Intrathecal DexmedetomidineNCT06837844
Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia After Total Knee Arthroplasty
A study testing Intrathecal Dexmedetomidine, Adductor Canal Block and Intrathecal Dexmedetomidine + Adductor Canal Block in people with Intrathecal Dexmedetomidine and Adductor Canal Block, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this work is to evaluate the effect of combined intrathecal dexmedetomidine and adductor canal block for analgesia after total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrathecal Dexmedetomidine, Adductor Canal Block, Analgesia
- What is being tested?
- Intrathecal Dexmedetomidine, Adductor Canal Block and Intrathecal Dexmedetomidine + Adductor Canal Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for total knee arthroplasty under spinal anesthesia.
Who cannot join
- Patients with neurological or intellectual disability.
- History of allergy to local anesthetics or dexmedetomidine .
- Infection at the injection site.
- Prolonged use of analgesic or sedative medications.
- Coagulation abnormalities.
- Pregnancy.
- Obesity [body mass index (BMI) > 30 kg/m2].
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Sherif K Arafa, MD, 00201005714014, Sherifhafez1980@gmail.com
About this study
Official title: Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia After Total Knee Arthroplasty: A Randomized Controlled Trial
The aim of this work is to evaluate the effect of combined intrathecal dexmedetomidine and adductor canal block for analgesia after total knee arthroplasty (TKA).
Read the detailed description
Effective postoperative pain management is essential for improving patient outcomes following knee surgery, facilitating early mobilization, and reducing the risk of complications.
The adductor canal block (ACB) is a nerve block of Hunters canal, which includes the saphenous and vastus medialis nerves. Additionally, other sensory nerves, such as the femoral nerve, medial cutaneous nerve, and both the anterior branch and terminal end of the posterior branch of the obturator nerve to some extent as it enters the distal part of the canal are blocked by the ACB.
Dexmedetomidine (DXM) a highly selective α2 adrenergic agonist with sedative, anxiolytic, analgesic, sympatholytic and antihypertensive effects.
- Being tested
- Intrathecal Dexmedetomidine, Adductor Canal Block, Intrathecal Dexmedetomidine + Adductor Canal Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal DexmedetomidineDrug
Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml saline 0.9% at the end of surgery
Adductor Canal BlockDrug
Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 0.5ml saline 0.9% + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery.
Intrathecal Dexmedetomidine + Adductor Canal BlockDrug
Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group ITD | Experimental | Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml saline 0.9% at the end of surgery Receives: Drug: Intrathecal Dexmedetomidine |
| Group ACB | Active comparator | Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 0.5ml saline 0.9% + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery. Receives: Drug: Adductor Canal Block |
| Group ITD+ACB | Experimental | Patients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery. Receives: Drug: Intrathecal Dexmedetomidine + Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
The patient will receive a 3mg bolus of morphine as a rescue analgesic if the visual analog scale (VAS) was greater than 3, and if the pain persisted for more than 30 mins, the injection was repeated until the VAS became below 4
Measured: 48 hours postoperatively
Secondary outcomes (6)
Time to the 1st rescue analgesia
Time to the 1st rescue analgesia will be recorded from the end of surgery till the first dose of morphine administered.
Measured: 48 hours postoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively
Measured: 48 hours postoperatively
Heart rate
Heart rate will be recorded every 5 minutes till the end of surgery and in post-anesthesia care unit (PACU).
Measured: In post-anesthesia care unit (PACU) (Up to 1 hour)
Mean arterial pressure
Mean arterial pressure will be recorded every 5 minutes till the end of surgery and in post-anesthesia care unit (PACU).
Measured: In post-anesthesia care unit (PACU) (Up to 1 hour)
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 48 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 Feb 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Kamal Arafa, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837844
- Sponsor's protocol ID
- MKSU 50-1-7
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Intrathecal Dexmedetomidine and Adductor Canal Block for Analgesia After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06837844
- Acronym / sponsor ID
- MKSU 50-1-7
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 20 Feb 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 aim of this work is to evaluate the effect of combined intrathecal dexmedetomidine and adductor canal block for analgesia after total knee arthroplasty (TKA).
