TFPB vs QLB III in Infra-umbilical Pediatric Surgeries

Surgical Procedure, Unspecified Clinical Trial

Official title:

Investigation of the Effects of Transversalis Fascial Plane Block and Quadratus Lumborum Plane Block Applied in Pediatric Infra-umbilical Surgeries on Postoperative Pain and Analgesic Consumption

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671484
• Other study ID #: 2022.205.11.06
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2023
• Source: Namik Kemal University
• Contact: Onur Baran, Asst. Prof.
• Phone: +905393422582
• Email: dronurbaran[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Regional anesthetic techniques; they reduce postoperative morbidity, provide early mobilization and provide great advantages by significantly reducing the need for narcotic analgesics. Regional anesthetic techniques are widely used in our clinic for postoperative analgesia, especially in infants and children. In patients undergoing lower abdominal surgery, postoperative analgesia is usually provided by systemic opioids and neuraxial methods. Complications such as sedation, respiratory depression, itching, nausea, vomiting and possible paraplegia or bleeding of neuraxial methods due to the use of opioids seem to be the biggest disadvantages of these two methods. Transversalis fascial plane (TFP) block is a regional anesthesia technique that provides intraoperative and postoperative analgesia as an alternative to caudal and epidural analgesia, especially in children. Transversalis fascial plane (TFP) block was first described in 2009. TFP block has been shown to be effective as an alternative to epidural analgesia and as part of a multimodal postoperative analgesic approach in lower abdominal and pelvic surgeries in children. Quadratus lumborum block (QLB) is a widely used regional anesthesia technique. It is used in pediatric patients to reduce postoperative pain in supraumbilical or infraumbilical surgeries. As a common result of all approaches, the main effect in quadratus lumborum block is anesthesia of the lateral cutaneous branches. In our center, the investigators have been using both methods, alone or in combination, routinely for a long time, and the investigators aim to compare the two methods in this study. This study consists of comparing two domain blocks known as part of multimodal analgesia.

Description:

Transversalis fascial plane block and quadratus lumborum block are performed under general anesthesia just before the surgical incision, unless there are contraindications for the procedure for every patient scheduled for elective infraumbilical surgery in our center. In our study, patients will be divided into 2 groups and the effectiveness of trunk plan blocks, which are part of multimodal analgesia, will be compared. In the first group there will be patients who underwent transversalis fascial plane block (TFPB) alone, and in the second group there will be patients who underwent type III quadratus lumborum block (QLB). Post-operative pain scores with the Face, Leg, Activity, Cry, Consolability (FLACC) score will be recorded in 2-6-12-24th hours. Between both groups, postoperative analgesia need, time of analgesia need, presence of nausea and vomiting, surgeon and parent satisfaction will be followed up and recorded. All patients are operated under general anesthesia. General anesthesia is maintained with inhalation anesthesia. At the end of the surgery, the patient is awakened and taken to the recovery unit. In this prospective randomized study, the investigators will compare the efficacy of these two blocks, which are part of multimodal analgesia, with postoperative analgesic consumption. Postoperative patient comfort, complications, demographic findings will be used as data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• Parental acceptation to participate and signed written consent

• Aged between 3 and 7

• American Society of Anesthesiologists (ASA) physical score I or II

• Elective infra umbilical surgery

Exclusion Criteria:

• Parental refusal to participate

• Known allergy to local anesthetics

• American Society of Anesthesiologists (ASA) physical score = III

• Coagulopathy

• Hypersensitivity history to the agents to be used

• Local infections

• Known anatomically or systemic disorder

• Known growth and developmental retardation

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Other:
• Transversalis Fascial Plane Block
Patients will receive ultrasound-guided transversalis fascial plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction
• Quadratus Lumborum Plane Block
Patients will receive ultrasound-guided quadratus lumborum plane block with 0,3 ml/kg of bupivacaine 0.25% just after general anesthesia induction

Locations

Country	Name	City	State
Turkey	Tekirdag Namik Kemal University	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
Namik Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Abdelbaser I, Mageed NA, El-Emam EM, ALseoudy MM, Elmorsy MM. Preemptive analgesic efficacy of ultrasound-guided transversalis fascia plane block in children undergoing inguinal herniorrhaphy: a randomized, double-blind, controlled study. Korean J Anesthesiol. 2021 Aug;74(4):325-332. doi: 10.4097/kja.20601. Epub 2020 Dec 14. — View Citation

Ahiskalioglu A, Aydin ME, Doymus O, Yayik AM, Celik EC. Ultrasound guided transversalis fascia plane block for lower abdominal surgery: First pediatric report. J Clin Anesth. 2019 Aug;55:130-131. doi: 10.1016/j.jclinane.2018.12.046. Epub 2019 Jan 15. No abstract available. — View Citation

Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998. — View Citation

Black ND, Malhas L, Jin R, Bhatia A, Chan VWS, Chin KJ. The analgesic efficacy of the transversalis fascia plane block in iliac crest bone graft harvesting: a randomized controlled trial. Korean J Anesthesiol. 2019 Aug;72(4):336-343. doi: 10.4097/kja.d.18.00352. Epub 2019 Mar 19. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of paracetamol consumption	Total dose of paracetamol consumption in the ward	in the first 24 hour postoperatively
Secondary	FLACC score	Postoperative FLACC score in the ward. FLACC score is a 10 point behavioral face, leg, activity, cry, consolability pain scale with a minimum score of 0 and a maximum of 10.	in the first 24 hour postoperatively
Secondary	The 1st time to rescue analgesic need	The time to ask for postoperative analgesia is the time from the end of operation to patient reporting FLACC score = 4.	in the first 24 hour postoperatively
Secondary	Number of postoperative nausea and vomiting	Postoperative nausea and vomiting presence	in the first 24 hour postoperatively
Secondary	Parental satisfaction level	Parental satisfaction level will be evaluated using a five-point Likert scale 5= very satisfied 4= satisfied 3= neutral 2= dissatisfied; 1= very dissatisfied	in the first 24 hour postoperatively