Knee ProsthesisNCT06422585
Comparison of Different Analgesic Nerve Blocks in Total Knee Replacement Surgery
An observational study of Knee Prosthesis and Pain, Procedural, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is: Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Prosthesis, Pain, Procedural
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to Feb 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients meeting the inclusion criteria
Who may be able to join
- Age > 18 y/o
- Total knee replacement elective surgery
- Informed consent
Who cannot join
- Age < 18 y/o
- Surgery with general anesthesia
- Patients with coagulopaties
- Patients in chronic opioid therapy
- Refuse to sign informed consent form
- Unable to sign informed consent form
- Know allergies to medication used for analgesia
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Edificio 3 - Azienda Ospedaliero Universitaria Pisana Cisanello
Pisa, Tuscany, 56124
Serena Ricalzone, MD, 050.997881
About this study
Official title: Comparison of Three Different Analgesic Nerve Blocks in Total Knee Replacement Surgery
The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is:
- Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in.
Researchers will compare the Femoral Nerve Group+IPACK block, the Saphenous Nerve block+IPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery.
Read the detailed description
After adequate venous access is obtained, a light sedation with Midazolam 1-2 mg is administered. The patient will be monitored and a selective spinal anesthesia will be performed. After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic.
Magnesium Solfate 1g and Dexametasone 4mg are administered after the block. If the patient wishes, a propofol continuos infusion may be administered for sedation during the surgery. Before the patient leaves the OR, Ketorolac 30mg will be administered.
Pain control after surgery will be achieved with acetaminophen 1g t.i.d., Ketorolac 30mg on demand, and Morphine solfate if NRS >5 after Ketorolac.
Every 6 hours the patient will be monitored by the anesthesia team. After 24 hours the antalgic effect of the nerve block is reasonably thought to be over, so the follow up is interrupted.
- Conditions
- Knee Prosthesis, Pain, Procedural
- Keywords
- Knee, Post procedural pain, Regional anesthesia
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block + IPACK Block | After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which antalgic Femoral Nerve Block and IPACK Block will be performed. | |
| Saphenous (Adductor Canal) Block + IPACK Block | After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Saphenous and IPACK Block will be performed. | |
| Dual Subsartorial Block | After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Dual Subsartorial Block will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
To compare the analgesic effect at 24 hours, of a nerve block technique compared to others after selective spinal anesthetic is administerd to achieve surgical anesthesia.Evaluate pain for every group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three.
Success of the block was defined as NRS≤3.
Measured: Baseline, every 6 hours for the first 24 hours after surgery
Secondary outcomes (1)
side effect
Monitoring the onset of side effects (nausea/vomiting/hypotension/dizziness/sensitive impareiment) in every group of patients in the first 24 hours every six hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ProsthesisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serena Ricalzone, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Silvia Nardi, MD, Study director, Azienda Ospedaliera Universitaria PisanaAlessandro Cardu, MD, Study chair, Scuola Specializzazione - Università di Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422585
- Sponsor's protocol ID
- PGBLOCK
- Status last verified
- May 2024
- First submitted
- 26 Apr 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Analgesic Nerve Blocks in Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT06422585
- Acronym / sponsor ID
- PGBLOCK
- Conditions
- Knee Prosthesis, Pain, Procedural
- Keywords
- Knee, Post procedural pain, Regional anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 21 May 2024 (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.
The goal of this observational study is to compare the equivalent analgesic efficacy of three regional anesthesia techniques in total knee replacement surgery. The main question it aims to answer is:
- Non inferiority of each technique in relation to the others Participants will receive selective spinal anesthesia and the antalgic nerve block depending on the group they happen to be in.
Researchers will compare the Femoral Nerve Group+IPACK block, the Saphenous Nerve block+IPACK and the Subsartorial Block groups to see if there is any difference in the pain control in the 24 hours after the surgery.
Detailed description
After adequate venous access is obtained, a light sedation with Midazolam 1-2 mg is administered. The patient will be monitored and a selective spinal anesthesia will be performed. After the neuraxial procedure the antalgic block of choice is performed with about 40 mL of long acting local anesthetic.
Magnesium Solfate 1g and Dexametasone 4mg are administered after the block. If the patient wishes, a propofol continuos infusion may be administered for sedation during the surgery. Before the patient leaves the OR, Ketorolac 30mg will be administered.
Pain control after surgery will be achieved with acetaminophen 1g t.i.d., Ketorolac 30mg on demand, and Morphine solfate if NRS >5 after Ketorolac.
Every 6 hours the patient will be monitored by the anesthesia team. After 24 hours the antalgic effect of the nerve block is reasonably thought to be over, so the follow up is interrupted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block + IPACK Block | – | –After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which antalgic Femoral Nerve Block and IPACK Block will be performed. |
| Saphenous (Adductor Canal) Block + IPACK Block | – | –After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Saphenous and IPACK Block will be performed. |
| Dual Subsartorial Block | – | –After adequate venous access has been obtained, spinal anesthesia with Levobupivacaine will be performed. After which Dual Subsartorial Block will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the inclusion criteria
Key inclusion criteria (3 listed)
- Age > 18 y/o
- Total knee replacement elective surgery
- Informed consent
Key exclusion criteria (7 listed)
- Age < 18 y/o
- Surgery with general anesthesia
- Patients with coagulopaties
- Patients in chronic opioid therapy
- Refuse to sign informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NRS
Time frame: Baseline, every 6 hours for the first 24 hours after surgery
To compare the analgesic effect at 24 hours, of a nerve block technique compared to others after selective spinal anesthetic is administerd to achieve surgical anesthesia.Evaluate pain for every group in the first 24 hours post surgery using the Numeric Pain Scale (NRS) assigning a numeric value between zero (no pain) and ten (the worst pain ever felt). Absence of relevant pain is considered a NRS less than three. Success of the block was defined as NRS≤3.
1 secondary outcome
side effect
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Silvia Nardi, MD study director
Azienda Ospedaliera Universitaria Pisana
Alessandro Cardu, MD study chair
Scuola Specializzazione - Università di Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Prosthesis and Pain, Procedural, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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 7 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 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Serena Ricalzone, MD (050.997881, serenaricalzone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Baseline, every 6 hours for the first 24 hours after surgery). 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 May 2024.