Postoperative PainNCT02581566
Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
A study testing Intrathecal Dexmedetomidine, Intraarticular Dexmedetomidine and Bupivacaine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intrathecal Dexmedetomidine, Intraarticular Dexmedetomidine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2015to Apr 2016
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia.
Who cannot join
- Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy.
- Conditions
- Postoperative Pain
- Being tested
- Intrathecal Dexmedetomidine, Intraarticular Dexmedetomidine, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal DexmedetomidineDrug
Addition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine
Intraarticular DexmedetomidineDrug
Addition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine
BupivacaineDrug
Intrathecal Bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Dexmedetomidine Group | Active comparator | 30 patients will be given Intrathecal Dexmedetomidine plus Intrathecal Bupivacaine Receives: Drug: Intrathecal Dexmedetomidine |
| Intraarticular Dexmedetomidine Group | Active comparator | 30 patients will be given Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine Receives: Drug: Intraarticular Dexmedetomidine |
| control Group | Other | 30 patients will be given Intrathecal Bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Assesment is done by Visual Analog Scale
Measured: 24 hours
Secondary outcomes (1)
c-reactive protein
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionApr 2016
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman A. Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581566
- Sponsor's protocol ID
- 01003060215
- Status last verified
- Mar 2019
- First submitted
- 18 Oct 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy
- ClinicalTrials.gov ID
- NCT02581566
- Acronym / sponsor ID
- 01003060215
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
Comparison between intrathecal Dexmedetomidine versus Intraarticular Dexmedetomidine on postoperative pain after knee arthroscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Dexmedetomidine Group | Active comparator | Drug: Intrathecal Dexmedetomidine30 patients will be given Intrathecal Dexmedetomidine plus Intrathecal Bupivacaine |
| Intraarticular Dexmedetomidine Group | Active comparator | Drug: Intraarticular Dexmedetomidine30 patients will be given Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine |
| control Group | Other | Drug: Bupivacaine30 patients will be given Intrathecal Bupivacaine |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult patients, ASA I-II, undergoing knee arthroscopy under spinal anesthesia.
Key exclusion criteria (1 listed)
- Absolute or relative contraindications to spinal anesthesia, allergy to dexmedetomidine or chronic pain treatment.
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 DexmedetomidineAddition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine | Drug | Intrathecal Dexmedetomidine Group |
| Intraarticular DexmedetomidineAddition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine | Drug | Intraarticular Dexmedetomidine Group |
| BupivacaineIntrathecal Bupivacaine | Drug | control Group |
Primary outcome
postoperative pain
Time frame: 24 hours
Assesment is done by Visual Analog Scale
1 secondary outcome
c-reactive protein
Time frame: 24 hours
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 13 Mar 2019.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 Intrathecal Dexmedetomidine, Intraarticular Dexmedetomidine and Bupivacaine 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 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: finished, as of the sponsor's last update on 13 Mar 2019. 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?
postoperative pain (time frame: 24 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 13 Mar 2019.