Post Operative Urinary Retention, Spinal Aneshtesia
Conditions
Keywords
POUR, Spinal Anesthesia, Dexamethasone, Intravenous Corticosteriods, Urinary Complications, Perioperative Complications, Placebo-Controlled Trial, Randomized Controlled Trial, Al-Makassed Hospital, Postoperative Urinary Retention
Brief summary
What is this study about? This study is testing whether a common medication called dexamethasone, given through a vein (IV) before surgery, can help prevent a problem called postoperative urinary retention (POUR). POUR means having trouble urinating after surgery, which can cause discomfort and sometimes requires using a catheter. Who can join the study? The study includes adult People who are having surgery with spinal anesthesia at Al-Makassed Hospital. People who have certain medical conditions, use steroids regularly, or need a catheter during surgery cannot join. What will happen in the study? Participants will be randomly assigned to one of two groups: * One group will get 8 mg of IV dexamethasone before surgery. * The other group will get a saltwater (placebo) injection. Neither the participants nor the doctors will know which treatment they receive. After surgery, the researchers will check how soon each participant can urinate and whether they need a catheter. Why is this study important? POUR can slow recovery and cause complications. Dexamethasone is already used for other reasons like nausea and swelling. This study will help find out if it also lowers the risk of POUR in people getting spinal anesthesia.
Detailed description
Postoperative urinary retention (POUR) is a common complication following spinal anesthesia, affecting patient comfort, recovery, and sometimes requiring catheterization. While dexamethasone is routinely used to prevent nausea and inflammation in surgical patients, its potential role in preventing POUR has not been fully explored, especially in the context of spinal anesthesia. This study is a prospective, randomized, double-blind, placebo-controlled clinical trial conducted at Al-Makassed Hospital. It aims to evaluate whether a single preoperative intravenous dose of 8 mg dexamethasone reduces the incidence of POUR in adult patients undergoing elective surgery under spinal anesthesia. Eligible participants are randomized into two equal groups using block randomization. One group receives 8 mg of IV dexamethasone, and the other receives a placebo (0.9% saline). Both patients and assessors are blinded to group assignment. Data will be collected on age, BMI, comorbidities (including history of BPH or prior POUR), current anticholinergic drug use, anesthetic agent and dose, which level of spinal anesthesia (e.g. L3-L4), type of surgery, IV fluid volume, and duration of operation. The primary outcome is the incidence of POUR, defined as failure to void within 6 hours after surgery and requiring catheterization. Secondary outcomes include time to first void and the overall need for urinary catheterization. Safety data will also be recorded, and any adverse events related to dexamethasone will be reported. The study has been approved by the Al-Quds University Research Ethics Committee. All participants will provide informed consent prior to enrollment.
Interventions
Intravenous administration of 8 mg dexamethasone sodium phosphate given as a single dose before surgery under spinal anesthesia. This corticosteroid is being evaluated for its potential to prevent postoperative urinary retention (POUR) by reducing inflammation and other perioperative effects.
DRUGNormal Saline (0.9% NaCl)
Intravenous administration of 0.9% normal saline (placebo) given as a single dose before surgery under spinal anesthesia. This inert solution is used to compare against the active drug dexamethasone to determine its effect on postoperative urinary retention (POUR).
Sponsors
Al-Quds University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blinded study. Both participants and outcome assessors are unaware of the group assignments. A non-participating physician performed the randomization using a computer-generated block randomization list. Study drugs (dexamethasone or placebo) are prepared in identical syringes labeled with participant codes only, ensuring that care providers and investigators remain blinded during the intervention and follow-up period.
Intervention model description
Participants are randomly assigned in a 1:1 ratio to receive either a single 8 mg dose of intravenous dexamethasone or a placebo (0.9% normal saline) prior to surgery under spinal anesthesia. Each participant remains in their assigned group throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients at Al-Makassed Hospital undergoing spinal anesthesia for surgery
Exclusion criteria
* Chronic steroid use * Individuals who should not be administered dexamethasone * Have a history of urological issues or procedures * Have neurological disorders * Using an intraoperative Foley's catheter * Operations for possible nerve damage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Urinary Retention (POUR) | Measured within 6 hours postoperatively. | The percentage of participants who fail to void within 6 hours after surgery and require urinary catheterization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Urination | Recorded within the first 24 hours after surgery. | Time elapsed from the end of surgery until the participant first voids spontaneously. |
| Need for Urinary Catheterization | During hospital stay post-surgery (up to 24 hours) | Number and percentage of participants who require catheterization at any time during postoperative monitoring. |
| Adverse Events Related to Dexamethasone | From drug administration to 24 hours postoperative. | Incidence and type of adverse events possibly related to dexamethasone administration (e.g., allergic reactions). |
Countries
Palestinian Territories
Contacts
PRINCIPAL_INVESTIGATORAbeer J Dar Hasan, MD
Al-Makassed Islamic Charitable Society Hospital and Al-Quds University
STUDY_DIRECTORMohammed M Maree, MD
Al-Makassed Islamic Charitable Society Hospital and Al-Quds University
Outcome results
None listed