Postoperative Pain After Pediatric Umbilical Hernia Repair
Primary Purpose
Pediatric Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bilateral ultrasound-guided rectus sheath block
Wound infiltration
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Postoperative Pain focused on measuring postoperative pain, pediatric, umbilical hernia, ropivacaine, rectus sheath block, regional block, ultrasound-guided regional block, local infiltration, ambulatory surgery
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Children's Hospital Boston
- Children's Hospital Boston at Waltham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Regional block
Wound infiltration
Arm Description
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.
Outcomes
Primary Outcome Measures
postoperative pain
Secondary Outcome Measures
postoperative use of opioids and non-opioids
Full Information
NCT ID
NCT01015053
First Posted
November 12, 2009
Last Updated
September 14, 2017
Sponsor
Boston Children's Hospital
Collaborators
Harvard Catalyst Pilot Grant, Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT01015053
Brief Title
Postoperative Pain After Pediatric Umbilical Hernia Repair
Official Title
Postoperative Pain After Pediatric Umbilical Hernia Repair: a Randomized Clinical Trial of Ultrasound-guided Bilateral Rectus Sheath Blocks Versus Local Anesthetic Infiltration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Harvard Catalyst Pilot Grant, Harvard University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Recent studies on adult patients' perceptions of their hospital care have shown that improvements are needed in pain management (Jha, Orav, Zheng, and Epstein). The use of regional anesthetic techniques to block specific peripheral nerves in adult patients has increased in recent decades as an alternative to general anesthesia or to decrease opioid use during and after surgery. Decreased postoperative complications have been observed, with fewer ambulatory patients requiring prolonged recovery room stays and/or costly unplanned hospital admissions (Chan, Peng, Kaszas, Middleton, Muni, Anastakis, and Graham).
Regional anesthetic techniques have not been widely performed in pediatric patients because of the challenge in requiring children to report paresthesias during needle placements. However, pediatric anesthesiologists have recently begun to use ultrasound to identify anatomy, and to guide needle insertion and local anesthetic infiltration, thereby enabling peripheral nerve blocks to be performed safely in children under general anesthesia. Several studies have illustrated that umbilical nerve blocks (Jose Maria, Götzens, and Mabrok) and rectus sheath blocks (Willschke, Bosenberg, Marhofer, Johnston, Kettner, Wanzel, and Kapral) can be used safely and effectively with ultrasound guidance in pediatric outpatient surgery. To date, few studies have explored whether ultrasound-guided regional blocks of the abdomen in children have the desired outcome of reducing postoperative pain and/or decreasing opioid use.
The use of ultrasound to guide the deposition of local anesthetic in the posterior sheath of the rectus muscle containing the peripheral nerves that innervate the abdomen may decrease postoperative pain, opioid and non-opioid analgesic consumption, as well as minimize opioid-related complications. Currently, at Children's Hospital Boston, the most common regimen for pain control after umbilical hernia repair performed under general anesthesia (i.e. standard of care) has been surgeon-administered nonspecific local anesthetic infiltration in the wound at the conclusion of surgery, followed by opioids in the Post-Anesthesia Care Unit and an oral opioid/acetaminophen combination post-discharge. In sporadic cases over the past year, several pediatric surgeons have collaborated with anesthesiologists from the pain service to allow ultrasound-guided bilateral rectus sheath blocks to be performed in patients undergoing umbilical hernia repair, usually prior to the surgical repair, and often concomitantly with surgeon-administered local anesthetic infiltration in the wound. Because of the anecdotal nature of these practices, specific conclusions regarding improvements in post-operative pain or decreased need for post-operative opioid use cannot be drawn. However, anecdotal reports from parents at the time of outpatient post-operative follow-up visits have been encouraging regarding perceived success in achieving adequate post-operative pain control in patients receiving the regional block.
We propose an interdisciplinary, prospective, randomized, single-blinded clinical trial of the use of ultrasound-guided bilateral rectus sheath blocks versus local anesthetic infiltration in a pediatric population of patients undergoing ambulatory umbilical hernia repair at Children's Hospital Boston and Children's Hospital Boston at Waltham.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Postoperative Pain
Keywords
postoperative pain, pediatric, umbilical hernia, ropivacaine, rectus sheath block, regional block, ultrasound-guided regional block, local infiltration, ambulatory surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regional block
Arm Type
Experimental
Arm Description
An ultrasound-guided rectus sheath block will be performed by the regional block anesthesiologist in the "regional block" arm.
Arm Title
Wound infiltration
Arm Type
Active Comparator
Arm Description
Local wound infiltration will be performed by the surgeon in the "wound infiltration" arm.
Intervention Type
Procedure
Intervention Name(s)
bilateral ultrasound-guided rectus sheath block
Other Intervention Name(s)
ropivacaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Wound infiltration
Other Intervention Name(s)
ropivacaine
Intervention Description
Ropivacaine 0.2% 1cc/kg is injected subcutaneously at the site of incision by the surgeon.
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
from emergence to 24 hrs post-discharge
Secondary Outcome Measure Information:
Title
postoperative use of opioids and non-opioids
Time Frame
from emergence to 24 hrs post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Chen, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital Boston at Waltham
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18971493
Citation
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.
Results Reference
background
PubMed Identifier
11682392
Citation
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.
Results Reference
background
PubMed Identifier
17184431
Citation
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.
Results Reference
background
PubMed Identifier
16798774
Citation
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.
Results Reference
background
PubMed Identifier
23760519
Citation
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.
Results Reference
derived
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Postoperative Pain After Pediatric Umbilical Hernia Repair
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