NCT02729935

Brief 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. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

March 31, 2016

Last Update Submit

October 16, 2016

Conditions

Postoperative Pain

Keywords

ParecoxibBladder Discomfort

Outcome Measures

Primary Outcomes (1)

  • 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.

    at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours

Secondary Outcomes (2)

  • Severity of Pain at suprapubic area

    at postoperative 0, 1, 6 and 12 hours

  • safety and tolerability of parecoxib

    During the first 24 hours

Study Arms (2)

Parecoxib

EXPERIMENTAL

40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery

Drug: Parecoxib

Placebo

PLACEBO COMPARATOR

An equal volume of saline

Drug: Placebo

Interventions

ParecoxibDRUG

40 mg of intravenous parecoxib 30 min before surgery

Also known as: DYNASTAT
Parecoxib
PlaceboDRUG

An equal volume of saline

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Patient with morbid obesity
  • Patient with medications for chronic pain
  • Patient with disturbance of the central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ali JENDOUBI

Tunis, Tunis Governorate, 1006, Tunisia

Location

Related Publications (1)

  • 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.

    PMID: 29962529DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

parecoxibSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ali JENDOUBI

    University Tunis El Manar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 6, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)