Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia (DEX-PUR)

Al-Quds University

Status: Active, not recruiting

Conditions: Spinal Aneshtesia; Post Operative Urinary Retention

Treatments: Drug: Dexamethasone (IV); Drug: Normal Saline (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT07077850

DEX-PUR Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,084 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,084 participants in 2 patient groups, including a placebo group

Arm 2: Placebo Group (Participants receiving intravenous 0.9% saline as placebo)

Placebo Comparator group

Description:

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).

Treatment:

Drug: Normal Saline (0.9% NaCl)

Arm 1: Dexamethasone group

Experimental group

Description:

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).

Treatment:

Drug: Dexamethasone (IV)