Acute PainNCT05589246
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
A study testing regional analgesia with cryolesia in people with Acute Pain and Regional Anesthesia, run by Pomeranian Medical University Szczecin at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Acute Pain, Regional Anesthesia
- What is being tested?
- regional analgesia with cryolesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPoland
- Study dates
- 28 Sep 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Pomeranian Medical University
Szczecin, 70-204
Jowita Biernawska, MD PhD, +48501337073, lisienko@wp.pl
- Recruiting
Pomeranian Medical University
Szczecin, 71-252
Sławomir Zacha, MD PhD, +48513100813, sekozacha@gmail.com
Jowita Biernawska, MD PhD, +48501337073, lisienko@wp.pl
About this study
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
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.
Read the 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.
- Conditions
- Acute Pain, Regional Anesthesia
- Being tested
- regional analgesia with cryolesia
- Keywords
- nuss procedure
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional analgesia with cryolesiaDevice
The regional analgesia (erector spine plane block) will be added to intraoperative cryolesia of intercostal nerves
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | intraoperative cryoanalgesia of intercostal nerves with multimodal analgesia |
| intervention | Experimental | regional analgesia (ESP block) with intraoperative cryoanalgesia of intercostal nerves and multimodal analgesia Receives: Device: regional analgesia with cryolesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The worse pain
Maximal pain within first 24 hours after operation, Numeric pain score. Range from 0 to 10.
Measured: within first 24 hours after operation
Secondary outcomes (1)
LAST (Local anesthetic systemic toxicity)
No score exists. Assesment of clinical features: sensory and visual changes, muscular activation, seizure activity, new rhythm disturbances.
Measured: within first 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start28 Sep 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jowita Biernawska, Pomeranian Medical University Szczecin
- Investigators
- Jowita Biernawska, MD PhD, Principal investigator, Pomeranian Medical Universitet Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589246
- Sponsor's protocol ID
- PomeranianMU-KRIO
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: after contact with the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05589246
- Acronym / sponsor ID
- PomeranianMU-KRIO
- Conditions
- Acute Pain, Regional Anesthesia
- Keywords
- nuss procedure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –intraoperative cryoanalgesia of intercostal nerves with multimodal analgesia |
| intervention | Experimental | Device: regional analgesia with cryolesiaregional analgesia (ESP block) with intraoperative cryoanalgesia of intercostal nerves and multimodal analgesia |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regional analgesia with cryolesiaThe regional analgesia (erector spine plane block) will be added to intraoperative cryolesia of intercostal nerves | Device | intervention |
Primary outcome
The worse pain
Time frame: within first 24 hours after operation
Maximal pain within first 24 hours after operation, Numeric pain score. Range from 0 to 10.
1 secondary outcome
LAST (Local anesthetic systemic toxicity)
Time frame: within first 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: Undecided. after contact with the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jowita Biernawska, MD PhD principal investigator
Pomeranian Medical Universitet Szczecin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional analgesia with cryolesia in people with Acute Pain and Regional Anesthesia, run by Pomeranian Medical University Szczecin at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jowita Biernawska, MD PhD (+48501337073, lisienko@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The worse pain (time frame: within first 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.