Postoperative Pain After Pediatric Umbilical Hernia Repair
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|ClinicalTrials.gov Identifier: NCT01015053|
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : September 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Postoperative Pain||Procedure: bilateral ultrasound-guided rectus sheath block Procedure: Wound infiltration||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 Start Date :||November 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||November 2011|
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
- postoperative pain [ Time Frame: from emergence to 24 hrs post-discharge ]
- postoperative use of opioids and non-opioids [ Time Frame: from emergence to 24 hrs post-discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01015053
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|Children's Hospital Boston at Waltham|
|Waltham, Massachusetts, United States, 02453|
|Principal Investigator:||Catherine Chen, MD, MPH||Boston Children’s Hospital|