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

NCT ID: NCT06346522

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2024-09-20

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

-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

Group Type: ACTIVE_COMPARATOR

Gabapentin (Gaptin ®) 400mg oral capsule once

Intervention Type: DRUG

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

-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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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

Non-pharmacological standard of care control group who administered nothing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Gaptin ®; Trospikan ® SR

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed M Mohamed, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shames University

Locations

Ain Shams University-Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 34242915 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16415311 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4835444 (View on PubMed)

Other Identifiers

FMASU R37/2024

Identifier Type: -

Identifier Source: org_study_id