Ultrasound-guided Rectus Sheath Block In Children

NCT02291705 | Completed Phase 4

• 1 other identifier: USG12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.

Conditions

Postoperative Pain

Keywords

Ultrasound, rectus sheath block, children, inguinal hernia

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  postoperative 24 hours

Study Arms (2)

rectus sheath block

EXPERIMENTAL

rectus sheath block

Procedure: rectus sheath block

tramadol

ACTIVE COMPARATOR

tramadol control group

Drug: Tramadol

Interventions

rectus sheath block PROCEDURE

ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine

rectus sheath block

Tramadol DRUG

tramadol 1 mg/kg iv

tramadol

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The children aged 2-7 years scheduled for inguinal hernia repair

You may not qualify if:

• American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (3)

• Breschan C, Jost R, Stettner H, Feigl G, Semmelrock S, Graf G, Likar R. Ultrasound-guided rectus sheath block for pyloromyotomy in infants: a retrospective analysis of a case series. Paediatr Anaesth. 2013 Dec;23(12):1199-204. doi: 10.1111/pan.12267. Epub 2013 Sep 25.

  PMID: 24112798 BACKGROUND

• Flack SH, Martin LD, Walker BJ, Bosenberg AT, Helmers LD, Goldin AB, Haberkern CM. Ultrasound-guided rectus sheath block or wound infiltration in children: a randomized blinded study of analgesia and bupivacaine absorption. Paediatr Anaesth. 2014 Sep;24(9):968-73. doi: 10.1111/pan.12438. Epub 2014 May 22.

  PMID: 24853314 BACKGROUND

• Alsaeed AH, Thallaj A, Khalil N, Almutaq N, Aljazaeri A. Ultrasound-guided rectus sheath block in children with umbilical hernia: Case series. Saudi J Anaesth. 2013 Oct;7(4):432-5. doi: 10.4103/1658-354X.121079.

  PMID: 24348296 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Interventions

Tramadol

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)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• dilek ozcengiz, MD

  CUKUROVA UNİVERSİTY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant Professor

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

TU (1)