Cryoanalgesia Aplication Time Optimization During Nuss Procedure
Primary Purpose
Funnel Chest, Excavatum, Pectus
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
shorter cryoanalgesia
Sponsored by
About this trial
This is an interventional treatment trial for Funnel Chest focused on measuring nuss procedure, cryoanalgesia
Eligibility Criteria
Inclusion Criteria: patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique informed concent signed for cryolesia Exclusion Criteria: age 9 years or below refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
Sites / Locations
- Pomeranian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention side
control side
Arm Description
duration of intercostal nerves cryolesia: 1 minute per left nerve
duration of intercostal nerves cryolesia: 2 minute per right nerve
Outcomes
Primary Outcome Measures
The worse pain occurrence during first 24 hours after operation.
numeric pain score, range from 0 to 10
Secondary Outcome Measures
thoracic hypoaesthesia occurrence
cold test assessment (yes / no)
residual wound or chest pain occurrence
the chest or wound chronic pain occurrence
duration of hospitalization
the lengh of the time in days spent in the hospital
Full Information
NCT ID
NCT05831137
First Posted
April 4, 2023
Last Updated
April 25, 2023
Sponsor
Pomeranian Medical University Szczecin
1. Study Identification
Unique Protocol Identification Number
NCT05831137
Brief Title
Cryoanalgesia Aplication Time Optimization During Nuss Procedure
Official Title
The Optimization of the Intercostal Nerves Cryoablation Aplication Time During Nuss Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
July 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pomeranian Medical University Szczecin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study compared standard therapy (multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in subject undergoing minimal invasive modyfied Nuss procedure with thoracoscopy.
Detailed Description
Funnel chest deformation may be a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain.
2 minutes per one intercostal nerve aplication cryoanalgesia as a part of multimodal analgesia is a standard protocol in many countries.
This Prospective Non-Randomized Study is a single institution pilot study designed to compare standard therapy (control side: multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in each patient to address the need for better management of acute and long-term pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method.
All of the patients will receive a standard care according to Polish guidelines: multimodal analgesia with regional analgesia (bilateral erector spine plane block) with cryoanalgesia. The right intercostal nerves will be treated with 2 minutes cryoanalgesia (control side). The left side of the chest (left intercostal nerves) will be treated with 1 minute cryoanalgesia (intervention side).
The intraoperative cryoanalgesia will be performed using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited).
The study will assess the effectiveness of shorter aplication duration time of cryoanalgesia as a method of acute and long-term pain control and safety of the method.
Specific Aim: To determine if, compared with current 2 minutes cryoanalgesia protocol, 1 minute aplication time of cryoanalgesia is effective at the same level when consider pain control and postoperative functioning in each patient.
The results were compared in terms of demographics, right versus left side of the chest pain levels, quality and length of rehabilitation and patient satisfaction using the Quality of Life by modyfied Nuss questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Funnel Chest, Excavatum, Pectus
Keywords
nuss procedure, cryoanalgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In each patient one side of the chest will be treated by standard metod and the second side will be treated with the novel method.
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention side
Arm Type
Experimental
Arm Description
duration of intercostal nerves cryolesia: 1 minute per left nerve
Arm Title
control side
Arm Type
No Intervention
Arm Description
duration of intercostal nerves cryolesia: 2 minute per right nerve
Intervention Type
Procedure
Intervention Name(s)
shorter cryoanalgesia
Intervention Description
duration time of cryoanalgesia
Primary Outcome Measure Information:
Title
The worse pain occurrence during first 24 hours after operation.
Description
numeric pain score, range from 0 to 10
Time Frame
up to 24 hours after operation
Secondary Outcome Measure Information:
Title
thoracic hypoaesthesia occurrence
Description
cold test assessment (yes / no)
Time Frame
up to 24 hours after operation
Title
residual wound or chest pain occurrence
Description
the chest or wound chronic pain occurrence
Time Frame
postoperative months 1,3
Title
duration of hospitalization
Description
the lengh of the time in days spent in the hospital
Time Frame
estimated 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique
informed concent signed for cryolesia
Exclusion Criteria:
age 9 years or below
refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jowita Biernawska, MD PhD
Phone
+48501337073
Email
lisienko@wp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Slawomir Zacha, MD PhD
Phone
+48513100813
Email
sekozacha@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jowita Biernawska, MD PhD
Organizational Affiliation
Pomeranian Medical Universitet Szczecin
Official's Role
Study Director
Facility Information:
Facility Name
Pomeranian Medical University
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sławomir Zacha, MD PhD
Phone
+48513100813
Email
sekozacha@gmail.com
First Name & Middle Initial & Last Name & Degree
Jowita Biernawska, MDPhD
Phone
501337073
Email
lisienko@wp.pl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We invite others researchers to collaboration as multicenter study
IPD Sharing Time Frame
up to 12 months from the beginning of the study
IPD Sharing Access Criteria
by contacy to the Principal Investigator
Citations:
PubMed Identifier
36283847
Citation
Zeineddin S, Goldstein SD, Linton S, DeBoer C, Alayleh A, Ortiz I, Sands L, Kujawa S, Suresh S, Ghomrawi H, Abdullah F. Effectiveness of one minute per level intercostal nerve cryoablation for postoperative analgesia after surgical correction of pectus excavatum. J Pediatr Surg. 2023 Jan;58(1):34-40. doi: 10.1016/j.jpedsurg.2022.09.032. Epub 2022 Sep 26.
Results Reference
result
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Cryoanalgesia Aplication Time Optimization During Nuss Procedure
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