Postoperative Pain ManagementPhase 4PCTKANCT01344213
Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine
A Phase 4 study testing Pregabalin, Celecoxib and Pregabalin with celecoxib in people with Postoperative Pain Management and Total Knee Arthroplasty, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management, Total Knee Arthroplasty
- What is being tested?
- Pregabalin, Celecoxib and Pregabalin with celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2008to Oct 2010
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 50-75 years of age
- Patients with an American Society of Anesthesiologists physical status of I to III
- Patients scheduled for primary TKA with a diagnosis of osteoarthritis under spinal anesthesia
Who cannot join
- Patients had a known allergy to any of the medications being used
- a history of drug or alcohol abuse
- a history of taking chronic pain medications (ie, show-release preparations of opioids, given that morphine consumption was the primary outcome)
- a history of taking pregabalin or gabapentin / non-steroidal anti-inflammatory drugs / COX-2 inhibitors
- a psychiatric disorder
- a history of impaired renal function (Cr > 1.5 mg/dl), peptic ulcer, asthma, thrombotic cerebrocardiovascular diseases, uncontrolled hypertension
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- a history of contraindication for spinal anesthesia
- a history of bleeding tendency
- pregnancy
- unable or unwilling to use patient - controlled analgesic (PCA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficacy Among Pregabalin, Celecoxib, Pregabalin With Celecoxib and Placebo After Total Knee Arthroplasty Under Intrathecal Morphine
To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty.
Read the detailed description
A single-dose spinal anesthesia combining with morphine for total knee arthroplasty (TKA) is a simple, economical anesthetic technique commonly used in our hospital. Still some patients could not get effective postoperative pain control. Pregabalin, an anticonvulsant, has been shown to reduce acute pain after molar extraction, laparoscopic cholecystectomy, and reduce postoperative morphine requirement after total hip arthroplasty, and celecoxib, a selective cyclo-oxygenase (COX) - 2 inhibitor, with perioperative prescription is successfully reduces pain score and opioid consumption after TKA under spinal anesthesia alone. However, no clinical study has yet investigated whether preoperative single-dose of pregabalin, celecoxib or in combination compared to placebo can improve analgesic efficacy of intrathecal morphine after TKA. The primary objective of this study was to evaluate whether these medications could reduce pain scores at rest / when movement and morphine requirement after TKA under spinal anesthesia with intrathecal morphine. Secondary outcome assessed include adverse effects, anxiety score and patients' satisfaction score.
- Being tested
- Pregabalin, Celecoxib, Pregabalin with celecoxib, Placebo
- Keywords
- Pregabalin, Celecoxib, Intrathecal morphine, Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Pregabalin: Lyrica
Oral single-dose of pregabalin (150 mg) and placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
CelecoxibDrug
Also called Celecoxib: Celebrex
Oral single-dose of celecoxib (400 mg) and placebo(C)1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
Pregabalin with celecoxibDrug
Also called Pregabalin: Lyrica, Celecoxib: Celebrex
Oral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
PlaceboDrug
Also called Placebo: sugar capsule
Oral single dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Oral single-dose of pregabalin (150 mg) and 1 capsule of placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. Receives: Drug: Pregabalin |
| Celecoxib | Active comparator | Oral single-dose of celecoxib (400 mg) and 1 capsule of placebo (C) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. Receives: Drug: Celecoxib |
| Pregabalin with celecoxib | Active comparator | Oral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. Receives: Drug: Pregabalin with celecoxib |
| Placebo | Placebo comparator | Oral single-dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour cumulative morphine consumption
- The time to first morphine requirement will be recorded
- The cumulative morphine consumption will be recorded at the end of surgery and 2-h, 6-h, 10-h, 24-h, and 48-h postoperatively
- Visual analog scale (VAS) pain scores at rest will be assessed at the night before surgical date, before starting anesthesia, at the end of surgery, and 2-h, 6-h, 10-h, 24-h and 48-h postoperatively
- Visual analog scale (VAS) pain scores when on movement will be assessed at the end of surgery, and 2-h, 6-h, 10-h, 24-h and 48-h postoperatively
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (1)
Anxiety scores (VAS), patients' satisfaction
- Anxiety scores will be assessed at the night before surgical date, before starting anesthesia, at the end of surgery, and 2-h, 6-h, 10-h, 24-h and 48-h postoperatively;
- 24-h and 48-h patients' satisfaction (0-10,0=dissatisfied and 10= very satisfied)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJul 2008
- Primary completionOct 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Bhumibol Adulyadej Hospital, King Chulalongkorn Memorial Hospital
- Investigators
- Supranee Niruthisard, BSc, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344213
- Sponsor's protocol ID
- anesTKA08
- Acronym
- PCTKA
- Status last verified
- Apr 2011
- First submitted
- 26 Apr 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy Among Pregabalin, Celecoxib, Pregabalin With Celecoxib and Placebo After Total Knee Arthroplasty Under Intrathecal Morphine
- ClinicalTrials.gov ID
- NCT01344213
- Acronym / sponsor ID
- PCTKA / anesTKA08
- Keywords
- Pregabalin, Celecoxib, Intrathecal morphine, Total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Bhumibol Adulyadej Hospital, King Chulalongkorn Memorial Hospital
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Apr 2011 (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.
