Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia
- Conditions
- Post Operative Urinary RetentionSpinal Aneshtesia
- Interventions
- Drug: Normal Saline (0.9% NaCl)
- Registration Number
- NCT07077850
- Lead Sponsor
- Al-Quds University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1084
- Adult patients at Al-Makassed Hospital undergoing spinal anesthesia for surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: Placebo Group (Participants receiving intravenous 0.9% saline as placebo) Normal Saline (0.9% NaCl) Participants in this arm will receive an intravenous injection of 0.9% normal saline (placebo) before undergoing surgery under spinal anesthesia. This group is used to compare the effect of dexamethasone on the incidence of postoperative urinary retention (POUR). Arm 1: Dexamethasone group Dexamethasone (IV) Participants in this arm will receive a single 8 mg dose of intravenous dexamethasone before undergoing surgery under spinal anesthesia. The intervention is administered preoperatively to evaluate its effectiveness in reducing the risk of postoperative urinary retention (POUR).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Al-Makassed Islamic Charitable Society Hospital
🇵🇸E. Jerusalem, Al-Makassed Islamic Charitable Society Hospital, Palestinian Territory, occupied
Al-Makassed Islamic Charitable Society Hospital🇵🇸E. Jerusalem, Al-Makassed Islamic Charitable Society Hospital, Palestinian Territory, occupied