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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

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.

Condition or disease Intervention/treatment Phase
Pectus Excavatum Pain, Postoperative Procedure: Ultrasound-guided Sub-Paraspinal Block Procedure: PCA only Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : November 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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
Procedure: PCA only
Patients received intravenous PCA post-operatively
Other Name: Patient-Controlled Analgesia




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169297


Locations
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United States, Florida
Wolfson Children's Hospital, Baptist Medical Center Downtown
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Zimmer Biomet
Investigators
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Principal Investigator: Robert B Bryskin, MD Nemours Children's Clinic
Publications:
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Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT02169297    
Other Study ID Numbers: 16-10841-002
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: May 2014
Keywords provided by Nemours Children's Clinic:
Pain Management
Anesthesia: Nerve Block
Additional relevant MeSH terms:
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Funnel Chest
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities