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

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.

Study Overview

• Status: Completed
• Conditions: Catheter-related Bladder Discomfort (CRBD)
• Intervention / Treatment: Drug: Gabapentin (Gaptin ®) 400mg oral capsule once; Drug: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University-Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: -Group G (40 patients): Gabapentin; 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: 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; Other Names: Gaptin ®
Active Comparator: -Group T (40 patients): Trospium chloride slow release; 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	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; Other Names: Trospikan ® SR
No Intervention: Group C (40 patients): Non-pharmacological standard of care control group; Non-pharmacological standard of care control group who administered nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake	Severity of CRBD will be assessed and recorded by a CRBD 4-point severity scale developed by Agarwal et al as following: No discomfort; Mild: urinary urgency or suprapubic discomfort reported by the patient on questioning only; Moderate: urinary urgency or suprapubic discomfort reported by the patient themselves without being questioned and not accompanied by behavioral changes; Severe: urinary urgency or suprapubic discomfort reported by the patient themselves and accompanied by behavioral changes such as attempts to remove the catheter, verbal responses, and restless movements of extremities) [2]	First 24 hours after the study drugs intake

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fentanyl requirements in micrograms (µg)	Total fentanyl requirements in the 1st 24h after study drugs intake in micrograms (µg/day)	First 24 hours after the study drugs intake
Numerical Pain Rating Scale (NPRS) (0-10)	NPRS for measurement of surgical pain intensity. It consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').NPRS will be assessed at 1,2,6,12,24 hours after the study drugs intake.	First 24 hours after the study drugs intake
Side effects of the study drugs	They includes: Nausea and vomiting; Dry mouth; Light headedness or confusion; Headache; Tachycardia; Blurred vision; Facial flushing; Agitation; Constipation	First 24 hours after the study drugs intake
Ramsay sedation score	Ramsay sedation score [3].It will be assessed after one hour of the study drugs intake Score Sedation level; Awake; agitated or restless or both; Awake; cooperative, oriented, and tranquil; Awake but responds to commands only; Asleep; brisk response to light glabellar tap or loud auditory stimulus; Asleep; sluggish response to light glabellar tap or loud auditory stimulus; Asleep; no response to glabellar tap or loud auditory stimulus	After one hour of the study drugs intake

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ahmed M Mohamed, MD, Ain Shames University

Publications and helpful links

General Publications

• Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
• Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative care; Gabapentin; Intensive Care Unit (ICU); Trospium chloride; Catheter-related bladder discomfort (CRBD)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antimanic Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Urological Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Gabapentin; Trospium chloride
• Other Study ID Numbers: FMASU R37/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The datasets used and analyzed during the current study are available from the corresponding author on reasonable request, with hiding of identities of participants or any personal information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No