Cryoanalgesia vs. Epidural in the Nuss Procedure

NCT ID: NCT02721017

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-09-30

Brief Summary

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.

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.

Conditions

Pectus Excavatum; Funnel Chest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoanalgesia

Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure

Group Type: EXPERIMENTAL

Cryoanalgesia

Intervention Type: DEVICE

Thoracic Epidural

Thoracic epidural (ropivicaine, fentanyl).

Group Type: ACTIVE_COMPARATOR

Thoracic epidural (ropivicaine, fentanyl)

Intervention Type: DRUG

Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.

Interventions

Cryoanalgesia

Intervention Type: DEVICE

Thoracic epidural (ropivicaine, fentanyl)

Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.

Intervention Type: DRUG

Other Intervention Names

AtriCure; cryoprobe; nerve freezing; Epidural

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Padilla, MD

Role: PRINCIPAL_INVESTIGATOR

415-370-2835

Locations

UCSF-Benioff Children's Hospital

San Francisco, California, United States

Countries

United States

References

Graves C, Idowu O, Lee S, Padilla B, Kim S. Intraoperative cryoanalgesia for managing pain after the Nuss procedure. J Pediatr Surg. 2017 Jun;52(6):920-924. doi: 10.1016/j.jpedsurg.2017.03.006. Epub 2017 Mar 16.

Reference Type: BACKGROUND

PMID: 28341230 (View on PubMed)

Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.

Reference Type: RESULT

PMID: 30935731 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R03HD090617-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1P50FD006424-01

Identifier Type: FDA

Identifier Source: secondary_id

View Link

15-18202

Identifier Type: -

Identifier Source: org_study_id