Laparoscopic Nissen FundoplicationPhase 4NCT01558622
Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
A Phase 4 study testing dexketoprofen trometamol, tramadol hydrochloride and pethidine hydrochloride in people with Laparoscopic Nissen Fundoplication, run by Kavaklıdere Umut Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Laparoscopic Nissen Fundoplication
- What is being tested?
- dexketoprofen trometamol, tramadol hydrochloride and pethidine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to May 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old ASA I-II patients
- Clinical diagnosis of gastroesophageal reflux patients
Who cannot join
- Allergic reactions to NSAIDs or opioid analgesics
- Body mass index exceeding 35
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.
- Conditions
- Laparoscopic Nissen Fundoplication
- Being tested
- dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride, dexketoprofen trometamol + tramadol hydrochloride, dexketoprofen trometamol + pethidine hydrochloride
- Keywords
- postoperative analgesia, dexketoprofen trometamol, tramadol hydrochloride, pethidine, laparoscopic Nissen fundoplication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexketoprofen trometamolDrug
50mg intravenous infusion
tramadol hydrochlorideDrug
100mg intravenous infusion
pethidine hydrochlorideDrug
50mg intravenous infusion
dexketoprofen trometamol + tramadol hydrochlorideDrug
intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride
dexketoprofen trometamol + pethidine hydrochlorideDrug
intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride
vitamin cDrug
500mg intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| dexketoprofen trometamol | Placebo comparator | Dexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen. Receives: Drug: dexketoprofen trometamol |
| tramadol hydrochloride | Placebo comparator | Tramadol Hydrochloride is a well-known centrally acting opioid pain killer. Receives: Drug: tramadol hydrochloride |
| pethidine hydrochloride | Placebo comparator | Pethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared. Receives: Drug: pethidine hydrochloride |
| dexketoprofen trometamol + tramadol hydrochloride | Placebo comparator | Not described Receives: Drug: dexketoprofen trometamol + tramadol hydrochloride |
| dexketoprofen trometamol + pethidine hydrochloride | Placebo comparator | Not described Receives: Drug: dexketoprofen trometamol + pethidine hydrochloride |
| vitamin c | Placebo comparator | Not described Receives: Drug: vitamin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
Measured: postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Nissen FundoplicationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kavaklıdere Umut Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GOKHAN GOKMEN, Kavaklıdere Umut Hospital
- Investigators
- GOKHAN GOKMEN, Specialist, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558622
- Sponsor's protocol ID
- KVDU 0001 GG
- Status last verified
- Mar 2012
- First submitted
- 16 Mar 2012
- Last updated
- 23 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Dexketoprofen Trometamol, Tramadol Hcl, Pethidine Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
- ClinicalTrials.gov ID
- NCT01558622
- Acronym / sponsor ID
- KVDU 0001 GG
- Conditions
- Laparoscopic Nissen Fundoplication
- Keywords
- postoperative analgesia, dexketoprofen trometamol, tramadol hydrochloride, pethidine, laparoscopic Nissen fundoplication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Kavaklıdere Umut HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2012 (estimated)
- First posted
- 20 Mar 2012 (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.
The purpose of this study is to evaluate the analgesic effects of dexketoprofen trometamol, tramadol hydrochloride, pethidine hydrochloride and their combinations in laparoscopic Nissen fundoplication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| dexketoprofen trometamol | Placebo comparator | Drug: dexketoprofen trometamolDexketoprofen trometamol is a water-soluble salt of the dextrorotatory enantiomer of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen. |
| tramadol hydrochloride | Placebo comparator | Drug: tramadol hydrochlorideTramadol Hydrochloride is a well-known centrally acting opioid pain killer. |
| pethidine hydrochloride | Placebo comparator | Drug: pethidine hydrochloridePethidine is a synthetic opioid analgesic which produces a pattern of effects similar to morphine the standard against which opioid analgesics are compared. |
| dexketoprofen trometamol + tramadol hydrochloride | Placebo comparator | Drug: dexketoprofen trometamol + tramadol hydrochloride |
| dexketoprofen trometamol + pethidine hydrochloride | Placebo comparator | Drug: dexketoprofen trometamol + pethidine hydrochloride |
| vitamin c | Placebo comparator | Drug: vitamin c |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-60 years old ASA I-II patients
- Clinical diagnosis of gastroesophageal reflux patients
Key exclusion criteria (3 listed)
- Allergic reactions to NSAIDs or opioid analgesics
- Body mass index exceeding 35
- Pregnancy
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 |
|---|---|---|
| dexketoprofen trometamol50mg intravenous infusion | Drug | dexketoprofen trometamol |
| tramadol hydrochloride100mg intravenous infusion | Drug | tramadol hydrochloride |
| pethidine hydrochloride50mg intravenous infusion | Drug | pethidine hydrochloride |
| dexketoprofen trometamol + tramadol hydrochlorideintravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride | Drug | dexketoprofen trometamol + tramadol hydrochloride |
| dexketoprofen trometamol + pethidine hydrochlorideintravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride | Drug | dexketoprofen trometamol + pethidine hydrochloride |
| vitamin c500mg intravenous infusion | Drug | vitamin c |
Primary outcome
Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35
Time frame: postoperative 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2012.
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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.
GOKHAN GOKMEN, Specialist principal investigator
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 dexketoprofen trometamol, tramadol hydrochloride and pethidine hydrochloride in people with Laparoscopic Nissen Fundoplication, run by Kavaklıdere Umut Hospital 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2012. 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.
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?
Results are not available in the source record.
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?
Allergic reactions to NSAIDs or opioid analgesics, body mass index exceeding 35 (time frame: postoperative 2 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 23 Mar 2012.