A Phase 4 interventional study of Acetazolamide and Standard Care (in control arm) in Cerebrospinal Fluid Leak, Dural Tear and Incidental Durotomy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
This study aims to evaluate the effectiveness and safety of acetazolamide in helping patients recover from accidental dural tears during spine surgery. Adding acetazolamide to standard post-surgery care is hypothesized to be a safe and effective way to reduce spinal fluid leakage, ease headaches, and speed up recovery.
Researchers conducted a randomized controlled trial with 26 patients who experienced a dural tear during spine surgery at Ain Shams University Hospitals. The patients were divided into two equal groups of 13: The Interventional Group received 250 mg of acetazolamide three times daily for 2 weeks alongside standard care, while the Control Group received standard care without acetazolamide. The team measured the amount of spinal fluid draining from patients, how long it took for wounds to close, headache severity, and any side effects over the postoperative period.
46 studies on the registry are indexed under Cerebrospinal Fluid Leak; 10 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 29 interventional studies indexed under Cerebrospinal Fluid Leak.
Browse Cerebrospinal Fluid Leak studies →Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Received 250 mg of acetazolamide three times daily for 2 weeks alongside standard care.
Drug: Acetazolamide
Received standard care without acetazolamide
Other: Standard Care (in control arm)
250 mg three times daily for 2 weeks
Standard postoperative care without acetazolamide
Lumbar Drain Output
Daily volume of cerebrospinal fluid (CSF) drainage measured in milliliters (mL) collected via the non-suction lumbar drain.
Time frame: Daily on postoperative days 1, 2, 3, and 4
Time to Complete Wound Closure
Number of days from surgery until complete wound epithelialization and cessation of any fluid leakage.
Time frame: Up to 20 days postoperatively
Orthostatic Headache Score
Severity of positional headache calculated as the difference between recumbent and standing positions using the Visual Analogue Scale (VAS, range 0-100 mm; higher scores indicate greater pain severity).
Time frame: Postoperative day 3
Incidence of Postoperative Complications
Number of participants experiencing adverse events including pseudo meningocele formation, postoperative meningitis, or drug-related hypokalemia.
Time frame: Postoperative day 14 (end of treatment period)
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetazolamide