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NCT Number: NCT07077850

Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Post Operative Urinary Retention Spinal Aneshtesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Makassed Islamic Charitable Society Hospital

East Jerusalem, Al-Makassed Islamic Charitable Society Hospital, 9710000, Palestinian Territories

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone (IV)

Drug

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.

Other names: Dexamethasone Sodium Phosphate

Normal Saline (0.9% NaCl)

Drug

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).

Other names: Isotonic Saline

Primary outcomes

  1. Incidence of Postoperative Urinary Retention (POUR)

    Time frame: Measured within 6 hours postoperatively.

    The percentage of participants who fail to void within 6 hours after surgery and require urinary catheterization.

Secondary outcomes

  1. Time to First Urination

    Time frame: Recorded within the first 24 hours after surgery.

    Time elapsed from the end of surgery until the participant first voids spontaneously.

  2. Need for Urinary Catheterization

    Time frame: During hospital stay post-surgery (up to 24 hours)

    Number and percentage of participants who require catheterization at any time during postoperative monitoring.

  3. Adverse Events Related to Dexamethasone

    Time frame: From drug administration to 24 hours postoperative.

    Incidence and type of adverse events possibly related to dexamethasone administration (e.g., allergic reactions).

Sponsors and collaborators

Lead sponsor

Al-Quds University

Other

Registry information

Official study title

The Effectiveness of Intravenous Dexamethasone Prophylaxis in Preventing Post-operative Urinary Retention in Spinal Anesthesia at Al-Makassed Hospital

Acronym: DEX-PUR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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