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Sub-Paraspinal Block in Nuss Patients. A Pilot Project

NCT02169297 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-06-23

No results posted yet for this study

Summary

The purpose of this pilot study was to evaluate effectiveness of a novel regional anesthesia technique developed at the investigators institution, as part of a quality improvement initiative, to assist with multilevel thoracic pain control in post-Nuss procedure patients. The investigators hypothesized that the local anesthetic infusion via bilateral multiperforated soaker catheters placed at extrathoracic sub-paraspinal muscle location under ultrasound guidance would significantly improve pain control, as reflected by the decrease in pain intensity score, reduction in opiate requirement and improvement infunctional rehabilitation measure scores in patients who underwent the Nuss procedure for pectus excavatum repair. However, the goal of this pilot study was not to detect a statistically significant difference in the primary outcomes between control and treatment groups (as the number of study subjects was chosen out of necessity of what could be completed within a specified time period), but to estimate the parameters which allows appropriate power and sample size calculations for a future multi-institutional study.

Conditions

  • Pectus Excavatum
  • Pain, Postoperative

Interventions

PROCEDURE

Ultrasound-guided Sub-Paraspinal Block

Treatment group received bilateral ultrasound-guided placement of multi-perforated soaker catheter at sub-paraspinal location. Catheter position was considered adequate when live ultrasound imaging confirmed placement directly over the rib surface and lateral to the transverse process at the T2-T10 level. An infusion of ropivacaine 0.2% was started via the On-Q infusion system at a rate of 0.25 mg/kg/hour per catheter (maximum of 8 ml/hr catheter \[maximum pump infusion rate\]). The local anesthetic infusion was stopped on post-operative day number 3 and the catheters removed.

PROCEDURE

PCA only

Patients received intravenous PCA post-operatively

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Robert B Bryskin, MD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-11-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02169297 on ClinicalTrials.gov