Parecoxib for Treatment of Catheter Related Bladder Discomfort

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Placebo; Drug: Parecoxib

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1006
    • Ali JENDOUBI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; An equal volume of saline	Drug: Placebo; An equal volume of saline; Other Names: Saline
Experimental: Parecoxib; 40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery	Drug: Parecoxib; 40 mg of intravenous parecoxib 30 min before surgery; Other Names: DYNASTAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
safety and tolerability of parecoxib	Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events	During the first 24 hours

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Principal Investigator: Ali JENDOUBI, University Tunis El Manar

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 16, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Parecoxib; Bladder Discomfort
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Parecoxib
• Other Study ID Numbers: University Of Tunis El Manar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO