NCT01015053|CompletedDMC
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Sponsor study identifier
interventional
53
1 country
2
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
November 2011
Actual (reported)The purpose of this study is to compare the use of ultrasound-guided bilateral rectus sheath blocks to local infiltration of anesthetic agent in the surgical wound in a pediatric population of patients undergoing umbilical hernia repair.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 12, 2009
Actual (reported)November 17, 2009
Actual (reported)May 2011
Actual (reported)November 2011
Actual (reported)postoperative pain
from emergence to 24 hrs post-discharge
postoperative use of opioids and non-opioids
from emergence to 24 hrs post-discharge
An ultrasound-guided rectus sheath block will be performed by the regional block anesthesiologist in the "regional block" arm.
Local wound infiltration will be performed by the surgeon in the "wound infiltration" arm.
Ultrasound is used to guide the deposition of Ropivacaine 0.2% 1cc/kg in the posterior sheath of the rectus muscle containing the peripheral nerves that innervate the abdomen.
Ropivacaine 0.2% 1cc/kg is injected subcutaneously at the site of incision by the surgeon.
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Children's Hospital Boston at Waltham
Waltham, Massachusetts, 02453, United States
Jha AK, Orav EJ, Zheng J, Epstein AM. Patients' perception of hospital care in the United States. N Engl J Med. 2008 Oct 30;359(18):1921-31. doi: 10.1056/NEJMsa0804116.
Chan VW, Peng PW, Kaszas Z, Middleton WJ, Muni R, Anastakis DG, Graham BA. A comparative study of general anesthesia, intravenous regional anesthesia, and axillary block for outpatient hand surgery: clinical outcome and cost analysis. Anesth Analg. 2001 Nov;93(5):1181-4. doi: 10.1097/00000539-200111000-00025.
Catherine Chen, MD, MPH
Boston Children's Hospital
53 participants (actual enrollment reported by the registry).
First Submitted
November 12, 2009
First Posted
November 17, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
de Jose Maria B, Gotzens V, Mabrok M. Ultrasound-guided umbilical nerve block in children: a brief description of a new approach. Paediatr Anaesth. 2007 Jan;17(1):44-50. doi: 10.1111/j.1460-9592.2006.02025.x.
Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner SC, Wanzel O, Kapral S. Ultrasonography-guided rectus sheath block in paediatric anaesthesia--a new approach to an old technique. Br J Anaesth. 2006 Aug;97(2):244-9. doi: 10.1093/bja/ael143. Epub 2006 Jun 23.
Dingeman RS, Barus LM, Chung HK, Clendenin DJ, Lee CS, Tracy S, Johnson VM, Dennett KV, Zurakowski D, Chen C. Ultrasonography-guided bilateral rectus sheath block vs local anesthetic infiltration after pediatric umbilical hernia repair: a prospective randomized clinical trial. JAMA Surg. 2013 Aug;148(8):707-13. doi: 10.1001/jamasurg.2013.1442.
Primary Completion
May 2011
Actual (reported)Study Completion
November 2011
Actual (reported)Last Updated
September 15, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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