Total amount of morphine used in the first 48hrs immediately after surgery
| Group | Value | 95% CI |
|---|---|---|
| Ropivacaine Group | 2.2 | ± 1.8 |
| Normal Saline Group | 3.5 | ± 1.8 |
Last reviewed · How we verify
The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
NA trial testing Ropivacaine wound catheter in Obstruction of Pelviureteric Junction in 15 participants. Terminated before completion.
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 24 April 2009 |
| Primary completion | 6 September 2011 |
| Estimated completion | 6 September 2011 |
| Sites | 2 locations across United States |
Boston Children's Hospital
Adults 3 Months to 14, any sex, with Obstruction of Pelviureteric Junction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total amount of morphine used in the first 48hrs immediately after surgery
| Group | Value | 95% CI |
|---|---|---|
| Ropivacaine Group | 2.2 | ± 1.8 |
| Normal Saline Group | 3.5 | ± 1.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Ropivacaine Group | 1.3 | ± 0.7 |
| Normal Saline Group | 1.9 | ± 1.8 |
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.
No peer-reviewed publications indexed yet for this trial.
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