Transversalis Fascia Plane Block in Pediatric Patients

Pain, Postoperative Clinical Trial

Official title:

Effects of Transversalis Fascia Plane Block in Pediatric Patients Undergoing Inguinal Hernia and Orchiopexy Surgeries

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06391528
• Other study ID #: 2024/06-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Zonguldak Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 9 Years

Eligibility

Inclusion Criteria:

• 1-9 years old
• ASA I-II risk group
• Patients whose consent was obtained from their parents with an informed consent form
• Patients who will undergo Inguinal Hernia or Undescended Testi

Exclusion Criteria:

• ASA >2
• History of allergy to local anesthetics
• Known coagulation disorders
• Infection near the entry site
• Body mass index >30
• Those whose parents refused to participate in the study
• Those contraindicated for regional anesthesia
• Those with neurological or neuromuscular disease
• Patients with psychiatric problems
• Patients with a history of opioid use
• Chronic analgesic use
• Operation duration exceeding 2 hours

Related Conditions & MeSH terms

• Pain, Postoperative
• Regional Anesthesia

Intervention

Procedure:
• Transversalis Fascia Plane Block
application of local anesthetic between the transversus abdominis muscle and the transversalis fascia surrounding it from the inside, at the level of the posterior axillary line.

Locations

Country	Name	City	State
Turkey	Zonguldak Bülent Ecevit University medicine faculty	Zonguldak	Kozlu

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain scores	Patients will be evaluated at regular intervals after surgery and their pain will be measured using a FLACC scores.	up to 24 hour after surgery
Secondary	parental satisfaction	asking parents about their satisfaction	during the procedure