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

NCT07077850 | Active Not Recruiting

• 1 other identifier: DEX-PUR Trial
• Study Type: interventional
• Target: 1,084
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Urinary Retention; Spinal Aneshtesia

Keywords

POUR; Spinal Anesthesia; Dexamethasone; Intravenous Corticosteriods; Urinary Complications; Perioperative Complications; Placebo-Controlled Trial; Randomized Controlled Trial; Al-Makassed Hospital; Postoperative Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Urinary Retention (POUR)

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

  Measured within 6 hours postoperatively.

Secondary Outcomes (3)

• Time to First Urination

  Recorded within the first 24 hours after surgery.

• Need for Urinary Catheterization

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

• Adverse Events Related to Dexamethasone

  From drug administration to 24 hours postoperative.

Study Arms (2)

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

PLACEBO COMPARATOR

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).

Drug: Normal Saline (0.9% NaCl)

Arm 1: Dexamethasone group

EXPERIMENTAL

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).

Drug: Dexamethasone (IV)

Interventions

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.

Also known as: Dexamethasone Sodium Phosphate

Arm 1: Dexamethasone group

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).

Also known as: Isotonic Saline

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients at Al-Makassed Hospital undergoing spinal anesthesia for surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Quds University: lead

Study Sites (1)

Al-Makassed Islamic Charitable Society Hospital

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

Location

Related Publications (7)

• Neff SP, Stapelberg F, Warmington A. Excruciating perineal pain after intravenous dexamethasone. Anaesth Intensive Care. 2002 Jun;30(3):370-1. doi: 10.1177/0310057X0203000319.

  PMID: 12075649 BACKGROUND

• Toftegaard M, Knudsen F. Massive vasopressin-resistant polyuria induced by dexamethasone. Intensive Care Med. 1995 Mar;21(3):238-40. doi: 10.1007/BF01701480.

  PMID: 7790612 BACKGROUND

• Primack A, Kajubi S. Insulin and growth hormone response to an oral glucose load in Ugandan hepatocellular carcinoma patients. East Afr Med J. 1974 Aug;51(8):574-8. No abstract available.

  PMID: 4371198 BACKGROUND

• Denham M, Donovan K, Wetoska N, Kuchta K, Carbray J, Linn JG, Denham W, Haggerty SP, Joehl R, Ujiki M. Effects of dexamethasone on postoperative urinary retention after laparoscopic inguinal hernia repair. Surg Endosc. 2019 Sep;33(9):3008-3013. doi: 10.1007/s00464-018-6572-7. Epub 2018 Nov 7.

  PMID: 30406386 BACKGROUND

• Splinter WM, Roberts DJ. Dexamethasone decreases vomiting by children after tonsillectomy. Anesth Analg. 1996 Nov;83(5):913-6. doi: 10.1097/00000539-199611000-00004.

  PMID: 8895262 BACKGROUND

• Levin RM, Longhurst PA, Monson FC, Kato K, Wein AJ. Effect of bladder outlet obstruction on the morphology, physiology, and pharmacology of the bladder. Prostate Suppl. 1990;3:9-26. doi: 10.1002/pros.2990170503.

  PMID: 1689174 BACKGROUND

• Kamphuis ET, Ionescu TI, Kuipers PW, de Gier J, van Venrooij GE, Boon TA. Recovery of storage and emptying functions of the urinary bladder after spinal anesthesia with lidocaine and with bupivacaine in men. Anesthesiology. 1998 Feb;88(2):310-6. doi: 10.1097/00000542-199802000-00007.

  PMID: 9477049 BACKGROUND

MeSH Terms

Interventions

Dexamethasone; dexamethasone 21-phosphate; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Abeer J Dar Hasan, MD

  Al-Makassed Islamic Charitable Society Hospital and Al-Quds University

  PRINCIPAL INVESTIGATOR

• Mohammed M Maree, MD

  Al-Makassed Islamic Charitable Society Hospital and Al-Quds University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abeer Jafar Dar Hasan , General Surgery Senior Resident, MBBS

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 22, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)