Efficacy of Drugs in Pain ManagementPhase 1/2NCT07024043
Dexamethasone Versus Dexmedetomidine in IPACK Block to Reduce Pain Post Arthroscopic Knee Surgeries
A Phase 1/2 study testing Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries and IPACK and multi-modal analgesic regimen in people with Efficacy of Drugs in Pain Management, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators will test the effects of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in IPACK Block and it's direct effect in decreasing pain post operative following Arthroscopic knee surgeries Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficacy of Drugs in Pain Management
- What is being tested?
- Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries and IPACK and multi-modal analgesic regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2025to 3 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physical status: ASA I,II. Both sexes. BMI<35
Who cannot join
- Refusal of the procedure or participation in the study by the patient. Physical status: ASA III or Above. History of allergy to the study drug. Evidence of local infection at site of injection. Major hepatic, renal, or cardiovascular dysfunction. BMI>35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia Following Arthroscopic Knee Surgeries
The investigators will test the effects of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in IPACK Block and it's direct effect in decreasing pain post operative following Arthroscopic knee surgeries
Read the detailed description
A.Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. B.Intraoperative and postoperative settings: On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\kg. For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .
- Conditions
- Efficacy of Drugs in Pain Management
- Being tested
- Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries, IPACK and multi-modal analgesic regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeriesDrug
Blocks will be carried out with the patient supine with the operative leg externally rotated and slightly flexed at the knee or in prone position.with Ultrasound device with a high-frequency (6-13 MHz) linear probe using in plane lateral to medial approach and this will be done by a senior staff anaesthesia physician skilled in ultrasound guided regional anaesthesia.
IPACK and multi-modal analgesic regimenProcedure or surgery
patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .
| Study group | Role | What they receive |
|---|---|---|
| (Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivac | Experimental | For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine . Receives: Drug: Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries; Procedure: IPACK and multi-modal analgesic regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries
postoperative analgesic effect will be assessed by the time till first analgesic requirement which is defined as the time (in hours) after finishing of ultrasound guided iPACK block till the patient's requirement for first analgesia postoperative in ward.
Postoperative pain will be assessed by visual analog scale (VAS) up to 24 h after surgery. Whenever VAS score reached ≥ 4, rescue analgesia will be given in the form of iv injection diclofenac sodium 75 mg. Time to the first dose of diclofenac sodium postoperatively will be recorded
Measured: 45 minutes after spinal anaesthesia
Secondary outcomes (1)
Effect Of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia following Arthroscopic Knee Surgeries
Total analgesics consumption (in mg.) over 24-hour period post-operative.
Incidence of adverse effects such as:
Hematoma, hypotension (considered as significant hypotension when blood pressure decrease by 20% relative to baseline), bradycardia (considered as significant bradycardia when heart rate decrease by 20% relative to baseline), nausea and/or vomiting, local anesthetic toxicity, post operative paresthesia, sedation (assessed by Ramsay sedation score) and hypoxemia (Spao2<90%) will be recorded in both groups and will be properly managed by fluid reuscitation, oxygen support, vasopressor and proton pump inhibitors.
Post-operative ambulation enhancement in the form of: time of start of ambulation (in hours) starting from end of surgery- walking- climbing stairs (according to the New Knee Society Knee Scoring System)
Measured: 45 minutes after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start3 Mar 2025
- Primary completion3 Sep 2025 (estimated)
- Study completion3 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Drugs in Pain ManagementStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maisa Essam Abdelhaleem, MBBCH, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024043
- Sponsor's protocol ID
- FMASU MS 173/2025
- Status last verified
- Mar 2025
- First submitted
- 6 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia Following Arthroscopic Knee Surgeries
- ClinicalTrials.gov ID
- NCT07024043
- Acronym / sponsor ID
- FMASU MS 173/2025
- Conditions
- Efficacy of Drugs in Pain Management
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 3 Sep 2025 (estimated)
- First posted
- 17 Jun 2025 (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 investigators will test the effects of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in IPACK Block and it's direct effect in decreasing pain post operative following Arthroscopic knee surgeries
Detailed description
A.Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. B.Intraoperative and postoperative settings: On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\kg. For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivac | Experimental | Drug: Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries, Procedure: IPACK and multi-modal analgesic regimenFor each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physical status: ASA I,II. Both sexes. BMI<35
Key exclusion criteria (1 listed)
- Refusal of the procedure or participation in the study by the patient. Physical status: ASA III or Above. History of allergy to the study drug. Evidence of local infection at site of injection. Major hepatic, renal, or cardiovascular dysfunction. BMI>35.
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 versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeriesBlocks will be carried out with the patient supine with the operative leg externally rotated and slightly flexed at the knee or in prone position.with Ultrasound device with a high-frequency (6-13 MHz) linear probe using in plane lateral to medial approach and this will be done by a senior staff anaesthesia physician skilled in ultrasound guided regional anaesthesia. | Drug | (Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivac |
| IPACK and multi-modal analgesic regimenpatients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine . | Procedure or surgery | (Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivac |
Primary outcome
Efficacy of Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries
Time frame: 45 minutes after spinal anaesthesia
postoperative analgesic effect will be assessed by the time till first analgesic requirement which is defined as the time (in hours) after finishing of ultrasound guided iPACK block till the patient's requirement for first analgesia postoperative in ward. Postoperative pain will be assessed by visual analog scale (VAS) up to 24 h after surgery. Whenever VAS score reached ≥ 4, rescue analgesia will be given in the form of iv injection diclofenac sodium 75 mg. Time to the first dose of diclofenac sodium postoperatively will be recorded
1 secondary outcome
Effect Of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia following Arthroscopic Knee Surgeries
Time frame: 45 minutes after spinal anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
Related trials for Efficacy of Drugs in Pain Management
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
RecruitingPhase 3
Morphine or Ketamine for Analgesia
Abdominal Pain, Isolated Extremity Fracture
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.
Maisa Essam Abdelhaleem, MBBCH principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries and IPACK and multi-modal analgesic regimen in people with Efficacy of Drugs in Pain Management, run by Ain Shams 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 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Efficacy of Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries (time frame: 45 minutes after spinal anaesthesia). 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 17 Jun 2025.