Pregabalin on Catheter Related Bladder DiscomfortPhase 2/3NCT03232021

Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations

A Phase 2/3 study testing Pregabalin Oral Capsule [Lyrica] 75mg and Pregabalin Oral Capsule [Lyrica] 150 mg in people with Pregabalin on Catheter Related Bladder Discomfort, run by Saint Savvas Anticancer Hospital at 2 sites in Greece.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The aim of this study is to assess the effect of pregabalin administration on catheter-related bladder discomfort (CRBD). The study group includes patients that are about to be subjected to orthopedic operations. Read more about this study

Who is it for?: Ages 45 to 85 years
Conditions the study is for: Pregabalin on Catheter Related Bladder Discomfort
What is being tested?: Pregabalin Oral Capsule [Lyrica] 75mg and Pregabalin Oral Capsule [Lyrica] 150 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 2 sitesGreece
Study dates: 16 Aug 2017to 30 Apr 2019
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 45 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients about to be subjected to urinary operations
Signed informed consent

Who cannot join

Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology
History of overactive ((urinary frequency>3 times at night and >8 times in 24 hours), neurogenic bladder
End stage renal failure
Central nervous system dysfunction
Mental illness/ substance abuse
Sensitivity to pregabalin
Preoperative administration of pregabalin for other indications
Recent bladder catheterization <3 months

Trial locations and contacts

2 sites in 1 country.

Greece2 sites

Anticancer Hospital of Athens "Saint Savvas"
Athens, 115 22
University of Thessaly, Medical School
Volos, 38221

Other trials in Greece

About this study

Conditions: Pregabalin on Catheter Related Bladder Discomfort
Being tested: Placebo oral capsule, Pregabalin Oral Capsule [Lyrica] 75mg, Pregabalin Oral Capsule [Lyrica] 150 mg
Keywords: urinary bladder, urinary catheters, pregabalin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo oral capsuleDrug
Placebo oral capsule administered 1 hour prior to the surgical operation
Pregabalin Oral Capsule [Lyrica] 75mgDrug
Also called Pregabalin
Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation
Pregabalin Oral Capsule [Lyrica] 150 mgDrug
Also called Pregabalin
Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation

Study groups in NCT03232021
Study group	Role	What they receive
Group I	Placebo comparator	Administration of a placebo capsule 1 hour prior to the surgical operation Receives: Drug: Placebo oral capsule
Group II	Experimental	Administration of 75mg of pregabalin 1 hour prior to the surgical operation Receives: Drug: Pregabalin Oral Capsule [Lyrica] 75mg
Group III	Experimental	Administration of 150mg of pregabalin 1 hour prior to the surgical operation Receives: Drug: Pregabalin Oral Capsule [Lyrica] 150 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration
Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)
Measured: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively

Secondary outcomes (3)

Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)
The goal is to achieve pain scores<3 as these are assessed by the NPRS scale. In order to achieve that we will record the total amount of milligrams of analogues of morphine administered in the first 24 hours postoperatively
Measured: Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively
Adverse effects of the drug
Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness
Measured: All adverse effects observed in the first 24 hours postoperatively
Assessment of postoperative sedation
The Ramsay Sedation Scale is used to measure different levels of sedation in medical patients (1=Patient is anxious and agitated or restless, or both 2=Patient is co-operative, oriented, and tranquil, 3=Patient responds to commands only, 4=Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5=Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6=Patient exhibits no response)
Measured: In the operating theatre immediately after patient's extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 201730 Apr 2019

First posted27 Jul 2017
Study start16 Aug 2017
Primary completion31 Dec 2018 (estimated)
Study completion30 Apr 2019 (estimated)

Why it stopped: All patients during the study period were subjected to peripheral blocks or were excluded from the study due to exclusion criteria

