Comparing the effect of adding morphine or pethidine to bupivacaine into the spinal space while producing numbness for cesarean section surgery on post-operative pain of pregnant women with a pregnancy age of over 37 weeks

Comparing the effect of adding intrathecal morphine or pethidine to bupivacaine in spinal anesthesia during cesarean section surgery on post-operative pain of pregnant women with a gestational age of over 37 weeks

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140615018091N10

Enrollment

110

Registered

2020-04-15

Start date

2017-06-05

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Condition 1: pregnancy. Condition 2: spinal anesthesia. Condition 3: hemodynamic changes. Condition 4: postoperative pain. Other acute postprocedural pain

Interventions

Intervention 1: The first intervention group parturients while being in the sitting position, a Quincke needle No. 25 will be inserted into the lumbar space 3-4 or 4-5 and a total volume of 3 ml of a

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age 18-50 Gestational age of over 37 weeks American Society of Anesthesiologists physical status classes I and II Candidate for a cesarean section surgery

Exclusion criteria

Exclusion criteria: Emergency cesarean section Limitations for applying regional block, Valvular heart disease A history of allergy to the target drugs Addicts Alcoholics Preeclampsia Diabetes Unwillingness to take part in the research

Design outcomes

Primary

Measure	Time frame
Severity of post surgical pain. Timepoint: 1st, 4th and 24th hours after surgery. Method of measurement: Numeric Rating Scale.;The first demand for analgesia. Timepoint: after the surgery. Method of measurement: minutes after the surgery.;Dose of the analgesic. Timepoint: after the surgery. Method of measurement: the number of diclofenac suppositories (100 mg) applied.	—

Secondary

Measure	Time frame
Nausea and vomiting. Timepoint: 1st, 4th and 24th hours after surgery. Method of measurement: Quantitative frequency will be recorded on questionnaire.;Itching. Timepoint: During surgery and in the 1st, 4th and 24th after the surgery. Method of measurement: Quantitative frequency will be recorded on questionnaire.;Blood pressure (systolic and diastolic). Timepoint: The first 10 minutes will be measured every 3 minutes and then every 5 minutes till the end of the surgery. Post-operatively at the 1st, 4th and 24th hours. Method of measurement: Non-invasive blood pressure device.;Respiratory rate. Timepoint: Within the first 10 minutes every 3 minutes and then every 5 minutes till the end of the surgery. Post-operatively at the 1st, 4th and 24th hours. Method of measurement: Respiration monitoring by using Electrocardiograph device.;Sedation condition. Timepoint: During the surgery as well as in the 1st, 4th and 24th hours after surgery. Method of measurement: Ramsey Sedation Scale.;Assessment for infants health condition after delivery. Timepoint: 1st and 5th minutes of birth. Method of measurement: Apgar score.;Shivering. Timepoint: During the surgery and in the 1st, hours after surgery. Method of measurement: Quantitative frequency recorded on questionnaire.	—

Measure

Time frame

Nausea and vomiting. Timepoint: 1st, 4th and 24th hours after surgery. Method of measurement: Quantitative frequency will be recorded on questionnaire.;Itching. Timepoint: During surgery and in the 1st, 4th and 24th after the surgery. Method of measurement: Quantitative frequency will be recorded on questionnaire.;Blood pressure (systolic and diastolic). Timepoint: The first 10 minutes will be measured every 3 minutes and then every 5 minutes till the end of the surgery. Post-operatively at the 1st, 4th and 24th hours. Method of measurement: Non-invasive blood pressure device.;Respiratory rate. Timepoint: Within the first 10 minutes every 3 minutes and then every 5 minutes till the end of the surgery. Post-operatively at the 1st, 4th and 24th hours. Method of measurement: Respiration monitoring by using Electrocardiograph device.;Sedation condition. Timepoint: During the surgery as well as in the 1st, 4th and 24th hours after surgery. Method of measurement: Ramsey Sedation Scale.;Assessment for infants health condition after delivery. Timepoint: 1st and 5th minutes of birth. Method of measurement: Apgar score.;Shivering. Timepoint: During the surgery and in the 1st, hours after surgery. Method of measurement: Quantitative frequency recorded on questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereydoon Fekrat

Bandare-abbas University of Medical Sciences

fereydoonfekrat@yahoo.com+98 76 3334 5009

Outcome results

None listed

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