Postoperative Pain Following Radical CystectomyPhase 2/3NCT02724293
Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy
A Phase 2/3 study testing pregabaline 300 mg once., pregabaline 300 mg twice. and pregabaline 600 mg once. in people with Postoperative Pain Following Radical Cystectomy, run by Assiut University.
Trial summary
This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain Following Radical Cystectomy
- What is being tested?
- pregabaline 300 mg once., pregabaline 300 mg twice. and pregabaline 600 mg once.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Nov 2015
- Phase
- Phase 2/3
- 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
- Sixty patients between the ages of 18 and 60 years.
- American Society of Anesthesiologists (ASA) I-II physical status.
- undergoing radical cystectomy under general anesthesia.
Who cannot join
- Patients with a history of drug or alcohol abuse.
- patients with chronic pain or daily intake of analgesics.
- uncontrolled diabetes mellitus.
- uncontrolled hypertension.
- atherosclerotic heart disease.
- seizures.
Show all 9Show fewer
- impaired kidney or liver functions,
- patients with body mass index ≥35 kg/m2, and whom
- patients that could not control a patient controlled analgesia (PCA) device.
About this study
Official title: Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial
This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.
- Being tested
- pregabaline 300 mg once., pregabaline 300 mg twice., pregabaline 600 mg once., placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabaline 300 mg once.Drug
patients received pregabaline 300 mg 2 hours pre-operatively.
pregabaline 300 mg twice.Drug
patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.
pregabaline 600 mg once.Drug
patients received pregabaline 600 mg 2 hours pre-operatively.
placeboDrug
patients received placebo
| Study group | Role | What they receive |
|---|---|---|
| Group I (placebo) | Placebo comparator | patients received placebo. Receives: Drug: placebo |
| Group II (pregabaline 300 once) | Active comparator | patients received pregabalin 300 mg 2 hours preoperatively. Receives: Drug: pregabaline 300 mg once. |
| Group III (pregabaline 300 twice) | Active comparator | patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose. Receives: Drug: pregabaline 300 mg twice. |
| Group IV (pregabaline 600) | Active comparator | patients received pregabalin 600 mg 2 hours preoperatively Receives: Drug: pregabaline 600 mg once. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS) score
analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours.
Measured: 24 hours postoperatively
postoperative opioid consumption
ability of study drugs to reduce the postoperative opioid analgesic consumption.
Measured: 24 hours postoperatively
time to first request of opioid analgesia
ability of the study drugs to delay the request of rescue opioid analgesia.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Safety assessed by incidence of side effects
represented by the incidence of side effects during the follow up period of 24 hours.
Measured: 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 posted31 Mar 2016 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Following Radical CystectomyStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Abd El-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724293
- Sponsor's protocol ID
- 266
- Status last verified
- Mar 2016
- First submitted
- 25 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT02724293
- Acronym / sponsor ID
- 266
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 Mar 2016 (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.
This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (placebo) | Placebo comparator | Drug: placebopatients received placebo. |
| Group II (pregabaline 300 once) | Active comparator | Drug: pregabaline 300 mg once.patients received pregabalin 300 mg 2 hours preoperatively. |
| Group III (pregabaline 300 twice) | Active comparator | Drug: pregabaline 300 mg twice.patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose. |
| Group IV (pregabaline 600) | Active comparator | Drug: pregabaline 600 mg once.patients received pregabalin 600 mg 2 hours preoperatively |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sixty patients between the ages of 18 and 60 years.
- American Society of Anesthesiologists (ASA) I-II physical status.
- undergoing radical cystectomy under general anesthesia.
Key exclusion criteria (9 listed)
- Patients with a history of drug or alcohol abuse.
- patients with chronic pain or daily intake of analgesics.
- uncontrolled diabetes mellitus.
- uncontrolled hypertension.
- atherosclerotic heart disease.
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 |
|---|---|---|
| pregabaline 300 mg once.patients received pregabaline 300 mg 2 hours pre-operatively. | Drug | Group II (pregabaline 300 once) |
| pregabaline 300 mg twice.patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later. | Drug | Group III (pregabaline 300 twice) |
| pregabaline 600 mg once.patients received pregabaline 600 mg 2 hours pre-operatively. | Drug | Group IV (pregabaline 600) |
| placebopatients received placebo | Drug | Group I (placebo) |
Primary outcome
visual analogue scale (VAS) score
Time frame: 24 hours postoperatively
analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours.
postoperative opioid consumption
Time frame: 24 hours postoperatively
ability of study drugs to reduce the postoperative opioid analgesic consumption.
time to first request of opioid analgesia
Time frame: 24 hours postoperatively
ability of the study drugs to delay the request of rescue opioid analgesia.
1 secondary outcome
Safety assessed by incidence of side effects
Time frame: 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 31 Mar 2016.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing pregabaline 300 mg once., pregabaline 300 mg twice. and pregabaline 600 mg once. in people with Postoperative Pain Following Radical Cystectomy, run by Assiut University.
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 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
visual analogue scale (VAS) score (time frame: 24 hours postoperatively). The study lists 3 primary outcomes in all. 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 31 Mar 2016.