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Study of the preventive effect of Pregabalin administration on pruritus caused by Intrathecal Fentanyl

Study of the preventive effect of Pregabalin administration on pruritus caused by Intrathecal Fentanyl in patients undergoing elective leg orthopedic surgery under spinal anesthesia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251001067462N1
Enrollment
80
Registered
2025-11-06
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

pruritus of intrathecal Fentanyl in spinal anesthesia.

Interventions

Intervention 1: Intervention group: Patients receiving one capsule pregabalin 100MG PO under the trade name LYRICER ,from Actoverco Pharmaceutical Company with a small amount of water one hour Abefore

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-65 years who are candidates for elective lower leg surgery under Spinal anesthesia Individuals with an American Society of Physical Therapists (ASA) grade I or II condition no history of pregabalin or fentanyl allergy no use of gabapentinoids in the last week

Exclusion criteria

Exclusion criteria: Contraindications for spinal anesthesia Refusal to continue studying Need to convert spinal anesthesia to general anesthesia Any complaints of skin itching before surgery Known history of hypersensitivity to pregabalin or severe adverse reactions to pregabalin (such as skin rash or angioedema) Current skin disease Any systemic disease accompanied by itching Patients receiving glucocorticoids

Design outcomes

Primary

MeasureTime frame
Itching severity. Timepoint: 1 , 2 , 6 , 12 , 24 hour after Spinal anesthesia. Method of measurement: Visual Analogue Scale.;Time of itching outbreak. Timepoint: 1 , 2 , 6 , 12 , 24 hour after Spinal anesthesia. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
Weight. Timepoint: Before the intervention begins. Method of measurement: Kilogrammes.;Need for adjuvant treatment. Timepoint: 1,2,6,12,24 hour after Spinal anesthesia. Method of measurement: Need or not need.;Patient satisfaction with itching control. Timepoint: 1,2,6,12,24 hour after Spinal anesthesia. Method of measurement: Based on a Visual Analogue Scale from 0 to 10.;Side effects of medication. Timepoint: Up to 24 hours after the intervention. Method of measurement: Existence or non-existence.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mehrdad Malekshoar

Bandare-abbas University of Medical Sciences

info@hums.ac.ir+98 76 3333 3280

Outcome results

None listed

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