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IRCT201204145172N3 IRCT 2012-07-07 Shiraz University of Medical Sciences 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 2012-07-22 anticipated 70 Complete https://irct.ir/trial/5533 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A Urinary Retention. 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, symptoms such as urinary retention, nausea and vomiting, itching, respiratory suppression and decreased level of consciousness are investigated. Intervention 2: As usual anesthetic protocol,10 mg intrathecal bupivacaine 0.5% and 0.1 are injected; 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 urinary retention, nausea and vomiting, itching, respiratory suppression and decreased level of consciousness are investigated.

public Saman Asadi, MD

Anestheiology office, Shahid Faghihi Hospital, Shiraz

Shiraz Iran (Islamic Republic of) +98 71 1231 8072 asadisa@sums.ac.ir Shiraz University of Medical Sciences scientific Farid Zand, MD

Anesthesiology office, Shahid Faghihi Hospital, Shiraz

Shiraz Iran (Islamic Republic of) +98 71 1231 8072 zandf@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 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, β-blockers, Sympathomimetics, α-agonists/antagonists) 18 years 50 years Both N39.9 Disorder of urinary system, unspecified Prevention 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, symptoms such as urinary retention, nausea and vomiting, itching, respiratory suppression and decreased level of consciousness are investigated As usual anesthetic protocol,10 mg intrathecal bupivacaine 0.5% and 0.1 are injected; 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 urinary retention, nausea and vomiting, itching, respiratory suppression and decreased level of consciousness are investigated 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. 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. Shiraz University of Medical Sciences Approved 2012-01-21 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences Shiraz Iran (Islamic Republic of)