Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2022
CompletedFirst Submitted
Initial submission to the registry
October 8, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 21, 2022
October 1, 2022
1 month
October 8, 2022
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The worse pain
Maximal pain within first 24 hours after operation, Numeric pain score. Range from 0 to 10.
within first 24 hours after operation
Secondary Outcomes (1)
LAST (Local anesthetic systemic toxicity)
within first 24 hours after operation
Study Arms (2)
control
NO INTERVENTIONintraoperative cryoanalgesia of intercostal nerves with multimodal analgesia
intervention
EXPERIMENTALregional analgesia (ESP block) with intraoperative cryoanalgesia of intercostal nerves and multimodal analgesia
Interventions
The regional analgesia (erector spine plane block) will be added to intraoperative cryolesia of intercostal nerves
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pomeranian Medical University
Szczecin, 70-204, Poland
Pomeranian Medical University
Szczecin, 71-252, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jowita Biernawska, MD PhD
Pomeranian Medical Universitet Szczecin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 8, 2022
First Posted
October 21, 2022
Study Start
September 28, 2022
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
October 21, 2022
Record last verified: 2022-10