Knee SurgeriesNCT07058493
Dexmedetomidine as an Additive for (Ipack)Block in Knee Surgery
A study testing Dexmedetomidine and Bupivacaine in people with Knee Surgeries, run by Cairo University at 1 site in Egypt.
Trial summary
Dexmedetomidine used as an Additive for Ipack Block in Knee Surgery Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Surgeries
- What is being tested?
- Dexmedetomidine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2024to 30 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years
- ASA I, II .patients undergoing knee surgeries.
Who cannot join
- patient Refusal
- bleeding disorders
- skin lesion
- infection
- known allergy
- contradictions of spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Using Dexmedetomidine as an Additive for (Ipack)Block in Knee Surgeries in Adult Patient; A Randomized Controlled Trial
Dexmedetomidine used as an Additive for Ipack Block in Knee Surgery
Read the detailed description
Many types of analgesia used but multimodal analgesia showed best results The interspace between the popliteal artery and capsule of the posterior knee (IPACK) block aims to blockade of sciatic nerve terminal branches for analgesia without motor affection
. (IPACK) block is a motor power sparing procedure that involves injecting local anesthetic into the space between the popliteal artery and the posterior capsule of the knee in order to treat posterior knee pain
- Conditions
- Knee Surgeries
- Being tested
- Dexmedetomidine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomidine 100 μg as adjuvant to IPACK block with 20 ml of bupivacaine 0.25%.
BupivacaineDrug
20 ml of bupivacaine 0.25%.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Experimental | IPACK block with 20ml bupivacaine 0.25% alone.
. Receives: Drug: Bupivacaine |
| Dexmedetomidine | Experimental | IPACK block with 20 ml of bupivacaine 0.25% with dexmedetomidine 100 μg as adjuvant. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale at rest score during first postoperative 48 hours
Visual Analog Scale at rest during first postoperative 48 hours a line 10centimeters long from zero to10 where 10 is the worst pain ever
Measured: 48 postoperative hours
Secondary outcomes (6)
Visual Analog Scale at rest and during movement at 30 minuts, 2, 8, 16, 24, 36, and 48 hours
Visual Analog Scale at rest during 48 postoperative hour a line 10centimeters long from zero to10 where 10 is the worst pain ever
Measured: 48 postoperative hours
Duration of the block
Duration of the block
Measured: 48 hours
Heart Rate
Heart Rate
Measured: 48 hours
Mean Arterial Pressure
Mean Arterial Pressure
Measured: 48 hours
Block performance time in minutes
Block performance time in minutes
Measured: preoperative
Incidence of adverse effects
Incidence of adverse effects
Measured: 2 hours inPACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start2 Jan 2024
- Primary completion10 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee SurgeriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT07058493
- Sponsor's protocol ID
- MS-491-2023
- Status last verified
- Jun 2025
- First submitted
- 5 May 2024
- Last updated
- 10 Jul 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Using Dexmedetomidine as an Additive for (Ipack)Block in Knee Surgeries in Adult Patient; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07058493
- Acronym / sponsor ID
- MS-491-2023
- Conditions
- Knee Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 10 Jul 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.
Dexmedetomidine used as an Additive for Ipack Block in Knee Surgery
Detailed description
Many types of analgesia used but multimodal analgesia showed best results The interspace between the popliteal artery and capsule of the posterior knee (IPACK) block aims to blockade of sciatic nerve terminal branches for analgesia without motor affection
. (IPACK) block is a motor power sparing procedure that involves injecting local anesthetic into the space between the popliteal artery and the posterior capsule of the knee in order to treat posterior knee pain
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Experimental | Drug: BupivacaineIPACK block with 20ml bupivacaine 0.25% alone. . |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineIPACK block with 20 ml of bupivacaine 0.25% with dexmedetomidine 100 μg as adjuvant. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-60 years
- ASA I, II .patients undergoing knee surgeries.
Key exclusion criteria (6 listed)
- patient Refusal
- bleeding disorders
- skin lesion
- infection
- known allergy
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 |
|---|---|---|
| Dexmedetomidinedexmedetomidine 100 μg as adjuvant to IPACK block with 20 ml of bupivacaine 0.25%. | Drug | Dexmedetomidine |
| Bupivacaine20 ml of bupivacaine 0.25%. | Drug | Bupivacaine |
Primary outcome
Visual Analog Scale at rest score during first postoperative 48 hours
Time frame: 48 postoperative hours
Visual Analog Scale at rest during first postoperative 48 hours a line 10centimeters long from zero to10 where 10 is the worst pain ever
6 secondary outcomes
Visual Analog Scale at rest and during movement at 30 minuts, 2, 8, 16, 24, 36, and 48 hours
Time frame: 48 postoperative hours
Duration of the block
Time frame: 48 hours
Heart Rate
Time frame: 48 hours
Mean Arterial Pressure
Time frame: 48 hours
Block performance time in minutes
Time frame: preoperative
Incidence of adverse effects
Time frame: 2 hours inPACU
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 10 Jul 2025.
- 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.
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 Dexmedetomidine and Bupivacaine in people with Knee Surgeries, 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 2 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 10 Jul 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.
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?
Visual Analog Scale at rest score during first postoperative 48 hours (time frame: 48 postoperative 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 10 Jul 2025.