Back to results

Parecoxib for Treatment of Catheter Related Bladder Discomfort

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Tunisia

Study Type

Interventional

Intervention

Parecoxib

Placebo

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Parecoxib, Bladder Discomfort

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Ali JENDOUBI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parecoxib

Placebo

Arm Description

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

An equal volume of saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Severity of Pain at suprapubic area

Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)

safety and tolerability of parecoxib

Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events

Full Information

NCT ID

NCT02729935

First Posted

March 31, 2016

Last Updated

October 16, 2016

Sponsor

University Tunis El Manar

1. Study Identification

Unique Protocol Identification Number

NCT02729935

Brief Title

Parecoxib for Treatment of Catheter Related Bladder Discomfort

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Tunis El Manar

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Parecoxib, Bladder Discomfort

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parecoxib

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

An equal volume of saline

Intervention Type

Drug

Intervention Name(s)

Parecoxib

Other Intervention Name(s)

DYNASTAT

Intervention Description

40 mg of intravenous parecoxib 30 min before surgery

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline

Intervention Description

An equal volume of saline

Primary Outcome Measure Information:

Title

Reducing of Catheter related bladder discomfort symptoms

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Severity of Pain at suprapubic area

Description

Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)

Time Frame

at postoperative 0, 1, 6 and 12 hours

Title

safety and tolerability of parecoxib

Description

Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events

Time Frame

During the first 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ali JENDOUBI

Organizational Affiliation

University Tunis El Manar

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ali JENDOUBI

City

Tunis

ZIP/Postal Code

1006

Country

Tunisia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29962529

Citation

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.

Results Reference

derived

Learn more about this trial

Parecoxib for Treatment of Catheter Related Bladder Discomfort

We'll reach out to this number within 24 hrs