Postoperative PainPhase 4NCT02729935
Parecoxib for Treatment of Catheter Related Bladder Discomfort
A Phase 4 study testing Parecoxib in people with Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- Mar 2016to Jun 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>/=18)
- Male or female
- Undergoing catheterization after transurethral resection of bladder tumor (TURBT)
- Under spinal anesthesia
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Who cannot join
- Patient who disagrees to participate this investigation
- Patient with severe cardiovascular disease
- Patient with small-sized foley catheter (less than 18 Fr.)
- Patinets with bladder outflow obstruction
- Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h)
- Patients with chronic renal failure
Show all 9Show fewer
- Patient with morbid obesity
- Patient with medications for chronic pain
- Patient with disturbance of the central nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerance of Parecoxib for Prevention of Catheter-related Bladder Discomfort in Patients Undergoing Catheterization After TURBT: A Prospective, Randomized, Placebo-controlled, Double-blind Study
Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).
Read the detailed description
Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous parecoxib 30 min before surgery and Control Group C: an equal volume of saline.
Lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.
- Conditions
- Postoperative Pain
- Being tested
- Parecoxib, Placebo
- Keywords
- Parecoxib, Bladder Discomfort
- 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
Also called DYNASTAT
40 mg of intravenous parecoxib 30 min before surgery
PlaceboDrug
Also called Saline
An equal volume of saline
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib | Experimental | 40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery Receives: Drug: Parecoxib |
| Placebo | Placebo comparator | An equal volume of saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing of Catheter related bladder discomfort symptoms
CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.
Measured: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours
Secondary outcomes (2)
Severity of Pain at suprapubic area
Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)
Measured: at postoperative 0, 1, 6 and 12 hours
safety and tolerability of parecoxib
Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events
Measured: During the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali JENDOUBI, University Tunis El Manar
- Investigators
- Ali JENDOUBI, Principal investigator, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729935
- Sponsor's protocol ID
- University Of Tunis El Manar
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jendoubi A, Aissi W, Abbes A, Bouzouita A, Fourati S, Necib H, Ghedira S, Houissa M. Efficacy and safety of Parecoxib for prevention of catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: Prospective randomised trial. Indian J Anaesth. 2018 Jun;62(6):461-465. doi: 10.4103/ija.IJA_137_18.
PubMed 29962529
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of Parecoxib for Prevention of Catheter-related Bladder Discomfort in Patients Undergoing Catheterization After TURBT: A Prospective, Randomized, Placebo-controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT02729935
- Acronym / sponsor ID
- University Of Tunis El Manar
- Conditions
- Postoperative Pain
- Keywords
- Parecoxib, Bladder Discomfort
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Apr 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.
Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).
Detailed description
Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous parecoxib 30 min before surgery and Control Group C: an equal volume of saline.
Lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib | Experimental | Drug: Parecoxib40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery |
| Placebo | Placebo comparator | Drug: PlaceboAn equal volume of saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (>/=18)
- Male or female
- Undergoing catheterization after transurethral resection of bladder tumor (TURBT)
- Under spinal anesthesia
- Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.
Key exclusion criteria (9 listed)
- Patient who disagrees to participate this investigation
- Patient with severe cardiovascular disease
- Patient with small-sized foley catheter (less than 18 Fr.)
- Patinets with bladder outflow obstruction
- Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h)
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 |
|---|---|---|
| ParecoxibAlso: DYNASTAT40 mg of intravenous parecoxib 30 min before surgery | Drug | Parecoxib |
| PlaceboAlso: SalineAn equal volume of saline | Drug | Placebo |
Primary outcome
Reducing of Catheter related bladder discomfort symptoms
Time frame: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours
CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.
2 secondary outcomes
Severity of Pain at suprapubic area
Time frame: at postoperative 0, 1, 6 and 12 hours
safety and tolerability of parecoxib
Time frame: During the first 24 hours
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 18 Oct 2016.
- Derived from this study: PubMed 29962529Jendoubi A, Aissi W, Abbes A, Bouzouita A, Fourati S, Necib H, Ghedira S, Houissa M. Efficacy and safety of Parecoxib for prevention of catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: Prospective randomised trial. Indian J Anaesth. 2018 Jun;62(6):461-465. doi: 10.4103/ija.IJA_137_18.
- 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.
Ali JENDOUBI principal investigator
University Tunis El Manar
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 in people with Postoperative Pain, run by University Tunis El Manar at 1 site in Tunisia.
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 5 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 18 Oct 2016. 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 Tunisia. 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?
Reducing of Catheter related bladder discomfort symptoms (time frame: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729935, which also lists 1 linked publication.
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 18 Oct 2016.