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Sub-Paraspinal Block in Nuss Patients. A Pilot Project

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ClinicalTrials.gov Identifier: NCT02169297
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Nemours Children's Clinic

Tracking Information
First Submitted Date  ICMJE June 19, 2014
First Posted Date  ICMJE June 23, 2014
Last Update Posted Date June 23, 2014
Study Start Date  ICMJE November 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Narcotic Requirement [ Time Frame: 48 hours post intervention ]
Narcotic requirement was recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Pain Scores [ Time Frame: 48 hours ]
Pain scores (FLACC/FACES) were recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sub-Paraspinal Block in Nuss Patients. A Pilot Project
Official Title  ICMJE A Novel Ultrasound-Guided Extrathoracic Sub-Paraspinal Block Utilizing Multi- Perforated Soaker Catheters for Control of Perioperative Pain: A Prospective Randomized Pilot Project in Nuss Patients
Brief 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.
Detailed Description

This study underwent initial peer review by the Biomedical Research Committee at Nemours and was awarded internal funding by the Nemours Funding committee. Scientific progress review was conducted annually and was the basis for subsequent year funding.

Ten eligible patients were recruited and allocated into one of two groups according to a computer generated random allocation table: five patients allocated to the treatment group received bilateral ultrasound-guided placement of multi-perforated soaker catheter at sub-paraspinal location and an intravenous PCA post-operatively; five patients allocated to the control group had two sham multi-perforated soaker catheters taped to their back and received intravenous PCA post-operatively. In the treatment group, 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. A 7.5 inch On-Qr multi-perforated catheter was placed via each introducer for patients under 5'7'' (170.18 cm) and a 10" (25.4 cm) catheters was placed for those over 5'7" (170.18 cm). An infusion of ropivacaine 0.2% was started immediately after catheter placement 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]). Maximum total ropivacaine infusion rate was limited to 0.5 mg/kg/hr to avoid toxicity. The local anesthetic infusion was stopped on post-operative day number 3 and the catheters removed.

Catheters were dressed in a way that concealed insertion sites and therefore precluded pain observers from determining group assignment while the pumps appeared to be infusing to blinded viewers. The peri-operative anesthetic and surgical approach were standardized for this study. A single anesthesiologist and surgeon were responsible for the recruitment, anesthesia provision, surgical technique, and multi-perforated soaker catheters insertion. Post-operative pain management was carried out by a group of blinded anesthesiologists according to the post-operative protocol. Three recovery room nurses, six floor nurses and three physical therapists were selected to limit inter observer variability and educated to the post-operative expectations and consistent use of the pain and functional independent measure (FIM) scoring in this patient population. With the exception of the primary investigators, all other personnel were blinded to the patient's group assignment.

The outcomes were evaluated based on the total amount of narcotic per kilogram required, pain scores and functional performance measures derived by physical therapists.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pectus Excavatum
  • Pain, Postoperative
Intervention  ICMJE
  • 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
    Other Name: Patient-Controlled Analgesia
Study Arms  ICMJE
  • Experimental: Ultrasound-Guided Sub-Paraspinal Block
    Patients allocated to the treatment group received bilateral ultrasound-guided placement of multi-perforated soaker catheter at sub-paraspinal location and an intravenous PCA post-operatively
    Interventions:
    • Procedure: Ultrasound-guided Sub-Paraspinal Block
    • Procedure: PCA only
  • Placebo Comparator: PCA only
    Patients allocated to the control group had two sham multi-perforated soaker catheters taped to their back and received intravenous PCA post-operatively
    Intervention: Procedure: PCA only
Publications * Truitt MS, Mooty RC, Amos J, Lorenzo M, Mangram A, Dunn E. Out with the old, in with the new: a novel approach to treating pain associated with rib fractures. World J Surg. 2010 Oct;34(10):2359-62. doi: 10.1007/s00268-010-0651-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2014)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children undergoing the Nuss procedure were considered for the study and were approached during their preoperative anesthesia evaluation.

Exclusion Criteria:

  • Contraindication to the study medications
  • Preexisting chronic pain disorder.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169297
Other Study ID Numbers  ICMJE 16-10841-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nemours Children's Clinic
Study Sponsor  ICMJE Nemours Children's Clinic
Collaborators  ICMJE Zimmer Biomet
Investigators  ICMJE
Principal Investigator: Robert B Bryskin, MD Nemours Children's Clinic
PRS Account Nemours Children's Clinic
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP