ACL InjuryNCT06537518
The Difference Between Using Local and General Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair
A study testing Dexamethasone injection, Bupivacaine 0.375% Injectable Solution and Bupivacaine 0.5% Injectable Solution in people with ACL Injury, run by Benha University at 1 site in Egypt.
Trial summary
Arthroscopic knee injuries, such as the anterior cruciate ligament (ACL) injury, are common and often result in postoperative pain. Regional anesthetic techniques, such as femoral nerve block (FNB) and adductor canal block (ACB), can help alleviate pain and reduce opioid consumption. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Dexamethasone injection, Bupivacaine 0.375% Injectable Solution and Bupivacaine 0.5% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 25 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with ACL injury;
- Patients in class I, II according to American Society of Anesthesiologists (ASA) classification.
Who cannot join
- Patients free of all Inclusion Criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adductor Canal Block With Dexamethasone Versus Adductor Canal Block With Systemic Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair
Arthroscopic knee injuries, such as the anterior cruciate ligament (ACL) injury, are common and often result in postoperative pain. Regional anesthetic techniques, such as femoral nerve block (FNB) and adductor canal block (ACB), can help alleviate pain and reduce opioid consumption. ACB, which blocks the saphenous nerve and obturator nerve branches, is preferred over FNB due to its potential to decrease mobility and increase falls risk. Dexamethasone, a potent glucocorticoid, is used as an adjuvant for ACB, but its perineural administration may carry neurotoxicity risks. Some pain physicians prefer intravenous administration to prolong the action of local anesthetics used in peripheral nerve blocks.
- Conditions
- ACL Injury
- Being tested
- Dexamethasone injection, Bupivacaine 0.375% Injectable Solution, Bupivacaine 0.5% Injectable Solution
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone injectionDrug
Dexamethasone, a potent glucocorticoid, decreases the inflammatory response, tissue damage, and pain after surgical procedures; which can be injected locally or Intravenously.
Bupivacaine 0.375% Injectable SolutionDrug
Isobaric bupivacaine (0.375%) is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space.
Bupivacaine 0.5% Injectable SolutionDrug
20 ml of Bupivacain 0.5% was mixed with dexamethasone 8 mg is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space.
| Study group | Role | What they receive |
|---|---|---|
| IV anesthetic Group | Active comparator | Not described Receives: Drug: Dexamethasone injection; Drug: Bupivacaine 0.375% Injectable Solution |
| Local anesthetic Group | Active comparator | Not described Receives: Drug: Dexamethasone injection; Drug: Bupivacaine 0.5% Injectable Solution |
| Control Group | Active comparator | Not described Receives: Drug: Bupivacaine 0.375% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-arthroscopic ACL management.
Value of administration of dexamethasone enhancing the analgesic action of bupivacaine used in ACB after arthroscopic management of the ACL.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 May 2022
- Primary completion20 Nov 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Sharara, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537518
- Sponsor's protocol ID
- RC 43-11-2023
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block With Dexamethasone Versus Adductor Canal Block With Systemic Dexamethasone in Arthroscopic Anterior Cruciate Ligament Repair
- ClinicalTrials.gov ID
- NCT06537518
- Acronym / sponsor ID
- RC 43-11-2023
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 5 Aug 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.
Arthroscopic knee injuries, such as the anterior cruciate ligament (ACL) injury, are common and often result in postoperative pain. Regional anesthetic techniques, such as femoral nerve block (FNB) and adductor canal block (ACB), can help alleviate pain and reduce opioid consumption. ACB, which blocks the saphenous nerve and obturator nerve branches, is preferred over FNB due to its potential to decrease mobility and increase falls risk. Dexamethasone, a potent glucocorticoid, is used as an adjuvant for ACB, but its perineural administration may carry neurotoxicity risks. Some pain physicians prefer intravenous administration to prolong the action of local anesthetics used in peripheral nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV anesthetic Group | Active comparator | Drug: Dexamethasone injection, Drug: Bupivacaine 0.375% Injectable Solution |
| Local anesthetic Group | Active comparator | Drug: Dexamethasone injection, Drug: Bupivacaine 0.5% Injectable Solution |
| Control Group | Active comparator | Drug: Bupivacaine 0.375% Injectable Solution |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with ACL injury;
- Patients in class I, II according to American Society of Anesthesiologists (ASA) classification.
Key exclusion criteria (1 listed)
- Patients free of all Inclusion Criteria.
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 |
|---|---|---|
| Dexamethasone injectionDexamethasone, a potent glucocorticoid, decreases the inflammatory response, tissue damage, and pain after surgical procedures; which can be injected locally or Intravenously. | Drug | IV anesthetic Group, Local anesthetic Group |
| Bupivacaine 0.375% Injectable SolutionIsobaric bupivacaine (0.375%) is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space. | Drug | Control Group, IV anesthetic Group |
| Bupivacaine 0.5% Injectable Solution20 ml of Bupivacain 0.5% was mixed with dexamethasone 8 mg is injected into the adductor canal deeply to the sartorius muscle around the saphenous nerve after ensuring negative aspiration space. | Drug | Local anesthetic Group |
Primary outcome
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-arthroscopic ACL management.
Time frame: 6 months
Value of administration of dexamethasone enhancing the analgesic action of bupivacaine used in ACB after arthroscopic management of the ACL.
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 5 Aug 2024.
Related trials for ACL Injury
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone injection, Bupivacaine 0.375% Injectable Solution and Bupivacaine 0.5% Injectable Solution in people with ACL Injury, run by Benha 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 2 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: finished, as of the sponsor's last update on 5 Aug 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?
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-arthroscopic ACL management. (time frame: 6 months). 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 5 Aug 2024.