Detailed description
Effective postoperative pain management is essential for improving patient outcomes following knee surgery, facilitating early mobilization, and reducing the risk of complications.
The adductor canal block (ACB) is a nerve block of Hunters canal, which includes the saphenous and vastus medialis nerves. Additionally, other sensory nerves, such as the femoral nerve, medial cutaneous nerve, and both the anterior branch and terminal end of the posterior branch of the obturator nerve to some extent as it enters the distal part of the canal are blocked by the ACB.
Dexmedetomidine (DXM) a highly selective α2 adrenergic agonist with sedative, anxiolytic, analgesic, sympatholytic and antihypertensive effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group ITD | Experimental | Drug: Intrathecal DexmedetomidinePatients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml saline 0.9% at the end of surgery |
| Group ACB | Active comparator | Drug: Adductor Canal BlockPatients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 0.5ml saline 0.9% + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery. |
| Group ITD+ACB | Experimental | Drug: Intrathecal Dexmedetomidine + Adductor Canal BlockPatients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 75 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for total knee arthroplasty under spinal anesthesia.
Key exclusion criteria (7 listed)
- Patients with neurological or intellectual disability.
- History of allergy to local anesthetics or dexmedetomidine .
- Infection at the injection site.
- Prolonged use of analgesic or sedative medications.
- Coagulation abnormalities.
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 |
|---|---|---|
| Intrathecal DexmedetomidinePatients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml saline 0.9% at the end of surgery | Drug | Group ITD |
| Adductor Canal BlockPatients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 0.5ml saline 0.9% + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery. | Drug | Group ACB |
| Intrathecal Dexmedetomidine + Adductor Canal BlockPatients will receive 15mg in 3ml hyperbaric bupivacaine intrathecally with 5 μg in 0.5ml dexmedetomidine + adductor canal block using 20 ml bupivacaine 0.25% at the end of surgery. | Drug | Group ITD+ACB |
Primary outcome
Total morphine consumption
Time frame: 48 hours postoperatively
The patient will receive a 3mg bolus of morphine as a rescue analgesic if the visual analog scale (VAS) was greater than 3, and if the pain persisted for more than 30 mins, the injection was repeated until the VAS became below 4
6 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 48 hours postoperatively
Degree of pain
Time frame: 48 hours postoperatively
Heart rate
Time frame: In post-anesthesia care unit (PACU) (Up to 1 hour)
Mean arterial pressure
Time frame: In post-anesthesia care unit (PACU) (Up to 1 hour)
Degree of patient satisfaction
Time frame: 48 hours postoperatively
Incidence of adverse events
Time frame: 48 hours postoperatively
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 21 Feb 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Intrathecal Dexmedetomidine
Active, not recruitingEarly Phase 1
Comparison of Analgesic Efficacy of Intrathecal Bupivacaine Versus Bupivacaine Plus Dexmedetomidine in Patients Undergoing Orthopedic Surgeries.
Postoperative Pain, Pain
Not yet recruitingPhase 4
Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG
Total Hip Arthroplasty (THA), Intrathecal Anesthesia
Not yet recruitingPhase 2/3
Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery
Postoperative Delirium, Hip Fractures
Enrolling by invitationPhase 1/2
This Study Aims to Determine Whether Lower Doses (4 µg) of Intrathecal Dexmedetomidine Can Provide Comparable Analgesic Benefits While Minimizing Adverse Hemodynamic Effects in Patients Encountered in Our Setup( Shifa International Hospital Islamabad).
Intrathecal Dexmedetomidine
Not yet recruitingPhase 4
Ultrasound-Guided Posterior Quadratus Lumborum Block With Bupivacaine and Dexmedetomidine Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Postoperative Analgesia After Cesarean Delivery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Dexmedetomidine, Adductor Canal Block and Intrathecal Dexmedetomidine + Adductor Canal Block in people with Intrathecal Dexmedetomidine and Adductor Canal Block, run by Kafrelsheikh 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Feb 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?
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?
Contact Sherif K Arafa, MD (00201005714014, Sherifhafez1980@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 48 hours postoperatively). 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 21 Feb 2025.