NCT06346522

Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU

Efficacy of Gabapentin Versus Trospium Chloride for Prevention of Catheter-related Bladder Discomfort (CRBD) Inside the Intensive Care Unit (ICU): a Prospective, Randomized,Comparative Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder.

Detailed description

* Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt * After satisfactory pain control and full recovery in the postanesthesia care unit (PACU), the patient will be transferred to the ICU as a case of postoperative care after elective spinal diskectomy surgeries (cervical, dorsal or lumber) with removal of the damaged portion of the herniated or degenerated disks. Admission to ICU will be for medical, surgical or anesthesia related causes. * Standard monitoring devices via GE monitor will be connected to the patient as electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SPO2 as a percentage) and non-invasive blood pressure (NIBP) (mmHg).Temperature of the patient in Celsius (◦C), random blood sugar (mg/dl) and urine output (ml/hour) will be monitored also. Follow-up by standard postoperative laboratory tests will be done too. * After the patient will regain feeding according to the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines \[1\],the consented and enrolled 120 patients will be randomly assigned to one of the following groups and oral drug will be taken with sips of water: * Group G (40 patients): Gabapentin (GaptinR) 400mg oral capsule * Group T (40 patients): Trospium chloride slow release (TrospikanR SR) 60mg oral capsule * Group C (40 patients): Non-pharmacological standard of care control group who administered nothing * Incidence and severity of CRBD will be assessed by 4-point severity scale developed by Agarwal in1,2,6,12,24 hours after the study drugs intake . Assessment of pain severity and control will be done by using Numerical Pain Rating Scale (NPRS) and measuring total fentanyl requirements in the 1st 24h in micrograms (µg/day). Side effects of the study drugs will be recorded and managed accordingly with the use of Ramsay sedation score to assess sedation level one hour after the study drugs intake . * Patients will continue their monitored care in the ICU till the control of the causes of their ICU admission or their end. * Demographic data, causes for postoperative care in the ICU (Medical, surgical or anesthesia related) and spine surgery site and number for each (cervical, dorsal, lumber) will be collected and recorded.The collected study data results will be revised, electronically recorded in datasheet, coded, tabulated, analyzed, and processed using the proper computerized statistical package program. Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between groups to identify any significant differences between them

Conditions

• Catheter-related Bladder Discomfort (CRBD)

Interventions

Type	Name	Description
DRUG	Gabapentin (Gaptin ®) 400mg oral capsule once	After the patient will regain feeding, the patients will take with sips of water Gabapentin (Gaptin ®) 400mg oral capsule once in the first 24 hour after icu admission
DRUG	Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule	After the patient will regain feeding, the patients will take with sips of water Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule once in the first 24 hour after icu admission

Timeline

• Start date: 2024-04-10
• Primary completion: 2024-09-01
• Completion: 2024-09-20
• First posted: 2024-04-04
• Last updated: 2025-07-28

Locations

1 site across 1 country: Egypt