Postoperative Pain After Pediatric Umbilical Hernia Repair
1 other identifier
interventional
53
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2009
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 12, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedSeptember 15, 2017
September 1, 2017
1.5 years
November 12, 2009
September 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative pain
from emergence to 24 hrs post-discharge
Secondary Outcomes (1)
postoperative use of opioids and non-opioids
from emergence to 24 hrs post-discharge
Study Arms (2)
Regional block
EXPERIMENTALAn ultrasound-guided rectus sheath block will be performed by the regional block anesthesiologist in the "regional block" arm.
Wound infiltration
ACTIVE COMPARATORLocal wound infiltration will be performed by the surgeon in the "wound infiltration" arm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Any patient who is 3 to 12 years of age
- Any patient undergoing outpatient umbilical hernia repair
- Any patient capable of expressing pain using the Faces Pain Rating Scale
- Patient has provided assent (if age 10 or older)
- Parents/guardians have provided informed consent
You may not qualify if:
- Any patient classified as ASA III, IV, or V by the American Society of Anesthesiologists
- Any patient with a history of Complex Regional Pain Syndrome
- Any patient with a history of chronic analgesic use
- Any patient who has used an analgesic including opioids, acetaminophen, and/or NSAID's within 24 hours prior to surgery
- Wards of the state
- Any patient with an incarcerated umbilical hernia requiring emergent surgery
- Any patient who does not speak English or Spanish
- Any patient whose primary caregiver does not speak English or Spanish
- Any patient who cannot express pain using the Faces Pain Rating Scale due to a disability
- Any patient whose primary caregiver is unable to comply with home instructions due to a disability
- Any patient less than 3 years of age or greater than 12 years of age
- Any patient with renal insufficiency
- Any patient with a bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Children's Hospitallead
- Harvard Catalyst Pilot Grantcollaborator
- Harvard Universitycollaborator
Study Sites (2)
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Children's Hospital Boston at Waltham
Waltham, Massachusetts, 02453, United States
Related Publications (5)
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.
PMID: 18971493BACKGROUNDChan 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.
PMID: 11682392BACKGROUNDde 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.
PMID: 17184431BACKGROUNDWillschke 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.
PMID: 16798774BACKGROUNDDingeman 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.
PMID: 23760519DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Chen, MD, MPH
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Pediatric Surgeon
Study Record Dates
First Submitted
November 12, 2009
First Posted
November 17, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2011
Study Completion
November 1, 2011
Last Updated
September 15, 2017
Record last verified: 2017-09