Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia
NCT ID: NCT07077850
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1084 participants
INTERVENTIONAL
2025-08-20
2026-08-20
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm 2: Placebo Group (Participants receiving intravenous 0.9% saline as placebo)
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).
Normal 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).
Arm 1: Dexamethasone group
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).
Dexamethasone (IV)
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.
Interventions
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Dexamethasone (IV)
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.
Normal 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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Al-Quds University
OTHER
Responsible Party
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Abeer Hasan
Abeer Jafar Dar Hasan , General Surgery Senior Resident, MBBS
Principal Investigators
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Abeer J Dar Hasan, MD
Role: PRINCIPAL_INVESTIGATOR
Al-Makassed Islamic Charitable Society Hospital and Al-Quds University
Mohammed M Maree, MD
Role: STUDY_DIRECTOR
Al-Makassed Islamic Charitable Society Hospital and Al-Quds University
Locations
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Al-Makassed Islamic Charitable Society Hospital
East Jerusalem, Al-Makassed Islamic Charitable Society Hospital, Palestinian Territories
Countries
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References
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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.
Toftegaard M, Knudsen F. Massive vasopressin-resistant polyuria induced by dexamethasone. Intensive Care Med. 1995 Mar;21(3):238-40. doi: 10.1007/BF01701480.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Proposal
Document Type: Study Protocol and Statistical Analysis Plan: application form
Document Type: Study Protocol and Statistical Analysis Plan: check list
Document Type: Study Protocol and Statistical Analysis Plan: REC approval
Other Identifiers
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DEX-PUR Trial
Identifier Type: -
Identifier Source: org_study_id
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