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pregabalin on Catheter Related Bladder DiscomfortStudies 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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, double-blind,randomized, placebo controlled trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03232021
Sponsor's protocol ID: CRBD orthopedic operations
Status last verified: Mar 2020
First submitted: 25 Jul 2017
Last updated: 31 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
PubMed 16415311
Bai Y, Wang X, Li X, Pu C, Yuan H, Tang Y, Li J, Wei Q, Han P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J Endourol. 2015 Jun;29(6):640-9. doi: 10.1089/end.2014.0670. Epub 2014 Dec 9.
PubMed 25335575
Srivastava VK, Agrawal S, Kadiyala VN, Ahmed M, Sharma S, Kumar R. The efficacy of pregabalin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled double-blind study. J Anesth. 2015 Apr;29(2):212-6. doi: 10.1007/s00540-014-1911-x. Epub 2014 Sep 9.
PubMed 25200037

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations
ClinicalTrials.gov ID: NCT03232021
Acronym / sponsor ID: CRBD orthopedic operations
Conditions: Pregabalin on Catheter Related Bladder Discomfort
Keywords: urinary bladder, urinary catheters, pregabalin
Phase: Phase 2/3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: All patients during the study period were subjected to peripheral blocks or were excluded from the study due to exclusion criteria
Enrolment: 0 participants (actual)
Lead sponsor: Saint Savvas Anticancer HospitalUniversity, hospital or other
Collaborators: University of Thessaly
Study start: 16 Aug 2017 (actual)
Primary completion: 31 Dec 2018 (estimated)
Study completion: 30 Apr 2019 (estimated)
First posted: 27 Jul 2017 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Prospective, double-blind,randomized, placebo controlled trial

Arm	Type	Receives
Group I	Placebo comparator	Drug: Placebo oral capsuleAdministration of a placebo capsule 1 hour prior to the surgical operation
Group II	Experimental	Drug: Pregabalin Oral Capsule [Lyrica] 75mgAdministration of 75mg of pregabalin 1 hour prior to the surgical operation
Group III	Experimental	Drug: Pregabalin Oral Capsule [Lyrica] 150 mgAdministration of 150mg of pregabalin 1 hour prior to the surgical operation

Who may qualify

Ages: 45 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

All patients about to be subjected to urinary operations
Signed informed consent

Key exclusion criteria (8 listed)

Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology
History of overactive ((urinary frequency>3 times at night and >8 times in 24 hours), neurogenic bladder
End stage renal failure
Central nervous system dysfunction
Mental illness/ substance abuse

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
Placebo oral capsulePlacebo oral capsule administered 1 hour prior to the surgical operation	Drug	Group I
Pregabalin Oral Capsule [Lyrica] 75mgAlso: PregabalinPregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation	Drug	Group II
Pregabalin Oral Capsule [Lyrica] 150 mgAlso: PregabalinPregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation	Drug	Group III

Primary outcome

Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration
Time frame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)

3 secondary outcomes

Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)
Time frame: Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively
Adverse effects of the drug
Time frame: All adverse effects observed in the first 24 hours postoperatively
Assessment of postoperative sedation
Time frame: In the operating theatre immediately after patient's extubation

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Background: PubMed 16415311Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
Background: PubMed 25335575Bai Y, Wang X, Li X, Pu C, Yuan H, Tang Y, Li J, Wei Q, Han P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J Endourol. 2015 Jun;29(6):640-9. doi: 10.1089/end.2014.0670. Epub 2014 Dec 9.
Background: PubMed 25200037Srivastava VK, Agrawal S, Kadiyala VN, Ahmed M, Sharma S, Kumar R. The efficacy of pregabalin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled double-blind study. J Anesth. 2015 Apr;29(2):212-6. doi: 10.1007/s00540-014-1911-x. Epub 2014 Sep 9.
Individual participant dataSharing planned: Undecided

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.

Sofia Poulopoulou, Head of department study director

Anticancer Hospital of Athens 'Saint Savvas'

Eleni Arnaoutoglou, Professor of Anesthesiology study chair

University of Thessaly, Medical School, Anesthesiology Clinic

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: withdrawn, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. 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 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 was withdrawn before enrolling participants, so there are no results.

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?

Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration (time frame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively). 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 NCT03232021, which also lists 3 linked publications.

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 2020.