Comparison of the effect of gabapentin and oral pregabalin on spinal anesthesia

Comparison the effect of preoperative use of oral gabapentin and pregabalin on spinal anesthesia characteristics and side effects

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200918048748N1

Enrollment

Registered

2020-11-02

Start date

2019-06-24

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Spinal anesthesia. Spinal and epidural anesthesia-induced headache during the puerperium

Interventions

Intervention 1: Intervention group: Group A with 300 mg of oral gabapentin made in Iran and Abidi Pharmaceutical Company, Patients receive this substance 2 hours before surgery. In sterile conditions

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Being at the age of 18-70 years ASA class 1-2 undergoing orthopedic elective surgery with spinal anesthesia below the T10 level Duration of surgery less than 2 hours

Exclusion criteria

Exclusion criteria: Weight less than 40 kg Hypersensitivity to pregabalin Hypersensitivity to the drug gabapentin Allergy to bupivacaine Localized sepsis at the injection site of the spinal needle Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Postoperative nausea and vomiting. Timepoint: They are measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: The incidence and severity of postoperative nausea and vomiting are assessed based on the simplified criterion of postoperative nausea and vomiting (PONV scale).;Sensory block start time. Timepoint: It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: Based on the Visual Analogue Scale and recorded in the checklist.;Duration of anesthesia. Timepoint: It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: Based on the Visual Analogue Scale and recorded in the checklist.	—

Measure

Time frame

Postoperative nausea and vomiting. Timepoint: They are measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: The incidence and severity of postoperative nausea and vomiting are assessed based on the simplified criterion of postoperative nausea and vomiting (PONV scale).;Sensory block start time. Timepoint: It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: Based on the Visual Analogue Scale and recorded in the checklist.;Duration of anesthesia. Timepoint: It is measured and recorded every 5 minutes until the end of the operation and every 15 minutes in recovery for up to two hours. Method of measurement: Based on the Visual Analogue Scale and recorded in the checklist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNiloofar Barzegar

Kashan University of Medical Sciences

n.barzegar87@gmail.com+98 31 5550 0111

Outcome results

None listed

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