Efficacy Study of Rectus Sheath Block to Control Postoperative Pain

Pain, Postoperative Clinical Trial

— UGRSB  

Official title:

The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115087
• Other study ID #: UGRSB-123
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2014
• Last updated: April 14, 2014
• Start date: September 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2014
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.

Description:

Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• ASA physical status I-II

• 3-15 years of age children

• Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision

Exclusion Criteria:

• ASA physical status III and above

• Parents who did not consider to participate in the study

• Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• ultrasound guided rectus sheath block
the application of rectus sheath block with ultrasound guidance

Drug:
• Morphine

Locations

Country	Name	City	State
Turkey	Department of Anesthesiology, Cukurova University Faculty of Medicine	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the FLACC scale	FLACC scale has been used to measure postoperative pain level in children	Twenty-four hours	Yes