Total Knee ArthroplastyNCT06555458
The Effect of Sedation on Rebound Pain in Knee Arthroplasty
A study testing Dexmedetomidine and Saline in people with Total Knee Arthroplasty and Sedation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Sedation
- What is being tested?
- Dexmedetomidine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2023to 25 Jul 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.
Who cannot join
- Situations in which spinal anesthesia is contraindicated
- Advanced organ failure states(cardiac,hepatic,respiratuar or renal)
- Pregnancy
- BMI > 40 kg/m^2
- Do not want to participate in the study
- Younger than 18 or older than 85
- Have bilateral total knee arthroplasty or resurgery
- Develop an unexpected intraoperative surgical complication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, ÇANKAYA, 06800
About this study
Official title: The Effect of Sedation on Rebound Pain in Knee Arthrplasty Performed Under Spinal Anesthesia
Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores.
Read the detailed description
Randomization will take place before the patient enters the operating room. After spinal anesthesia is applied, 0.4 mcg/kg sedadomide loading will be done for 10 minutes in the sedation group, and then 0.4 mcg/kg/h sedadomide infusion will continue until the end of the surgery. Patients selected for the control group will be given the same amounts of saline. At the end of the surgical procedure, saline and sedadomide infusions will be stopped. All patients will undergo an adductor canal block under USG guidance in the recovery room. 50 mg of buvacin will be given to the block area. Patients will be fitted with a patient control analgesia device, which only provides bolus application and provides 20 mg of madol in each bolus. Postoperatively, sudden onset severe withdrawal pain outside the normal course of pain starting within 48 hours will be followed and Vas-bromage monitoring will be done at 0, 1, 2, 4, 8, 12, 24, 36, 48 hours.
- Conditions
- Total Knee Arthroplasty, Sedation
- Being tested
- Dexmedetomidine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patient group to be given dexmedetomidine
SalineDrug
Patient group to be given salin
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Patients will receive the standardized pre-op meds and spinal anesthetic.
Once the patient's spinal is performed, patient will receive the following:
Start with bolus of 0.4 microgram/kg over 10 minutes, and then infusion of 0.4 microgram/kg/hr infusion will be stopped after the last staple or suture is performed on the incision.
Interventions:
Drug: Dexmedetomidine Receives: Drug: Dexmedetomidine |
| Saline | Placebo comparator | Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.
Interventions:
Drug: Normal Saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound pain VAS scores and incidence of rebound pain
Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start19 Nov 2023
- Primary completion30 Mar 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555458
- Sponsor's protocol ID
- E1-23-4142
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sedation on Rebound Pain in Knee Arthrplasty Performed Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06555458
- Acronym / sponsor ID
- E1-23-4142
- Conditions
- Total Knee Arthroplasty, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 15 Aug 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.
Dexmedetomidine is often used for sedation procedures. It has also been shown to have a pain-protective effect. Researchers predicted that using dexmedetomidine for sedation in total knee arthroplasties performed under spinal anesthesia would reduce the frequency of rebound pain and pain scores.
Detailed description
Randomization will take place before the patient enters the operating room. After spinal anesthesia is applied, 0.4 mcg/kg sedadomide loading will be done for 10 minutes in the sedation group, and then 0.4 mcg/kg/h sedadomide infusion will continue until the end of the surgery. Patients selected for the control group will be given the same amounts of saline. At the end of the surgical procedure, saline and sedadomide infusions will be stopped. All patients will undergo an adductor canal block under USG guidance in the recovery room. 50 mg of buvacin will be given to the block area. Patients will be fitted with a patient control analgesia device, which only provides bolus application and provides 20 mg of madol in each bolus. Postoperatively, sudden onset severe withdrawal pain outside the normal course of pain starting within 48 hours will be followed and Vas-bromage monitoring will be done at 0, 1, 2, 4, 8, 12, 24, 36, 48 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidinePatients will receive the standardized pre-op meds and spinal anesthetic. Once the patient's spinal is performed, patient will receive the following: Start with bolus of 0.4 microgram/kg over 10 minutes, and then infusion of 0.4 microgram/kg/hr infusion will be stopped after the last staple or suture is performed on the incision. Interventions: Drug: Dexmedetomidine |
| Saline | Placebo comparator | Drug: SalinePatients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo. Interventions: Drug: Normal Saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Total Knee arthroplasty American Society of Anesthesiologist score of 1-3 Age 18-85 Elective total knee arthroplasty under spinal anesthetic.
Key exclusion criteria (8 listed)
- Situations in which spinal anesthesia is contraindicated
- Advanced organ failure states(cardiac,hepatic,respiratuar or renal)
- Pregnancy
- BMI > 40 kg/m^2
- Do not want to participate in the study
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 |
|---|---|---|
| DexmedetomidinePatient group to be given dexmedetomidine | Drug | Dexmedetomidine |
| SalinePatient group to be given salin | Drug | Saline |
Primary outcome
Rebound pain VAS scores and incidence of rebound pain
Time frame: 48 hours after surgery
Rebound pain-defined as transient acute postoperative pain within 12-24hrs that ensues following resolution of sensory blocked.
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 19 Aug 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 Saline in people with Total Knee Arthroplasty and Sedation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 8 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 19 Aug 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 Turkey (Türkiye). 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.
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?
Rebound pain VAS scores and incidence of rebound pain (time frame: 48 hours after surgery). 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 19 Aug 2024.