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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parecoxib | Experimental | 40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery |
|
| Placebo | Placebo Comparator | An equal volume of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parecoxib | Drug | 40 mg of intravenous parecoxib 30 min before surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali JENDOUBI | University Tunis El Manar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ali JENDOUBI | Tunis | Tunis Governorate | 1006 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29962529 | Derived | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | An equal volume of saline |
|
|
Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events
| During the first 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D017670 |
| Sodium Compounds |