Postoperative Pain After Pediatric Umbilical Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Hospital Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Harvard Catalyst Pilot Grant
Harvard University
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01015053
First received: November 12, 2009
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Pediatric Postoperative Pain
Procedure: bilateral ultrasound-guided rectus sheath block
Procedure: Wound infiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Pain After Pediatric Umbilical Hernia Repair: a Randomized Clinical Trial of Ultrasound-guided Bilateral Rectus Sheath Blocks Versus Local Anesthetic Infiltration

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: from emergence to 24 hrs post-discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative use of opioids and non-opioids [ Time Frame: from emergence to 24 hrs post-discharge ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regional block
An ultrasound-guided rectus sheath block will be performed by the regional block anesthesiologist in the "regional block" arm.
Procedure: bilateral ultrasound-guided rectus sheath block
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.
Other Name: ropivacaine
Active Comparator: Wound infiltration
Local wound infiltration will be performed by the surgeon in the "wound infiltration" arm.
Procedure: Wound infiltration
Ropivacaine 0.2% 1cc/kg is injected subcutaneously at the site of incision by the surgeon.
Other Name: ropivacaine

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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01015053

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Children's Hospital Boston at Waltham
Waltham, Massachusetts, United States, 02453
Sponsors and Collaborators
Children's Hospital Boston
Harvard Catalyst Pilot Grant
Harvard University
Investigators
Principal Investigator: Catherine Chen, MD, MPH Children's Hospital Boston
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Chen MD, MPH, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01015053     History of Changes
Other Study ID Numbers: 09-08-0398
Study First Received: November 12, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
postoperative pain
pediatric
umbilical hernia
ropivacaine
rectus sheath block
regional block
ultrasound-guided regional block
local infiltration
ambulatory surgery

Additional relevant MeSH terms:
Pain, Postoperative
Hernia, Umbilical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014