Pain, PostoperativePhase 4NCT03512574
Combination Effects of Pregabalin and Dexmedetomidine on Postoperative Pain
A Phase 4 study testing Pregabalin, Dexmedetomidine and Pregabalin and dexmedetomidine in people with Pain, Postoperative, run by Wonkwang University Hospital at 1 site in South Korea.
Trial summary
Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pregabalin, Dexmedetomidine and Pregabalin and dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2018to 30 Mar 2018
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II
- Aged 18-75 years
- One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia
Who cannot join
- Pregnant
- Allergic and/or contraindicated to the study drugs
- American Society of Anesthesiologists (ASA) score III and above
- Having drug
- Alcohol addiction
- Renal failure
Show all 9Show fewer
- Diabetes mellitus
- Epilepsy
- currently using opioids for chronic pain and/or any of the drugs studied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Combination of Pregabalin and Dexmedetomidine on the Management of Postoperative Pain in Patients Undergoing Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) Under Spinal Anesthesia
Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia
Read the detailed description
One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33, pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31, dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. Clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (VAS), ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.
- Conditions
- Pain, Postoperative
- Being tested
- Pregabalin, Dexmedetomidine, Placebo, Pregabalin and dexmedetomidine
- Keywords
- pregabalin, dexmedetomidine, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
One hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery
DexmedetomidineDrug
Also called precedex
One hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery
PlaceboOther
One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery
Pregabalin and dexmedetomidineDrug
Also called study drugs
One hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group PD | Experimental | combination of pregabalin and dexmedetomidine Receives: Drug: Pregabalin and dexmedetomidine |
| Group P | Active comparator | pregabalin +placebo Receives: Drug: Pregabalin |
| Group D | Active comparator | placebo + dexmedetomidine Receives: Drug: Dexmedetomidine |
| Group C | Placebo comparator | placebo + placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient controlled analgesics (PCA) volume
Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery
Measured: For 24 hours
Secondary outcomes (4)
time to first analgesic request
time to first analgesic request for 24 hours after surgery
Measured: for 24 hours
visual analog scale (VAS)
The VAS consisted of a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain. Patients were asked to mark the position on the line corresponding to their perception of pain. The VAS scores for pain at rest and on movement were measured at intervals of 24, and 48 hours after surgery
Measured: for 24 hours
ketorolac dose
ketorolac dose for 24 hours after surgery
Measured: for 24 hours
adverse effects
Perioperative adverse effects Shivering, blurred vision, headache, dizziness, dry mouth, nausea/vomiting during the first 24 hours postoperatively
Measured: within the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start2 Jan 2018
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee, Wonkwang University Hospital
- Investigators
- Gilho Lee, M.D., Principal investigator, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512574
- Sponsor's protocol ID
- WonkwangUH5
- Status last verified
- Apr 2018
- First submitted
- 8 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Combination of Pregabalin and Dexmedetomidine on the Management of Postoperative Pain in Patients Undergoing Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03512574
- Acronym / sponsor ID
- WonkwangUH5
- Conditions
- Pain, Postoperative
- Keywords
- pregabalin, dexmedetomidine, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 1 May 2018 (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.
Pregabalin and dexmedetomidine have been introduced to manage postoperative pain. The present study aimed to evaluate the effect of the combination of two drugs on pain relief in patients undergoing total knee or hip arthroplasty under spinal anesthesia
Detailed description
One hundred and twenty-four patients undergoing total knee or hip arthroplasty under spinal anesthesia were randomly assigned to either group C (n = 31, placebo), group P (n = 33, pregabalin), group PD (n = 29, pregabalin and dexmedetomidine) or group D (n = 31, dexmedetomidine). One hour before spinal anesthesia, patients received pregabalin 150 mg or placebo orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, followed by a continuous infusion of 0.5 μg/kg/hr or the same calculated volume of normal saline till completion of the surgery. Clinically relevant pain for 24 h after surgery including time to first analgesic request visual analog scale (VAS), ketorolac dose, and patient controlled analgesics (PCA) volume consumed were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group PD | Experimental | Drug: Pregabalin and dexmedetomidinecombination of pregabalin and dexmedetomidine |
| Group P | Active comparator | Drug: Pregabalinpregabalin +placebo |
| Group D | Active comparator | Drug: Dexmedetomidineplacebo + dexmedetomidine |
| Group C | Placebo comparator | Other: Placeboplacebo + placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II
- Aged 18-75 years
- One hundred and twenty-four patients with intact cognitive function to understand this study undergoing elective total knee or hip arthroplasty under spinal anesthesia
Key exclusion criteria (9 listed)
- Pregnant
- Allergic and/or contraindicated to the study drugs
- American Society of Anesthesiologists (ASA) score III and above
- Having drug
- Alcohol addiction
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 |
|---|---|---|
| PregabalinAlso: LyricaOne hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery | Drug | Group P |
| DexmedetomidineAlso: precedexOne hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery | Drug | Group D |
| PlaceboOne hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery | Other | Group C |
| Pregabalin and dexmedetomidineAlso: study drugsOne hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery. | Drug | Group PD |
Primary outcome
Patient controlled analgesics (PCA) volume
Time frame: For 24 hours
Patient controlled analgesics (PCA) volume consumed for 24 hours after surgery
4 secondary outcomes
time to first analgesic request
Time frame: for 24 hours
visual analog scale (VAS)
Time frame: for 24 hours
ketorolac dose
Time frame: for 24 hours
adverse effects
Time frame: within the first 24 hours postoperatively
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 1 May 2018.
- 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.
Gilho Lee, M.D. principal investigator
Wonkwang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin, Dexmedetomidine and Pregabalin and dexmedetomidine in people with Pain, Postoperative, run by Wonkwang University Hospital at 1 site in South Korea.
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 3 inclusion and 9 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 1 May 2018. 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 South Korea. 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 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?
Patient controlled analgesics (PCA) volume (time frame: For 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 1 May 2018.