteria: by contacting the study director

Locations

EG (1)