To evaluate whether pregabalin and/or celecoxib could improve analgesic efficacy of intrathecal morphine for patients after total knee arthroplasty.
Detailed description
A single-dose spinal anesthesia combining with morphine for total knee arthroplasty (TKA) is a simple, economical anesthetic technique commonly used in our hospital. Still some patients could not get effective postoperative pain control. Pregabalin, an anticonvulsant, has been shown to reduce acute pain after molar extraction, laparoscopic cholecystectomy, and reduce postoperative morphine requirement after total hip arthroplasty, and celecoxib, a selective cyclo-oxygenase (COX) - 2 inhibitor, with perioperative prescription is successfully reduces pain score and opioid consumption after TKA under spinal anesthesia alone. However, no clinical study has yet investigated whether preoperative single-dose of pregabalin, celecoxib or in combination compared to placebo can improve analgesic efficacy of intrathecal morphine after TKA. The primary objective of this study was to evaluate whether these medications could reduce pain scores at rest / when movement and morphine requirement after TKA under spinal anesthesia with intrathecal morphine. Secondary outcome assessed include adverse effects, anxiety score and patients' satisfaction score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: PregabalinOral single-dose of pregabalin (150 mg) and 1 capsule of placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. |
| Celecoxib | Active comparator | Drug: CelecoxibOral single-dose of celecoxib (400 mg) and 1 capsule of placebo (C) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. |
| Pregabalin with celecoxib | Active comparator | Drug: Pregabalin with celecoxibOral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. |
| Placebo | Placebo comparator | Drug: PlaceboOral single-dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 50-75 years of age
- Patients with an American Society of Anesthesiologists physical status of I to III
- Patients scheduled for primary TKA with a diagnosis of osteoarthritis under spinal anesthesia
Key exclusion criteria (10 listed)
- Patients had a known allergy to any of the medications being used
- a history of drug or alcohol abuse
- a history of taking chronic pain medications (ie, show-release preparations of opioids, given that morphine consumption was the primary outcome)
- a history of taking pregabalin or gabapentin / non-steroidal anti-inflammatory drugs / COX-2 inhibitors
- a psychiatric disorder
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: Pregabalin: LyricaOral single-dose of pregabalin (150 mg) and placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. | Drug | Pregabalin |
| CelecoxibAlso: Celecoxib: CelebrexOral single-dose of celecoxib (400 mg) and placebo(C)1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. | Drug | Celecoxib |
| Pregabalin with celecoxibAlso: Pregabalin: Lyrica, Celecoxib: CelebrexOral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg. | Drug | Pregabalin with celecoxib |
| PlaceboAlso: Placebo: sugar capsuleOral single dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg | Drug | Placebo |
Primary outcome
24-hour cumulative morphine consumption
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
* The time to first morphine requirement will be recorded * The cumulative morphine consumption will be recorded at the end of surgery and 2-h, 6-h, 10-h, 24-h, and 48-h postoperatively * Visual analog scale (VAS) pain scores at rest will be assessed at the night before surgical date, before starting anesthesia, at the end of surgery, and 2-h, 6-h, 10-h, 24-h and 48-h postoperatively * Visual analog scale (VAS) pain scores when on movement will be assessed at the end of surgery, and 2-h, 6-h, 10-h, 24-h and 48-h postoperatively
1 secondary outcome
Anxiety scores (VAS), patients' satisfaction
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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 4 Aug 2011.
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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.
Supranee Niruthisard, BSc, MD principal investigator
King Chulalongkorn Memorial 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, Celecoxib and Pregabalin with celecoxib in people with Postoperative Pain Management and Total Knee Arthroplasty, run by Chulalongkorn University at 1 site in Thailand.
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 10 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 4 Aug 2011. 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 Thailand. 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?
24-hour cumulative morphine consumption (time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 4 Aug 2011.