The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
Primary Purpose
Obstruction of Pelviureteric Junction
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine wound catheter
Saline wound catheter
Sponsored by
About this trial
This is an interventional treatment trial for Obstruction of Pelviureteric Junction focused on measuring ropivacaine, pediatric, children, continuous, wound, catheter, infusion, pyeloplasty
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of UPJ stenosis requiring surgical repair
- Ages 3 months to 14 years old
- Guardians give consent and the child gives assent when appropriate
- Both genders
- All racial and ethnic groups
Exclusion Criteria:
- A history of chronic pain and/or use of chronic opioids and other analgesic(s)
- If parents/patients or attending urologist request epidural analgesia or refuse to participate in the study
- Impairment of cognition/neurologic, hepatic, renal, cardiovascular, endocrine, metabolic, and/or coagulation function
- A history of any diagnosis of psychiatric disorders, including bipolar disorders by self-report or by guardian
- A recent history of illicit chemical abuse within one week prior to surgical date
- Participants known to be taking prescribed medications or over-the-counter medications known to affect pain perception such as central nervous system stimulants, hypnotics, sedatives, etc within 24 hours of planned surgical procedure
Sites / Locations
- Children's Hospital Boston
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ropivacaine group
Normal Saline Group
Arm Description
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
Outcomes
Primary Outcome Measures
Morphine
Total amount of morphine used in the first 48hrs immediately after surgery
Secondary Outcome Measures
FLACC Pain Intensity [Faces Legs Activity Cry Consolability] 0-10 Points
Observational FLACC pain intensity assessment tool that consists of observing the Faces Legs Activity Cry Consolability (FLACC) by the bedside nursing staff. This pain assessment tool is validated in non-verbal children and children at 7 years and younger.
Minimum value is 0 and the maximum value is 10, where 0 represents no pain which is a better outcome.
Full Information
NCT ID
NCT00930046
First Posted
June 29, 2009
Last Updated
April 16, 2020
Sponsor
Boston Children's Hospital
Collaborators
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00930046
Brief Title
The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
Official Title
The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine for the Management of Pain After Surgical Correction of Ureteropelvic Junction Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
The institution transitioned from open surgical procedure to Robotic procedure
Study Start Date
April 24, 2009 (Actual)
Primary Completion Date
September 6, 2011 (Actual)
Study Completion Date
September 6, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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 metabolic disease will be excluded. After obtaining consent from a legal guardian, patients will be randomly assigned to the placebo or treatment group. Both groups will receive rescue opioids for postoperative pain management via either patient-controlled analgesia (PCA) or nurse-controlled analgesia (NCA) administration for younger patients. The intraoperative anesthetic management will be standardized in all patients.
The wound catheter (Soaker multi-orifice catheter approved by the FDA) will be placed at the completion of the surgery in the subcutaneous space parallel and proximal to the surgical incision by the surgeon. The Pain Treatment Service will manage postoperative pain with standardized protocols including infusion of ropivacaine via the wound catheter and administration of rescue opioids via PCA/NCA. Patients will be randomly assigned to receive infusions of either ropivacaine or saline via the wound catheters.
Outcome Measures
The primary outcome measure is the total amount of opioids consumed by patients in the treatment group compared to that consumed by the placebo groups, noting the potential opioid-sparing effect in the patients treated with the continuous wound catheters with ropivacaine versus saline in the placebo group. The secondary outcome measures include a composite pain assessment scale (FLACC), that can be used as a self-report or observation scale, incidence of opioid-related incidence of nausea, vomiting, sedation and respiratory depression, time to first feed (as a measure of return of bowel function), transition to oral analgesics, time to first ambulation and time to discharge from the hospital. Finally, any adverse outcomes related to local anesthetic infusion, catheter related infection and technical failure such as catheter occlusion and premature dislodgement will be recorded.
Patient Recruitment
Patients will be identified from the Urology Clinic scheduling office and recruited in the Pre-operative Anesthesia Clinic.
