Post Operative AnalgesiaPhase 3DEXMEDNCT06665438
Dexmedetomidine and Bupivacaine Intra-articular for Postoperative Analgesia After Knee Arthroscopic Surgery
A Phase 3 study testing Bupivacaine 0.25% and Dexmedetomidine in people with Post Operative Analgesia, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
The aim of this study to compare the analgesic effects of intraarticular dexmedetomidine added to bupivacaine with those of bupivacaine alone after knee arthroscopy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- Bupivacaine 0.25% and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2024to Apr 2025
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients
- Either sex
- Aged 18-65 years
- Candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy
Who cannot join
- the patients with kidney failure, liver failure, valvular and ischemic heart disease , high blood pressure, diabetes, history of infection and malignancy.
- history of coagulation diseases, and history of drug allergies to used drugs.
- those who consumed NSAIDs and analgesics 24 h before surgery were excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Al-Azhar University
Asyut, 71523
Mohamed A. Mahmoud, M.D, 01002538320 ext. 002, mohamedali.226@azhar.edu.eg
Mohamed A Mahmoud, M.D, 01002538320 ext. 002, mohamedali.226@azhar.edu.eg
- Not yet recruiting
Al-Azhar University
Asyut
Mohamed A. Mahmoud, 01002538320 ext. 002, mohamedali.226@azhar.edu.eg
Mohamed A Mahmoud, 01002538320 ext. 002, mohamedali.226@azhar.edu.eg
About this study
Official title: Impact of Dexmedetomidine Add to Intra-articular Bupivacaine for Post Operative Analgesia After Knee Arthroscopic Surgery
The aim of this study to compare the analgesic effects of intraarticular dexmedetomidine added to bupivacaine with those of bupivacaine alone after knee arthroscopy
Read the detailed description
prospective double-blind study perform on 75 patients candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy refer to the clinic of Al Azhar University Hospital, Assiut, Egypt, to evaluate the effect of adding dexmedetomidine to intra articular bupivacaine injection on postoperative pain after knee arthroscopy.
- Conditions
- Post Operative Analgesia
- Being tested
- Normal Saline (Placebo), Bupivacaine 0.25%, Dexmedetomidine
- Keywords
- Knee arthroscopy, Bupivacaine, Dexmedetomidine, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline (Placebo)Drug
the 18 ml of normal saline will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
Bupivacaine 0.25%Drug
the 18ml 0.25% bupivacaine. will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
DexmedetomidineDrug
Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.
| Study group | Role | What they receive |
|---|---|---|
| group of control (C) | Experimental | receive 18 ml of normal saline only and serve as the control group.the normal saline will injected in the knee joint by the surgeon through the arthroscope after completing the procedure Receives: Drug: Normal Saline (Placebo) |
| groups of Bupivacaine (B) | Experimental | The 18ml 0.25% bupivacaine will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure Receives: Drug: Bupivacaine 0.25%; Drug: Dexmedetomidine |
| groups of dexmedetomidine (D) | Experimental | Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain )to assessment the duration of analgesia following the surgery
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain) to assessment the duration of analgesia following intra articular injection of Bupivacaine and Dexmedetomidine after knee arthroscopy
Measured: post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour .
Secondary outcomes (1)
Total meperidine consumption . Meperidine will be used intravenously if the visual analog scale ( VAS) score was >50 to control postoperative pain.
the secondary outcome variables will be the total dose of meperidine given between the study groups.Meperidine will be used intravenously if the visual analog scale ( VAS) score was >50 to control postoperative pain.
Measured: The total dose of meperidine given between the study groups during the first 24 hour( post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour),will be recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Dec 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients randomly allocate to one of three groups (n =25) for intra articular injection using Sealed envelope method as follows: Group (C), receive 18 ml saline only and serve as the control group(C). Group (B) receive 18ml 0.25% bupivacaine. Group(D)received 18 ml 0.25% bupivacaine and dexmedetomidine 1 μg/kg, the study drugs will injected in the knee joint by the surgeon through the arthroscope after completing the procedure (without knowing the drugs used)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Mahmoud, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665438
- Sponsor's protocol ID
- AZAST/Research/88/14-MAY-2024.
- Acronym
- DEXMED
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 22 Apr 2025
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dexmedetomidine Add to Intra-articular Bupivacaine for Post Operative Analgesia After Knee Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT06665438
- Acronym / sponsor ID
- DEXMED / AZAST/Research/88/14-MAY-2024.
- Conditions
- Post Operative Analgesia
- Keywords
- Knee arthroscopy, Bupivacaine, Dexmedetomidine, Postoperative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 30 Oct 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 to compare the analgesic effects of intraarticular dexmedetomidine added to bupivacaine with those of bupivacaine alone after knee arthroscopy
Detailed description
prospective double-blind study perform on 75 patients candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy refer to the clinic of Al Azhar University Hospital, Assiut, Egypt, to evaluate the effect of adding dexmedetomidine to intra articular bupivacaine injection on postoperative pain after knee arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- patients randomly allocate to one of three groups (n =25) for intra articular injection using Sealed envelope method as follows: Group (C), receive 18 ml saline only and serve as the control group(C). Group (B) receive 18ml 0.25% bupivacaine. Group(D)received 18 ml 0.25% bupivacaine and dexmedetomidine 1 μg/kg, the study drugs will injected in the knee joint by the surgeon through the arthroscope after completing the procedure (without knowing the drugs used)
| Arm | Type | Receives |
|---|---|---|
| group of control (C) | Experimental | Drug: Normal Saline (Placebo)receive 18 ml of normal saline only and serve as the control group.the normal saline will injected in the knee joint by the surgeon through the arthroscope after completing the procedure |
| groups of Bupivacaine (B) | Experimental | Drug: Bupivacaine 0.25%, Drug: DexmedetomidineThe 18ml 0.25% bupivacaine will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure |
| groups of dexmedetomidine (D) | Experimental | Drug: DexmedetomidineDexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-II patients
- Either sex
- Aged 18-65 years
- Candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy
Key exclusion criteria (3 listed)
- the patients with kidney failure, liver failure, valvular and ischemic heart disease , high blood pressure, diabetes, history of infection and malignancy.
- history of coagulation diseases, and history of drug allergies to used drugs.
- those who consumed NSAIDs and analgesics 24 h before surgery were excluded from the study.
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 |
|---|---|---|
| Normal Saline (Placebo)the 18 ml of normal saline will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure | Drug | group of control (C) |
| Bupivacaine 0.25%the 18ml 0.25% bupivacaine. will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure | Drug | groups of Bupivacaine (B) |
| DexmedetomidineDexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure. | Drug | groups of Bupivacaine (B), groups of dexmedetomidine (D) |
Primary outcome
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain )to assessment the duration of analgesia following the surgery
Time frame: post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour .
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain) to assessment the duration of analgesia following intra articular injection of Bupivacaine and Dexmedetomidine after knee arthroscopy
1 secondary outcome
Total meperidine consumption . Meperidine will be used intravenously if the visual analog scale ( VAS) score was >50 to control postoperative pain.
Time frame: The total dose of meperidine given between the study groups during the first 24 hour( post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour),will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Post Operative Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine 0.25% and Dexmedetomidine in people with Post Operative Analgesia, run by Al-Azhar University at 2 sites 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 4 inclusion and 3 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 22 Apr 2025. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohamed A. Mahmoud, MD (01002538320 ext. 002, mohamedali.226@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain )to assessment the duration of analgesia following the surgery (time frame: post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour .). 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 22 Apr 2025.