Cryoanalgesia vs. Epidural in the Nuss Procedure

May 3, 2021 updated by: University of California, San Francisco

Pain Control in the Nuss Procedure: A Prospective, Randomized Trial of Cryoanalgesia vs. Thoracic Epidural

The purpose of this study is to determine whether cryoanalgesia provides better pain control for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pain control is a major challenge for physicians, who must ensure appropriate and effective pain control for their patients, while remaining mindful of the many negative effects of opioid dependence and addiction. Nowhere is there a more pressing need than in children and young adults, who are at high risk for drug abuse, and in post-operative care, since post-operative opioid use can be a starting point for long-term pain issues. Postoperative pain control in the Nuss procedure, minimally invasive repair of the congenital chest wall deformity known as pectus excavatum, remains a significant problem for the 3000 patients who undergo this procedure each year, mostly adolescents and young adults. Many multimodal analgesic regimens have been tried, but optimal treatment remains unknown.

This study will test a novel and promising strategy of using intra-operative cryoanalgesia during the Nuss procedure. Cryoanalgesia is the localized, temporary freezing of peripheral nerves, which is performed at the time of the Nuss procedure. The study is a 20-subject prospective, randomized pilot trial comparing cryoanalgesia to thoracic epidural analgesia for post-operative pain control in patients undergoing the Nuss procedure. Subjects will be recruited from patients already scheduled for a Nuss procedure at our institution, and will undergo 1:1 randomization to either cryoanalgesia or thoracic epidural analgesia for perioperative pain control. During their hospitalization, patients' opiate usage will be prospectively recorded, and pain will be assessed twice per day. Upon discharge, patients will maintain a log of their opiate use, and will return to clinic at 2 weeks, 1 month, 3 months, and 1 year after Nuss procedure for post-operative assessment. Primary outcome is length of perioperative hospitalization, an objective measure that synthesizes many different aspects of a procedure and its subsequent post-operative course, including pain control. Secondary outcomes are post-operative narcotic usage and direct cost of perioperative hospitalization. Side effects of both interventions will also be assessed.

This will be the first systematic investigation of cryoanalgesia for local nerve block in a thoracoscopic procedure, and the first study involving its use in adolescents and young adults. The results will have direct application for those undergoing the Nuss procedure to repair pectus excavatum. Investigators will also delineate a reproducible protocol for delivering cryoanalgesia thoracoscopically, to ensure others can safely and effectively use this method if it proves beneficial. Although the focus is on the small subset of patients who undergo the Nuss procedure, if a standardized approach to cryoanalgesia delivery in a thoracoscopic procedure has a positive effect on patient outcomes and cost of hospitalization, the technique could be applied to a variety of surgical procedures, as well as for other neuropathic pain.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF-Benioff Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • scheduled for Nuss procedure for pectus excavatum correction
  • at least 13 years old at the time of the procedure

Exclusion Criteria:

  • age less than 13 years at time of procedure
  • use of pain medication prior to procedure
  • pectus carinatum, Poland's syndrome, or any chest wall anomaly other than pectus excavatum
  • previous repair of pectus excavatum by any technique
  • previous thoracic surgery
  • congenital heart disease
  • bleeding dyscrasia
  • major anesthetic risk factors or history of previous problem with anesthesia
  • pregnancy
  • inability to communicate in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoanalgesia
Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure
Device: Cryoanalgesia
Other Names:
  • AtriCure
  • cryoprobe
  • nerve freezing
Active Comparator: Thoracic Epidural
Thoracic epidural (ropivicaine, fentanyl).
Drug: Thoracic epidural (ropivicaine, fentanyl)
Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
Other Names:
  • Epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospitalization
Time Frame: estimated one week or less
the length of the patient's in-hospital stay following admission for Nuss procedure
estimated one week or less

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Usage
Time Frame: Post Operative Hospital Stay
Inpatient narcotic usage
Post Operative Hospital Stay
Mean Neuropathic Pain Score at One Year
Time Frame: one year
Neuropathic specific pain (described as "burning", "electrical" or "tingling" sensations) was assessed by study questionnaire via numerical pain scale (1 to 10, with 10 representing a maximum score, or worst pain possible).
one year
Cost Analysis
Time Frame: estimated one week
cost analysis of initial hospitalization following Nuss procedure
estimated one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Food and Drug Administration (FDA)

Investigators

  • Principal Investigator: Benjamin Padilla, MD, 415-370-2835

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

August 28, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-18202
  • 1R03HD090617-01 (U.S. NIH Grant/Contract)
  • 1P50FD006424-01 (U.S. FDA Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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