Preemptive AnalgesiaPhase 4NCT06140238
Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological Surgery
A Phase 4 study testing Parecoxib and Normal saline in people with Preemptive Analgesia and Gynecological Surgery, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
The research is to test the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery by comparing Parecoxib drug and NSS administration 15 min before starting the surgery which the result of postoperative pain score is interpret by visual analog scale index Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preemptive Analgesia, Gynecological Surgery, Postoperative Pain
- What is being tested?
- Parecoxib and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteThailand
- Study dates
- 10 Sep 2023to 27 Jun 2024
- 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 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients age between 18-70 year-old, who participate in explor lap gynecological surgery (Hysterectomy, Adnexal surgery and surgical stagings) using general anesthesia technique
- American society of Anesthesiologists physical status grade I-II
- Capable to communicate in Thai language
Who cannot join
- Allergic to NSAIDs and opioid
- Allergic to Parecoxib drug
- Underlying neuropathic pain
- Pregnant woman or woman who undergoes breast feeding
- Uncontrolled hypertension disease, BP >160/110 at admission date
- Underlying ischemic heart disease, Ischemic stroke or peripheral arterial disease
Show all 10Show fewer
- History status post coronary artery bypass grafting
- Patients who take Aspirin within 7 days before surgery date
- Had underlying which is contraindiated to NSAIDs drug such as Gastritis, history of GI ulcer, chronic kidney disease (Cr clearance < 30ml/min), liver cirrhosis (Child-Pugh class B or above/ serum albumin < 25 g/l)
- Patients who had NSAIDs drug while admit in hospital for preparing the operation before surgery date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological
The research is to test the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery by comparing Parecoxib drug and NSS administration 15 min before starting the surgery which the result of postoperative pain score is interpret by visual analog scale index
Read the detailed description
The research is working on testing the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery whether its can reduce postoperative pain score, reduce total opioid consumption in first 24 hour postoperation and reduce postoperation hospital length stay. Patients who are undergoing gynecological surgery is recruited to the research project while they admit in the hospital for preoperative preparation, in each type of surgery groups (1.Total abdominal hysterectomy 2. Adnexal surgery 3. Surgical staging) will divided in to 2 groups which is experimental group (Parecoxib) and control group (Normal saline). The experimental group will have Parecoxib administration 15 min before starting the surgery and control group will have normal saline administration 15 min before starting the surgery as same, the primary result is postoperative pain score which is interpreted by Visual analog scale index at 2,6,12,24 hour postoperation, the patients will get opioid drug (Morphine) for pain control depending on pain score index they inform, if pain score >7: morphine 0.075 mg/kg iv, if pain score 5 : morphine 0.05mg/kg iv, if pain score <5 : no morphine given. Lastly the side effect of Parecoxib drug will be observed and postoperative hospital length stay of each patient will be recorded
- Being tested
- Parecoxib, Normal saline
- Keywords
- Preemptive analgesia, Gynecological surgery, Parecoxib, 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.
ParecoxibDrug
Parecoxib administration 15 minutes before start surgical operation
Normal salineDrug
Normal saline administration 15 minutes before start surgical operation
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Groups of patients who have Parecoxib drug administration before start surgery Receives: Drug: Parecoxib |
| Control group | Placebo comparator | Group of patients who have normal saline (Placebo) administration before start surgery Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain score
Post operative pain score at 2,6,12,24 hr, described by 'Visual analog pain scale'
Measured: 24 hour post operation
Secondary outcomes (1)
Total dose of opioid drug consumption
Total dose of opioid drug consumption (Morphine) in 24 hour post operation
Measured: 24 hour post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 Sep 2023
- Primary completion27 Apr 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preemptive AnalgesiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140238
- Sponsor's protocol ID
- 113/2566
- Status last verified
- Aug 2023
- First submitted
- 28 Aug 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: drafting official document and distribute to IPD about study protocal, statistical analysis plan. inform consent and clinical study report
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesic Efficacy of Parecoxib for Reducing Postoperative Pain in Gynecological
- ClinicalTrials.gov ID
- NCT06140238
- Acronym / sponsor ID
- 113/2566
- Keywords
- Preemptive analgesia, Gynecological surgery, Parecoxib, Postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 27 Apr 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 18 Nov 2023 (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 research is to test the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery by comparing Parecoxib drug and NSS administration 15 min before starting the surgery which the result of postoperative pain score is interpret by visual analog scale index
Detailed description
The research is working on testing the preemptive analgesic efficacy of Parecoxib drug in gynecological surgery whether its can reduce postoperative pain score, reduce total opioid consumption in first 24 hour postoperation and reduce postoperation hospital length stay. Patients who are undergoing gynecological surgery is recruited to the research project while they admit in the hospital for preoperative preparation, in each type of surgery groups (1.Total abdominal hysterectomy 2. Adnexal surgery 3. Surgical staging) will divided in to 2 groups which is experimental group (Parecoxib) and control group (Normal saline). The experimental group will have Parecoxib administration 15 min before starting the surgery and control group will have normal saline administration 15 min before starting the surgery as same, the primary result is postoperative pain score which is interpreted by Visual analog scale index at 2,6,12,24 hour postoperation, the patients will get opioid drug (Morphine) for pain control depending on pain score index they inform, if pain score >7: morphine 0.075 mg/kg iv, if pain score 5 : morphine 0.05mg/kg iv, if pain score <5 : no morphine given. Lastly the side effect of Parecoxib drug will be observed and postoperative hospital length stay of each patient will be recorded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: ParecoxibGroups of patients who have Parecoxib drug administration before start surgery |
| Control group | Placebo comparator | Drug: Normal salineGroup of patients who have normal saline (Placebo) administration before start surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients age between 18-70 year-old, who participate in explor lap gynecological surgery (Hysterectomy, Adnexal surgery and surgical stagings) using general anesthesia technique
- American society of Anesthesiologists physical status grade I-II
- Capable to communicate in Thai language
Key exclusion criteria (10 listed)
- Allergic to NSAIDs and opioid
- Allergic to Parecoxib drug
- Underlying neuropathic pain
- Pregnant woman or woman who undergoes breast feeding
- Uncontrolled hypertension disease, BP >160/110 at admission date
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 |
|---|---|---|
| ParecoxibParecoxib administration 15 minutes before start surgical operation | Drug | Experimental group |
| Normal salineNormal saline administration 15 minutes before start surgical operation | Drug | Control group |
Primary outcome
Post operative pain score
Time frame: 24 hour post operation
Post operative pain score at 2,6,12,24 hr, described by 'Visual analog pain scale'
1 secondary outcome
Total dose of opioid drug consumption
Time frame: 24 hour post operation
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 14 Nov 2024.
- Individual participant dataSharing planned: Yes. drafting official document and distribute to IPD about study protocal, statistical analysis plan. inform consent and clinical study report
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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 Phase 4 study testing Parecoxib and Normal saline in people with Preemptive Analgesia and Gynecological Surgery, run by Department of Medical Services Ministry of Public Health of Thailand 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 14 Nov 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 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?
Post operative pain score (time frame: 24 hour post operation). 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 14 Nov 2024.