Postoperative PainNCT06527976
Dexamethasone Versus Demedetomidine Addition for Adductor Canal Block
A study testing Dexmedetomidine and Dexamethasone in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 1 Jan 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- elective operation
- ASA STATUS I and II
Who cannot join
- patient refusal
- ASA status III and IV
- contraindications to local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomedine Versus Dexamethasone in Ultrasound Guided Adductor Canal Block for Patients Undergoing Knee Arthroscope
Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics.
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine, Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomedine added to bupivacaine for adductor canal block
DexamethasoneDrug
dexamethasone added to bupivacaine for adductor canal block
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale score
scale of 11 points. zero=no pain, 10 = worest pain ever
Measured: 24 hours postoperative
Secondary outcomes (2)
analgesia duration
pain free duration after block
Measured: 24 hours postoperative
opioid consumption
amount of opioid consumed postoperative
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start15 Feb 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527976
- Sponsor's protocol ID
- 12222
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomedine Versus Dexamethasone in Ultrasound Guided Adductor Canal Block for Patients Undergoing Knee Arthroscope
- ClinicalTrials.gov ID
- NCT06527976
- Acronym / sponsor ID
- 12222
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 30 Jul 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.
Single-injection peripheral nerve block (PNB) is commonly used for perioperative analgesia and anesthesia. Three approaches for extending the duration of PNB include continuous PNB with catheter-based techniques, novel local anesthetics delivery systems and addition of novel adjuvants to local anesthetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| dexamethasone | Active comparator | Drug: Dexamethasone |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- elective operation
- ASA STATUS I and II
Key exclusion criteria (3 listed)
- patient refusal
- ASA status III and IV
- contraindications to local anesthesia
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 |
|---|---|---|
| Dexmedetomidinedexmedetomedine added to bupivacaine for adductor canal block | Drug | dexmedetomidine |
| Dexamethasonedexamethasone added to bupivacaine for adductor canal block | Drug | dexamethasone |
Primary outcome
visual analogue scale score
Time frame: 24 hours postoperative
scale of 11 points. zero=no pain, 10 = worest pain ever
2 secondary outcomes
analgesia duration
Time frame: 24 hours postoperative
opioid consumption
Time frame: 24 hours postoperative
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 30 Jul 2024.
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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.
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 Dexmedetomidine and Dexamethasone in people with Postoperative Pain, run by Assiut 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 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: finished, as of the sponsor's last update on 30 Jul 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?
visual analogue scale score (time frame: 24 hours postoperative). 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 30 Jul 2024.