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Comparison of two method of spinal anesthesia in opium addicts

Evaluation of the effects of adding Fentanyl to Bupivacaine in spinal anesthesia in opium addicted patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012092210900N1
Enrollment
60
Registered
2013-09-22
Start date
2012-08-01
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

Opium Addiction. Mental and behavioural disorders due to use of opioids

Interventions

Intervention 1: Patients in control group undergo spinal anesthesia with 12.5 mg Bupivacaine (20mg/4ml, manufactured by ICI Pharmaceuticals India Limited) plus 0.5 ml sterile instilled water. Interven
Treatment - Drugs
Patients in control group undergo spinal anesthesia with 12.5 mg Bupivacaine (20mg/4ml, manufactured by ICI Pharmaceuticals India Limited) plus 0.5 ml sterile instilled water
In intervention group spinal anesthesia is performed using 12.5 mg bupivacaine (20mg/4ml, made by ICI Pharmaceuticals India Limited) and 25µg fentanyl (0.5mg/10ml, manufactured by Aburaihan Co.Iran).

Sponsors

Deputy of Research Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) patient's consent of spinal anesthesia. 2) The patient who are admitted for lower abdomen and lower extremity surgery. 3) patients who are in the age range of 65-15 year 4) Patients in the height range between 185 - 150 cm 5)opium addict is a person who have used opium orally or inhales it at least for one year 6) surgery length of 80 to 150 minutes 7) No history of other drug abuse and psychological disorders. 8) Weight between 50 to 85 kg. exclusion criteria: 1- consuming other kinds of drugs 2- history of pulmonary or cardiac diseases 3-history of disorders which have absolute or partial contraindication for spinal anesthesia 4- history of hypersensitivity to fentanyl or bupivacaine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
The onset of pain after surgery. Timepoint: after operation. Method of measurement: asking the patient.

Secondary

MeasureTime frame
Blood pressure. Timepoint: every 5 minutes and every 15 minutes in PACU. Method of measurement: digital monitoring device.;The length of sensory nerves block. Timepoint: at 40,50,60,70,80,90,100,110 and 120 minutes. Method of measurement: skin stimulation test.;The length of motor nerves block. Timepoint: at 40,50,60,70,80,90,100,110 and 120 minutes. Method of measurement: asking the patient to move his legs.;The time of onset the analgesia. Timepoint: after performing the procedure. Method of measurement: skin stimulation test.;Nausea and vomiting. Timepoint: throughout the operation and in PACU. Method of measurement: asking the patient.;Itching. Timepoint: throughout the operation and in PACU. Method of measurement: asking the patient.;Shivering. Timepoint: throughout the operation and in PACU. Method of measurement: observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzam Karimi

Kerman University of Medical Sciences

javakrd34@gmail.com+98 34 1322 2250

Outcome results

None listed

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