The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine

NCT ID: NCT00930046

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-24
• Study Completion Date: 2011-09-06

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.

Conditions

Obstruction of Pelviureteric Junction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ropivacaine group

Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery

Group Type: ACTIVE_COMPARATOR

Ropivacaine wound catheter

Intervention Type: DEVICE

19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.

Normal Saline Group

Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.

Group Type: PLACEBO_COMPARATOR

Saline wound catheter

Intervention Type: DEVICE

19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure

Interventions

Ropivacaine wound catheter

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

Saline wound catheter

19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure

Intervention Type: DEVICE

Other Intervention Names

ON-Q Catheter; ON-Q Catheter

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Navil Sethna

Senior Associate in Perioperative Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Navil Sethna, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Children's Hospital Boston

Boston, Massachusetts, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

08-11-0506

Identifier Type: -

Identifier Source: org_study_id