Cryoanalgesia vs. Epidural in the Nuss Procedure

Pectus Excavatum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721017
• Other study ID #: 15-18202
• Secondary ID: 1R03HD090617-011
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: September 2018

Study information

• Verified date: May 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

Device:
• Cryoanalgesia

Drug:
• Thoracic epidural (ropivicaine, fentanyl)
Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.

Locations

Country	Name	City	State
United States	UCSF-Benioff Children's Hospital	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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):2250-22 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospitalization	the length of the patient's in-hospital stay following admission for Nuss procedure	estimated one week or less
Secondary	Narcotic Usage	Inpatient narcotic usage	Post Operative Hospital Stay
Secondary	Mean Neuropathic Pain Score at 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
Secondary	Cost Analysis	cost analysis of initial hospitalization following Nuss procedure	estimated one week