Clinical Trial: The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine for the Management of Pain After Surgical Correction of Ureteropelvic Junction Stenosis
Brief Summary: The investigators propose a prospective blinded randomized control trial (RCT) to assess the efficacy and safety of a simple method of continuous infusion of a local anesthetic, ropivacaine, via a surgical wound to control pain after ureteropelvic junction (UPJ) stenosis correction in children during the first 48 hrs after surgery. The investigators hypothesize that this technique will provide greater pain relief post-operatively and reduce the need for systemic opioid use along with a reduction in associated side effects of such analgesics.
Detailed Summary:
The investigators hypothesize that continuous infusion of local anesthetic via a wound catheter would improve postoperative pain control after UPJ correction and diminish the adverse effects associated with current use of opioids, administered via epidural or systemic route, for the management of postoperative pain. The expected benefits from wound catheter infusion are reduction in postoperative opioids requirement thereby diminishing the associated side effects of sedation, respiratory depression, nausea, vomiting, and ileus which occur at an average rate of 50% in children and adolescents based on recent meta-analysis. It may also facilitate early oral intake, ambulation and early discharge from the hospital.
The current use of epidural indwelling catheters for analgesia is associated with 20-25% technical failure rate from catheter misplacement, occlusion, disconnect or dislodgement, premature discontinuation of analgesia due to opioid-related side effects, requires bladder catheterization, and local anesthetic induced weakness in the lower extremities that usually delays ambulation. The dose of local anesthetics infused via the epidural route is much larger than proposed via wound catheters and carries greater risks of systemic toxicity compared to infusion doses anticipated via wound catheter infusion. In addition, the use of opioids such as morphine or hydromorphone via the epidural indwelling catheters produce adverse effects similar to that of systemic opioids and require electronic and close nursing monitoring.
Study Design
The study will include patients, male and female, between the ages of 3 months to 14 years of all ethnic and race groups. Patients with a history of clinically significant cardiovascular, pulmonary, hepatic, renal, neurologic, psychiatric or me
Sponsor: Boston Children’s Hospital
Current Primary Outcome: Total amount of opioid used in the first 48hrs immediately after surgery [ Time Frame: 48 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Assessing pain scale scores (FLACC for patients <7 y.o., NRS for patients >7 y.o. and VAS for guardians), incidences of side effects all in the first 48hrs post-operatively. Finally assessing time to discharge home. [ Time Frame: 48 hours ]
Original Secondary Outcome: Same as current
Information By: Boston Children’s Hospital
Dates:
Date Received: June 29, 2009
Date Started: May 2009
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017
