Sub-Paraspinal Block in Nuss Patients. A Pilot Project

NCT02169297 | Completed Phase 4 DMC

• 1 other identifier: 16-10841-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum; Pain, Postoperative

Keywords

Pain Management; Anesthesia: Nerve Block

Outcome Measures

Primary Outcomes (1)

• Narcotic Requirement

  Narcotic requirement was recorded in the PACU and at 6 hour intervals through 48 hours from the time of arrival to PACU

  48 hours post intervention

Secondary Outcomes (1)

• Pain Scores

  48 hours

Study Arms (2)

Ultrasound-Guided Sub-Paraspinal Block

EXPERIMENTAL

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; Procedure: PCA only

PCA only

PLACEBO COMPARATOR

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

Interventions

Ultrasound-guided Sub-Paraspinal Block PROCEDURE

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.

Ultrasound-Guided Sub-Paraspinal Block

PCA only PROCEDURE

Patients received intravenous PCA post-operatively

Also known as: Patient-Controlled Analgesia

PCA only; Ultrasound-Guided Sub-Paraspinal Block

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Contraindication to the study medications
• Preexisting chronic pain disorder.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Wolfson Children's Hospital, Baptist Medical Center Downtown

Jacksonville, Florida, 32207, United States

Location

Related Publications (1)

• 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.

  PMID: 20567973 BACKGROUND

MeSH Terms

Conditions

Funnel Chest; Pain, Postoperative; Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Robert B Bryskin, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: June 23, 2014

Record last verified: 2014-05

Locations

US (1)