Parecoxib for Treatment of Catheter Related Bladder Discomfort

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729935
• Other study ID #: University Of Tunis El Manar
• Status: Completed
• Phase: Phase 4
• First received: March 31, 2016
• Last updated: October 16, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adult (>/=18)

2. Male or female

3. Undergoing catheterization after transurethral resection of bladder tumor (TURBT)

4. Under spinal anesthesia

5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria:

1. Patient who disagrees to participate this investigation

2. Patient with severe cardiovascular disease

3. Patient with small-sized foley catheter (less than 18 Fr.)

4. Patinets with bladder outflow obstruction

5. Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h)

6. Patients with chronic renal failure

7. Patient with morbid obesity

8. Patient with medications for chronic pain

9. Patient with disturbance of the central nervous system

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Parecoxib
40 mg of intravenous parecoxib 30 min before surgery
• Placebo
An equal volume of saline

Locations

Country	Name	City	State
Tunisia	Ali JENDOUBI	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Severity of Pain at suprapubic area	Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)	at postoperative 0, 1, 6 and 12 hours	No
Secondary	safety and tolerability of parecoxib	Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events	During the first 24 hours	No