Sub-Paraspinal Block in Nuss Patients. A Pilot Project
Primary Purpose
Pectus Excavatum, Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-guided Sub-Paraspinal Block
PCA only
Sponsored by
About this trial
This is an interventional supportive care trial for Pectus Excavatum focused on measuring Pain Management, Anesthesia: Nerve Block
Eligibility Criteria
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.
Sites / Locations
- Wolfson Children's Hospital, Baptist Medical Center Downtown
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ultrasound-Guided Sub-Paraspinal Block
PCA only
Arm Description
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
Patients allocated to the control group had two sham multi-perforated soaker catheters taped to their back and received intravenous PCA post-operatively
Outcomes
Primary Outcome Measures
Narcotic Requirement
Narcotic requirement was recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU
Secondary Outcome Measures
Pain Scores
Pain scores (FLACC/FACES) were recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU
Full Information
NCT ID
NCT02169297
First Posted
June 19, 2014
Last Updated
June 20, 2014
Sponsor
Nemours Children's Clinic
Collaborators
Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT02169297
Brief Title
Sub-Paraspinal Block in Nuss Patients. A Pilot Project
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic
Collaborators
Zimmer Biomet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum, Pain, Postoperative
Keywords
Pain Management, Anesthesia: Nerve Block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound-Guided Sub-Paraspinal Block
Arm Type
Experimental
Arm Description
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
Arm Title
PCA only
Arm Type
Placebo Comparator
Arm Description
Patients allocated to the control group had two sham multi-perforated soaker catheters taped to their back and received intravenous PCA post-operatively
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Sub-Paraspinal Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PCA only
Other Intervention Name(s)
Patient-Controlled Analgesia
Intervention Description
Patients received intravenous PCA post-operatively
Primary Outcome Measure Information:
Title
Narcotic Requirement
Description
Narcotic requirement was recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU
Time Frame
48 hours post intervention
Secondary Outcome Measure Information:
Title
Pain Scores
Description
Pain scores (FLACC/FACES) were recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Bryskin, MD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Children's Hospital, Baptist Medical Center Downtown
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20567973
Citation
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.
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Sub-Paraspinal Block in Nuss Patients. A Pilot Project
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