Knee Replacement SurgeryNCT06382285
The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement
A study testing Continues peripheral block in people with Knee Replacement Surgery, run by Assaf-Harofeh Medical Center.
Trial summary
The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Replacement Surgery
- What is being tested?
- Continues peripheral block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 31 Jan 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male patients between the ages of 18 and 80 who have signed an informed consent form.
- ASA is less than 3
- Spinal anesthesia
Who cannot join
- Patients with sensitivity to the anesthetic.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of a Prolonged Peripheral Nerve Block (Utilazing Continuous Adductor Canal Block on the Level of Pain After a Knee Replacement Surgery
The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery
Read the detailed description
Knee replacement surgery is one of the common orthopedic surgeries for the treatment of chronic knee pain. The period after knee replacement surgery is accompanied by moderate to severe pain that affects the patient's ability to quickly return to function. Peripheral nerve blockers and analgesia of different types, administered as part of the anesthesia process, are optimal in controlling pain after surgery. After the surgery, the patients are admitted in the orthopedic inpatient department for 2-3 days on average after surgery for follow-up and early physical therapy necessary to achieve good results and return the patient to full function as soon as possible. The level of pain greatly affects the success rate of the patient's rehabilitation. Thus, since the duration of peripheral nerve block activity does not exceed 8-16 hours on average, it is suggested to treat the patients with a prolonged peripheral nerve block (utilizing continuous adductor canal block) for 24 hours after surgery.
- Conditions
- Knee Replacement Surgery
- Being tested
- Continues peripheral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continues peripheral blockDrug
Also called Treatment group
ropivacaine (Naropin) 0.2% according to a protocol 8-10 cc per hour up to 24 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | ropivacaine (Naropin) 0.2% according to a protocol 8-10 cc per hour up to 24 hours after the surgery Receives: Drug: Continues peripheral block |
| Control group | Placebo comparator | Saline according to a protocol 8-10 cc per hour up to 24 hours after the surgery Receives: Drug: Continues peripheral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Documentation of pain level during the hospitalization days every 12 hours (on a scale of 1-10)
Measured: during hospitalization (1-2 days)
Analgesic use
Documentation of pain level during the hospitalization days every 12 hours (on a scale of 1-10).
Documentation of analgesic administration in hospitalization.
Measured: during hospitalization (1-2 days)
Secondary outcomes (1)
Physiotherapy
Documentation of the execution of a full or partial physical therapy program
Measured: during hospitalization (1-2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement SurgeryStudies 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
- Parallel groups
- Model description
- The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zoya Haitov Ben Zikri, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382285
- Sponsor's protocol ID
- 0206-22-ASF
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Prolonged Peripheral Nerve Block (Utilazing Continuous Adductor Canal Block on the Level of Pain After a Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT06382285
- Acronym / sponsor ID
- 0206-22-ASF
- Conditions
- Knee Replacement Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 24 Apr 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 aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery
Detailed description
Knee replacement surgery is one of the common orthopedic surgeries for the treatment of chronic knee pain. The period after knee replacement surgery is accompanied by moderate to severe pain that affects the patient's ability to quickly return to function. Peripheral nerve blockers and analgesia of different types, administered as part of the anesthesia process, are optimal in controlling pain after surgery. After the surgery, the patients are admitted in the orthopedic inpatient department for 2-3 days on average after surgery for follow-up and early physical therapy necessary to achieve good results and return the patient to full function as soon as possible. The level of pain greatly affects the success rate of the patient's rehabilitation. Thus, since the duration of peripheral nerve block activity does not exceed 8-16 hours on average, it is suggested to treat the patients with a prolonged peripheral nerve block (utilizing continuous adductor canal block) for 24 hours after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Continues peripheral blockropivacaine (Naropin) 0.2% according to a protocol 8-10 cc per hour up to 24 hours after the surgery |
| Control group | Placebo comparator | Drug: Continues peripheral blockSaline according to a protocol 8-10 cc per hour up to 24 hours after the surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female and male patients between the ages of 18 and 80 who have signed an informed consent form.
- ASA is less than 3
- Spinal anesthesia
Key exclusion criteria (1 listed)
- Patients with sensitivity to the anesthetic.
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 |
|---|---|---|
| Continues peripheral blockAlso: Treatment groupropivacaine (Naropin) 0.2% according to a protocol 8-10 cc per hour up to 24 hours after surgery | Drug | Control group, Treatment group |
Primary outcome
Pain level
Time frame: during hospitalization (1-2 days)
Documentation of pain level during the hospitalization days every 12 hours (on a scale of 1-10)
Analgesic use
Time frame: during hospitalization (1-2 days)
Documentation of pain level during the hospitalization days every 12 hours (on a scale of 1-10). Documentation of analgesic administration in hospitalization.
1 secondary outcome
Physiotherapy
Time frame: during hospitalization (1-2 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Continues peripheral block in people with Knee Replacement Surgery, run by Assaf-Harofeh Medical Center.
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 1 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Sara Bar Yehuda, PhD (972528981004, sarabar1@shamir.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: during hospitalization (1-2 days)). The study lists 2 primary outcomes in all. 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 24 Apr 2024.