Postoperative PainPhase 2NCT02818985
Analgesia in Knee Arthroscopic Surgery
A Phase 2 study testing Dexamethasone, Dexmedetomidine and Saline in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function. 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?
- Dexamethasone, Dexmedetomidine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2016to Feb 2017
- Phase
- Phase 2
- 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
- Patients scheduled for knee arthroscopy under spinal anaesthesia
Who cannot join
- Diabetes Mellitus
- Contraindication to spinal anesthesia
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-articular Dexamethasone vs Intra-articular Dexamedetomidine
Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.
Read the detailed description
Intra-articular analgesia is useful in reducing patients' postoperative disability. It anticipates and prevents the onset of pain, and helps avoid the need for additional drugs. Usually it is possible to reach good analgesia in the immediate postoperative period by the administration of analgesic drugs. Recently, intra-articular administration of different anaesthetic substances with a local action (e.g. bupivacaine) has been introduced in clinical practice. The aim of the administration of these substances should not be the reduction of postoperative pain, but its prevention.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Dexmedetomidine, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.
DexmedetomidineDrug
patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.
SalineDrug
patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint. Receives: Drug: Dexamethasone |
| Dexmedetomidine | Active comparator | patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint. Receives: Drug: Dexmedetomidine |
| Control | Placebo comparator | patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain free time
VAS
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, MD, Principal investigator, Assiut Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818985
- Sponsor's protocol ID
- SM2016
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Moeen SM, Ramadan IK, Elkady HA. Dexamethasone and Dexmedetomidine as an Adjuvant to Intraarticular Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery: A Randomized Trial. Pain Physician. 2017 Nov;20(7):671-680.
PubMed 29149146
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Dexamethasone vs Intra-articular Dexamedetomidine
- ClinicalTrials.gov ID
- NCT02818985
- Acronym / sponsor ID
- SM2016
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 30 Jun 2016 (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.
Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.
Detailed description
Intra-articular analgesia is useful in reducing patients' postoperative disability. It anticipates and prevents the onset of pain, and helps avoid the need for additional drugs. Usually it is possible to reach good analgesia in the immediate postoperative period by the administration of analgesic drugs. Recently, intra-articular administration of different anaesthetic substances with a local action (e.g. bupivacaine) has been introduced in clinical practice. The aim of the administration of these substances should not be the reduction of postoperative pain, but its prevention.
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 |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasonepatients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint. |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidinepatients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint. |
| Control | Placebo comparator | Drug: Salinepatients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled for knee arthroscopy under spinal anaesthesia
Key exclusion criteria (3 listed)
- Diabetes Mellitus
- Contraindication to spinal anesthesia
- Patient refusal
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 |
|---|---|---|
| Dexamethasonepatients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint. | Drug | Dexamethasone |
| Dexmedetomidinepatients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint. | Drug | Dexmedetomidine |
| Salinepatients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint. | Drug | Control |
Primary outcome
pain free time
Time frame: 48 hours
VAS
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 27 Jun 2017.
- Derived from this study: PubMed 29149146Moeen SM, Ramadan IK, Elkady HA. Dexamethasone and Dexmedetomidine as an Adjuvant to Intraarticular Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery: A Randomized Trial. Pain Physician. 2017 Nov;20(7):671-680.
- Individual participant dataSharing planned: Yes
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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.
Seham M Moeen, MD principal investigator
Assiut Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone, Dexmedetomidine and Saline 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 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 27 Jun 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
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?
pain free time (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818985, which also lists 1 linked publication.
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 27 Jun 2017; AzTrials last refreshed its copy on 3 Nov 2026.