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Effect of a new drug ( Methyl-Naltrexone) in reducing urinary complication after use of Morphine

Evaluation of the effect of Methyl-Naltrexone in reducing urinary retention after orthopedic surgeries under spinal anesthesia by Bupivacaine and Morphine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204145172N3
Enrollment
70
Registered
2012-07-07
Start date
2012-07-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention. Disorder of urinary system, unspecified

Interventions

Intervention 1: As usual anesthetic protocol,10 mg intrathecal bupivacaine 0.5% and 0.1 are injected
immediately, 12mg methyl Naltrexone subcutaneously (by a trained nurse who is unaware of any drugs) will be administered to patients in the first group. Then during surgery and 24 hours after it, sy
immediately, placebo subcutaneously (by a trained nurse who is unaware of any drugs) will be administered to patients in the second group. Then during surgery and 24 hours after it, symptoms such as u
Prevention
As usual anesthetic protocol,10 mg intrathecal bupivacaine 0.5% and 0.1 are injected
immediately, 12mg methyl Naltrexone subcutaneously (by a trained nurse who is unaware of any drugs) will be administered to patients in the first group. Then during surgery and 24 hours after it, s
As usual anesthetic protocol,10 mg intrathecal bupivacaine 0.5% and 0.1 are injected

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:18 – 50 years old patient ; planned orthopedic surgery on lower Extremities; usual criteria for spinal anesthesia Exclusion Criteria : Peri-op Int. folley; Genito-urinary problems (Benign prostatic hyperplasia, Urinary stone, Renal failure, … ); Addiction (in 6 mounts before operation) ; Use of opioids in 12 hours before operation; Neurologic Disease (stroke, alcohol/diabete neuropathies, cerebral palsy, spinal lesions, multiple sclerosis, poly myositis ) ; Drugs ( anti-cholinergics, ß-blockers, Sympathomimetics, a-agonists/antagonists)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Urinary retention. Timepoint: every 1 hour till 24 hours after surgery. Method of measurement: By a questionnaire of urinary retention: a) the patient's inability to pass urine after surgery, despite feeling a need to urinating for half an hour and leaving every amount of urine after catheterization. B) inability to pass urine for 12 hours after surgery, without feeling a need to urinating and leaving at least 600 cc of urine after catheterization.

Secondary

MeasureTime frame
Itching. Timepoint: every 1 hour till 24 hours after surgery. Method of measurement: By a questionnaire of itching: incidence of itching to the extent that the patient seek treatment.;Nausea, vomiting. Timepoint: every 1 hour till 24 hours after surgery. Method of measurement: By a questionnaire of nausea and vomiting: a) the incidence of nausea in the interval 4 to 24 hours after surgery (each of which is questioned by a trained nurse), b)vomit the stomach contents in 4 to 24 hours after surgery.;Respiratory suppression. Timepoint: every 1 hour till 24 hours after surgery. Method of measurement: By a questionnaire of suppressed breathing, reduced respiratory rate less than 8 per minutes for 24 hours after surgery (each hour can be recorded by trained nurses).;Decreased level of consciousness. Timepoint: every 1 hour till 24 hours after surgery. Method of measurement: By a questionnaire of decreased level of consciousness: drowsiness or dizziness that each hour until 24 hours after surgery are recorded by trained nurses.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaman Asadi, MD

Shiraz University of Medical Sciences

asadisa@sums.ac.ir+98 71 1231 8072

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026