Genicular Nerve Block for Pain in ACL ArthroscopyNCT05813834
Ultrasound-guided Genicular Nerves Block
A study testing Genicular Nerves Block in people with Genicular Nerve Block for Pain in ACL Arthroscopy, run by Cairo University at 1 site in Egypt.
Trial summary
Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Genicular Nerve Block for Pain in ACL Arthroscopy
- What is being tested?
- Genicular Nerves Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 30 Mar 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- both genders
- age 18 - 65
- ASA i, ii, iii
Who cannot join
- ROM less than 90
- advanced renal or liver diseases
- patient refusal
- substance abuse
- site infection
- known sensitivity to any of study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: US-guided Genicular Nerves Block for Pain Control After Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Double Blinded, Randomized Controlled Study
Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay.
in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.
Read the detailed description
In this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.
- Being tested
- Genicular Nerves Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular Nerves BlockProcedure or surgery
US guided genicular nerves block
| Study group | Role | What they receive |
|---|---|---|
| genicular nerve block group | Active comparator | patients will receive genicular nerves block Receives: Procedure: Genicular Nerves Block |
| control group | No intervention | patients will not receive genicular nerves block |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative VAS
vas score
Measured: 24 hours
Secondary outcomes (4)
total morphine consumption
morphine onsumpton
Measured: 24 hours
time to first morphine analgesia
rescue analgesia
Measured: 24 hours
range of motion
rom
Measured: 24 hours
post operative MAP
map
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 posted14 Apr 2023
- Study start1 Jun 2023
- Primary completion15 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genicular Nerve Block for Pain in ACL ArthroscopyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Genicular Nerves Block
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ismail, Cairo University
- Investigators
- Dalia K Ismail, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813834
- Sponsor's protocol ID
- MS-502-2022
- Status last verified
- Nov 2024
- First submitted
- 3 Apr 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US-guided Genicular Nerves Block for Pain Control After Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Double Blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05813834
- Acronym / sponsor ID
- MS-502-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 14 Apr 2023 (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.
Most of arthroscopic ACL repairs are day case surgeries associated with moderate postoperative pain and discomfort. So , finding an effective and safe, analgesic technique with minimal complications is our goal for fast recovery and short hospital stay.
in this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.
Detailed description
In this study, we aim to compare the efficacy of genicular nerve block against controls on postoperative pain scores, the need for rescue analgesics, patient's satisfaction and range of motion (ROM) after arthroscopic ACL cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Genicular Nerves Block
| Arm | Type | Receives |
|---|---|---|
| genicular nerve block group | Active comparator | Procedure: Genicular Nerves Blockpatients will receive genicular nerves block |
| control group | No intervention | –patients will not receive genicular nerves block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- both genders
- age 18 - 65
- ASA i, ii, iii
Key exclusion criteria (6 listed)
- ROM less than 90
- advanced renal or liver diseases
- patient refusal
- substance abuse
- site infection
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 |
|---|---|---|
| Genicular Nerves BlockUS guided genicular nerves block | Procedure or surgery | genicular nerve block group |
Primary outcome
post operative VAS
Time frame: 24 hours
vas score
4 secondary outcomes
total morphine consumption
Time frame: 24 hours
time to first morphine analgesia
Time frame: 24 hours
range of motion
Time frame: 24 hours
post operative MAP
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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.
Dalia K Ismail principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genicular Nerves Block in people with Genicular Nerve Block for Pain in ACL Arthroscopy, run by Cairo University at 1 site in Egypt.
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 6 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: finished, as of the sponsor's last update on 14 Nov 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative VAS (time frame: 24 hours). 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 14 Nov 2024.