Investigating the effect of intraspinal narcotic injection on the occurrence of pruritus in patients with opium abuse disorder undergoing orthopedic surgery

Evaluation the effect of intrathecal injection on the incidence and severity of pruritus in opium use disorder patients undergoing lower limbs orthopedic surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231223060498N1

Enrollment

Registered

2024-02-07

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-03-06

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

Conditions

Condition 1: Patients for elective lower limb fracture surgery(Superficial injury of knee and lower leg). Condition 2: Patients for elective lower limb fracture surgery(Injuries to the ankle and foot). Superficial injury of knee and lower leg Injuries to the ankle and foot

Interventions

Intervention 1: Intervention group: A group of addicts who will receive intrathecal Marcaine with fentanyl for spinal anesthesia. Intervention 2: Intervention group: A group of addicts who will receiv

Eligibility

Sex/Gender

All

Age

20 Years to 55 Years

Inclusion criteria

Inclusion criteria: People addicted to opium, 20-55 years old Anesthesia status in class I and II classification of the American Society of Anesthesiology (ASA) Sign the informed consent form Drug users who are only addicted to opium

Exclusion criteria

Exclusion criteria: Presence of neurological disorders Coagulation problem Presence of local skin infection at the injection site High pressure of cerebrospinal fluid Presence of sensitivity to local anesthetics Cortone use in the last year Taking antihistamine in the last 8 weeks History of food and drug allergy People who use other drugs besides opium

Design outcomes

Primary

Measure	Time frame
Prevalence and intensity itching. Timepoint: prevalence and intensity itching during surgery and recovery. Method of measurement: The severity of itching will be determined based on the extent of the itching area. In this way, itching in one area of the body will be considered mild, itching in two different areas of the body as moderate, and itching in 3 or more separate areas (generalized itching) will consider as severe.?.	—

Measure

Time frame

Prevalence and intensity itching. Timepoint: prevalence and intensity itching during surgery and recovery. Method of measurement: The severity of itching will be determined based on the extent of the itching area. In this way, itching in one area of the body will be considered mild, itching in two different areas of the body as moderate, and itching in 3 or more separate areas (generalized itching) will consider as severe.?.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mansour Deylami

Gorgan University of Medical Sciences

Mansour.deylami@gmail.com+98 17 3115 3311

Outcome results

None listed

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