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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Catheter-related Bladder Discomfort (CRBD)

Treatments: Drug: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule; Drug: Gabapentin (Gaptin ®) 400mg oral capsule once

Study type: Interventional

Funder types: Other

Identifiers

NCT06346522

FMASU R37/2024

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Both males and females with age 20-65 years
• American Society of Anesthesiologists (ASA) physical status class I, II or III.
• Patients will undergoing elective spinal surgery and will require catheterization of the urinary bladder.

Exclusion criteria

• known allergy to the study drugs or patient refusal.
• Urinary bladder pathology as overactive bladder (frequency more than 3 times in the night or more than 8 times in 24 h), bladder outflow obstruction, urinary tract infection or malignancy
• Preoperative neurological bladder and/or bowel involvement secondary to spinal cord compression.
• Chronic opioids use for chronic pain, drugs or alcohol abuse
• Moderate to severe hepatic disease, renal impairment with creatinine clearance (CrCl) less than 30 ml/minute
• Narrow angle glaucoma
• Psychiatric diseases
• Gastrointestinal obstructive conditions as severe chronic constipation or ileus

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

-Group G (40 patients): Gabapentin

Active Comparator group

Description:

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

Treatment:

Drug: Gabapentin (Gaptin ®) 400mg oral capsule once

-Group T (40 patients): Trospium chloride slow release

Active Comparator group

Description:

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

Treatment:

Drug: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule

Group C (40 patients): Non-pharmacological standard of care control group

No Intervention group

Description:

Non-pharmacological standard of care control group who administered nothing