Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
Primary Purpose
Acute Pain, Regional Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
regional analgesia with cryolesia
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring nuss procedure
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic NUSS technique
- aged 10 years or above 10 up to 18
- informed consent signed for cryoanalgesia informed consent signed for regional analgesia
Exclusion Criteria:
- Age of 9 years or below
- Refuse to receive cryoanalgesia or regional analgesia as primary pain relief
- Any contraindication to cryoanalgesia
- Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements
Sites / Locations
- Pomeranian Medical UniversityRecruiting
- Pomeranian Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
intervention
Arm Description
intraoperative cryoanalgesia of intercostal nerves with multimodal analgesia
regional analgesia (ESP block) with intraoperative cryoanalgesia of intercostal nerves and multimodal analgesia
Outcomes
Primary Outcome Measures
The worse pain
Maximal pain within first 24 hours after operation, Numeric pain score. Range from 0 to 10.
Secondary Outcome Measures
LAST (Local anesthetic systemic toxicity)
No score exists. Assesment of clinical features: sensory and visual changes, muscular activation, seizure activity, new rhythm disturbances.
Full Information
NCT ID
NCT05589246
First Posted
October 8, 2022
Last Updated
October 18, 2022
Sponsor
Pomeranian Medical University Szczecin
1. Study Identification
Unique Protocol Identification Number
NCT05589246
Brief Title
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
Official Title
Regional Analgesia in Combination With Intraoperative Cryoanalgesia Are the Essential Parts of Enhanced Recovery Protocol in the Minimally Invasive Modyfied Nuss Procedure of Children With Funnel Chest Deformation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
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
No
5. Study Description
Brief Summary
Funnel chest deformation is a painful procedure, which requires high doses and long time used of opioids. It makes difficult introduction of ERAS protocol. Intraoperative cryolesia of intercostal nerves serves great relief of pain after this procedures. However ablation of the nerves needs 12-24 hours to achieve effects. During this time the high doses of opioids are needed. It causes side effects (sedation makes rehabilitation difficult). On the other hand, percutaneus cryoablation performed 12-24 hours before Nuss procedure needs repeated general anaesthesia. The investigators hypothesed that regional analgesia (erector spine plain block) performed just before intraopertive cryolesia may cover time to full cryolesia effect.
Detailed Description
Severe pain in the post-Nuss procedure needs the use of many analgesic drugs, including opioids. It may cause adverse side effects and difficulties with rehabilitation. Moreover, it increases the risk of complications and prolonged hospitalisation. Cryoanalgesia as a part of multimodal analgesia offers better analgesia than single regional techiques with drugs and fasilitate introduction of the enhanced recovery after surgery (ERAS) protocol. However ablation of the nerves needs 12-24 hours to achieve effects. Regional analgesia (erector spine plain block) performed just before intraopertive cryolesia may cover time to full cryolesia effect.
This Before - After Study is a single institution pilot study designed to compare intraoperative cryolesia alone (control group) with the intervention group (cryolesia and bilateral erector spine plane block). It is designed for better management of acute pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method. Control group received standard care with cryolesia using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited) and multimodal analgesia according the current guidelines. The intervention group received all of the above and regional analgesia (erector spine plain block, ESP block).
The aims of the study were the assessment the effectiveness of ESP block before full action of intraoperative cryoanalgesia as a method of acute pain control, safety of the method.
The results were compared in terms of demographics, pain levels, side effects of the pain relief medications in the postoperative period and lenght of hospitalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Regional Anesthesia
Keywords
nuss procedure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
intraoperative cryoanalgesia of intercostal nerves with multimodal analgesia
Arm Title
intervention
Arm Type
Experimental
Arm Description
regional analgesia (ESP block) with intraoperative cryoanalgesia of intercostal nerves and multimodal analgesia
Intervention Type
Device
Intervention Name(s)
regional analgesia with cryolesia
Intervention Description
The regional analgesia (erector spine plane block) will be added to intraoperative cryolesia of intercostal nerves
Primary Outcome Measure Information:
Title
The worse pain
Description
Maximal pain within first 24 hours after operation, Numeric pain score. Range from 0 to 10.
Time Frame
within first 24 hours after operation
Secondary Outcome Measure Information:
Title
LAST (Local anesthetic systemic toxicity)
Description
No score exists. Assesment of clinical features: sensory and visual changes, muscular activation, seizure activity, new rhythm disturbances.
Time Frame
within first 24 hours after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic NUSS technique
aged 10 years or above 10 up to 18
informed consent signed for cryoanalgesia informed consent signed for regional analgesia
Exclusion Criteria:
Age of 9 years or below
Refuse to receive cryoanalgesia or regional analgesia as primary pain relief
Any contraindication to cryoanalgesia
Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements
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
Sławomir Zacha, MD PhD
Phone
513100813
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
Principal Investigator
Facility Information:
Facility Name
Pomeranian Medical University
City
Szczecin
ZIP/Postal Code
70-204
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jowita Biernawska, MD PhD
Phone
+48501337073
Email
lisienko@wp.pl
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, MD PhD
Phone
+48501337073
Email
lisienko@wp.pl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
after contact with the principal investigator
Learn more about this trial
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
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