Data Collection
Outcome measure data will be recorded by nurses and physicians who are unaware of the randomization for 48hrs post-operatively. The following outcome measures will be recorded. The total amount of opioids consumed by all patients over the first 48hrs after surgery, The daily total amount and pattern of opioid use via a PCA or NCA pump will be recorded from the electronic medical record. The pain assessment scores and adverse effects of opioids and local anesthetic administration will be recorded by a standardized protocol. Other outcome measures include the incidence of emesis, time to first feed or oral intake, pain intensity assessment by self-report in older children and observation in younger children, and time to discharge.
Statistical Analysis
Power analysis indicated that 48 patients randomized equally to each group (n=24 per group) will provide 80% (alpha= 0.05, beta= 0.20) power to detect a 25% difference in total opioid usage during the first 48 hours postoperatively. Fisher's exact test will be used to compare binomial proportions of nausea/vomiting, sedation, respiratory depression, ileus, and proportion of patients requiring postoperative opioids. In addition, groups will be compared using Kaplan-Meier curves and will be constructed to model time to first oral intake with the log-rank test to compare groups and 95% confidence intervals derived using Greenwood's formula. A Uniform(0,1) random number generator will be used to determine treatment allocation and to minimize any covariate imbalances between the ropivacaine and saline groups. Two-tailed values of p<0.05 will be regarded as statistically significant.
Summary
The investigators anticipate that the simple measure of wound catheter infusion with ropivacaine will demonstrate a significant safe and effective modality of analgesia in the postoperative period. If our results are valid, improved pain modulation with such a simple, low-tech modality of postoperative pain control (a) will require further investigation with a larger patient population including broader categories of surgical procedures to determine the limits of efficacy of such techniques in a particular surgical procedure, (b) may demonstrate statistically and clinically significant decreases in pain and decrease opioid demands, (c) may lessen time for recovery and side effects secondary to opioid use (d) offer significant cost-benefit for in-patient care relative to currently used modalities of epidural analgesia or systemic opioids for the management of postoperative pain in children undergoing UPJ correction and (e) compared to presently used epidural and PCA opioid analgesia, the wound catheter analgesia is expected to be less demanding on nurses and physicians (i.e. Pain Treatment Service), staff time, attention and need for close monitoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstruction of Pelviureteric Junction
Keywords
ropivacaine, pediatric, children, continuous, wound, catheter, infusion, pyeloplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Arm Title
Normal Saline Group
Arm Type
Placebo Comparator
Arm Description
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
Intervention Type
Device
Intervention Name(s)
Ropivacaine wound catheter
Other Intervention Name(s)
ON-Q Catheter
Intervention Description
19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
Intervention Type
Device
Intervention Name(s)
Saline wound catheter
Other Intervention Name(s)
ON-Q Catheter
Intervention Description
19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
Primary Outcome Measure Information:
Title
Morphine
Description
Total amount of morphine used in the first 48hrs immediately after surgery
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
FLACC Pain Intensity [Faces Legs Activity Cry Consolability] 0-10 Points
Description
Observational FLACC pain intensity assessment tool that consists of observing the Faces Legs Activity Cry Consolability (FLACC) by the bedside nursing staff. This pain assessment tool is validated in non-verbal children and children at 7 years and younger.
Minimum value is 0 and the maximum value is 10, where 0 represents no pain which is a better outcome.
Time Frame
48 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of UPJ stenosis requiring surgical repair
Ages 3 months to 14 years old
Guardians give consent and the child gives assent when appropriate
Both genders
All racial and ethnic groups
Exclusion Criteria:
A history of chronic pain and/or use of chronic opioids and other analgesic(s)
If parents/patients or attending urologist request epidural analgesia or refuse to participate in the study
Impairment of cognition/neurologic, hepatic, renal, cardiovascular, endocrine, metabolic, and/or coagulation function
A history of any diagnosis of psychiatric disorders, including bipolar disorders by self-report or by guardian
A recent history of illicit chemical abuse within one week prior to surgical date
Participants known to be taking prescribed medications or over-the-counter medications known to affect pain perception such as central nervous system stimulants, hypnotics, sedatives, etc within 24 hours of planned surgical procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navil Sethna, MD
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
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
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The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
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