ES Catheter vs Cryoablation After Pectus Surgery
ConditionPectus Excavatum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups:
* Time to achieve short-term physical therapy goals and long-term functional outcomes * Compare immediate and long-term postoperative opioid use * Compare numbness on chest of postoperative day 1 and the return of sensation to baseline * Compare the incidence of neuropathic pain and other complications
Participants will receive surveys for up to 12 months postoperatively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 12 - 21 years
History of pectus excavatum
Scheduled for Nuss procedure
Disqualifiers
Prior pectus repair
Other concomitant surgeries
Chronic pain conditions including Ehlers Danlos Syndrome
Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception of non-English speaking patients could affect the study power
Trial design
Design model
Parallel
Treatments tested in this trial
ES catheter
Procedure/SurgeryES catheter for postoperative pain control
Intercostal nerve cryoablation (INC)
Procedure/SurgeryINC used for postoperative pain control
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: ES CatheterActive comparator 1 intervention
Group B: Intercostal Nerve Cryoablation (INC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Compare time to reach discharge
Comparing physical therapy goals to meet discharge criteria.
Time frame
Day of surgery up tp 10 days post-operativeSecondary outcomes
1
Opioid consumption
Comparing opioid consumption
Time frame
Day of surgery to up to one year2
Numbness on chest
An exam glove with ice will used on the anterior axillary line to obtain a rating of the sensation felt. 0 - no sensation 1. \- lessened sensation 2. \- abnormal/painful sensation 3. \- no sensation
Time frame
Day of surgery and post-operative day 13
Neuropathic pain
Surveys will be used to compare the incidence of neuropathic pain
Time frame
Pre-operative, 6 weeks, 2-3 months, 4-6 months and 10-12 months post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov