Ultrasound-guided Rectus Sheath Block In Children

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02291705
• Other study ID #: USG12
• Status: Completed
• Phase: Phase 4
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: May 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated.

Primary end point was pain score using FLACC scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Drug:
• Tramadol
tramadol 1 mg/kg iv

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores		postoperative 24 hours