ArthroscopyPhase 4NCT03955809
Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.
A Phase 4 study testing Ketamine 0.5, Ketamine 1 and % 0.9 NaCl in people with Arthroscopy, run by Balikesir University.
Trial summary
the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroscopy
- What is being tested?
- Ketamine 0.5, Ketamine 1 and % 0.9 NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2016
- Phase
- Phase 4
- 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 75 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Artroscopic surgery
- ASA I-II
Who cannot join
- Long time NSAID use
- Travmatic knee injury
- Long ter analgesic use
- Intraartiular catheter insertion at the end of surgery
About this study
Official title: Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy
Read the detailed description
All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary.
Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine.
VAS scores and total analgesic requirement is going to be evaluated.
- Conditions
- Arthroscopy
- Being tested
- Ketamine 0.5, Ketamine 1, % 0.9 NaCl
- Keywords
- Injection, Intra-Articular, arthroscopy, ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 0.5Drug
Also called Group 1
İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml
Ketamine 1Drug
Also called Group 2
İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml
% 0.9 NaClDrug
Also called Group 3
Intraarticular %0.9 NaCl
| Study group | Role | What they receive |
|---|---|---|
| Ketamine 0.5 mg/kg | Active comparator | ketamin 0.5 mg/kg intraarticular Receives: Drug: Ketamine 0.5 |
| Ketamine 1 mg/kg | Active comparator | ketamin 1 mg/kg intraarticular injection Receives: Drug: Ketamine 1 |
| % 0.9 Saline | Sham comparator | % 0.9 NaCL intraarticular injection Receives: Drug: % 0.9 NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain scores throughout time evaluated by VAS
Pain scores are going to be evaluated by VAS scores at rest and VAS scores at activity
Measured: VAS scores at rest and during activity will be evaluated for 24 hours. The first measurement will be recorded immediately after surgery and at 30 minutes interval for the first hour. Afterwards at 2.4.6.12.24.hours postoperatively.
Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.
The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded.
Measured: Total amount off delivered morphine will be recorded for 24 hours.
Secondary outcomes (1)
Time for discharge measured by eligible for discharge criteria
The time needed to fullfill the dicharge criteria (stable vital signs, able to walk, able to eat, nausea and vomit free, able to mixture)
Measured: Discharge criterias will be evaluated every three hours until postoperative 24. hour. In patients who did not complete the discharge criteria in the postoperative 24 hours period, they will be defined as prolonged discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroscopyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sagir, MD, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955809
- Sponsor's protocol ID
- osagir3
- Status last verified
- Jan 2020
- First submitted
- 14 May 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for
- ClinicalTrials.gov ID
- NCT03955809
- Acronym / sponsor ID
- osagir3
- Conditions
- Arthroscopy
- Keywords
- Injection, Intra-Articular, arthroscopy, ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 May 2019 (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 is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy
Detailed description
All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary.
Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine.
VAS scores and total analgesic requirement is going to be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine 0.5 mg/kg | Active comparator | Drug: Ketamine 0.5ketamin 0.5 mg/kg intraarticular |
| Ketamine 1 mg/kg | Active comparator | Drug: Ketamine 1ketamin 1 mg/kg intraarticular injection |
| % 0.9 Saline | Sham comparator | Drug: % 0.9 NaCl% 0.9 NaCL intraarticular injection |
Who may qualify
- Ages
- 18 to 75 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Artroscopic surgery
- ASA I-II
Key exclusion criteria (4 listed)
- Long time NSAID use
- Travmatic knee injury
- Long ter analgesic use
- Intraartiular catheter insertion at the end of surgery
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 |
|---|---|---|
| Ketamine 0.5Also: Group 1İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml | Drug | Ketamine 0.5 mg/kg |
| Ketamine 1Also: Group 2İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml | Drug | Ketamine 1 mg/kg |
| % 0.9 NaClAlso: Group 3Intraarticular %0.9 NaCl | Drug | % 0.9 Saline |
Primary outcome
Change in postoperative pain scores throughout time evaluated by VAS
Time frame: VAS scores at rest and during activity will be evaluated for 24 hours. The first measurement will be recorded immediately after surgery and at 30 minutes interval for the first hour. Afterwards at 2.4.6.12.24.hours postoperatively.
Pain scores are going to be evaluated by VAS scores at rest and VAS scores at activity
Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.
Time frame: Total amount off delivered morphine will be recorded for 24 hours.
The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded.
1 secondary outcome
Time for discharge measured by eligible for discharge criteria
Time frame: Discharge criterias will be evaluated every three hours until postoperative 24. hour. In patients who did not complete the discharge criteria in the postoperative 24 hours period, they will be defined as prolonged discharge.
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 22 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine 0.5, Ketamine 1 and % 0.9 NaCl in people with Arthroscopy, run by Balikesir University.
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 4 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in postoperative pain scores throughout time evaluated by VAS (time frame: VAS scores at rest and during activity will be evaluated for 24 hours. The first measurement will be recorded immediately after surgery and at 30 minutes interval for the first hour. Afterwards at 2.4.6.12.24.hours postoperatively.). The study lists 2 primary outcomes in all. 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 22 Jan 2020.