Comparison the effects of intrathecal fentanyl, pethidine or placebo added to lidocaine and epinephrine on the duration of postoperative analgesia in spinal anesthesia for elective cesarean delivery.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201201128677N2

Enrollment

195

Registered

2012-01-19

Start date

2011-11-01

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

Pregnancy, childbirth and the puerperium. Other complications of anaesthesia during labour and delivery

Interventions

Intervention 1: Prescription of 25 microgram fentanyl and 75 mg lidocaine and 0.02mg epinephrine to intervention group. Intervention 2: Prescription 25 mg pethidine and 75 mg lidocaine and 0.02mg epin

Treatment - Drugs

Placebo

Prescription of 25 microgram fentanyl and 75 mg lidocaine and 0.02mg epinephrine to intervention group.

Prescription 25 mg pethidine and 75 mg lidocaine and 0.02mg epinephrine to intervention group.

Prescription of 1.5 ml normal saline and 75 mg lidocaine and 0.02mg epinephrine to control group

Eligibility

Sex/Gender

Female

Age

15 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: being candidate for elective cesarean delivery; ASA class 1&2 and signing informed consent. Exclusion criteria: addiction; contraindications for spinal anesthesia; hypersensitivity to opioids and local anesthetics; gestational hypertension; chronic itching; multi parity; having two or more surgery together and the duration of operation longer than 1.5 hours.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Determination of effect of added fentanyl or pethidine in compare with normal saline to lidocaine and epinephrine on the duration of postoperative analgesia in spinal anesthesia for elective cesarean delivery. Timepoint: After delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: By using VAS score with a scaled liner with scaling from 0 to 10.	—

Measure

Time frame

Determination of effect of added fentanyl or pethidine in compare with normal saline to lidocaine and epinephrine on the duration of postoperative analgesia in spinal anesthesia for elective cesarean delivery. Timepoint: After delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: By using VAS score with a scaled liner with scaling from 0 to 10.

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Secondary

Measure	Time frame
Determination of frequency of blood pressure decline after delivery in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Noninvasive blood pressure measuring.;Determination of frequency of nausea in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Questioning from patient(having or not).;Determination of frequency of vomiting in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Observation the patient.;Determination of infant’s APGAR in three groups. Timepoint: After infant’s birth and every 5 minute till the 20th minute. Method of measurement: APGAR score.;Determination of frequency of itching in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Questioning from patient(having or not).;Comparison of frequency of sedation in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Observation the patient.;Determination of frequency of respiratory depression in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Respiratory rate <8 and o2 saturation with pulse oxymeter.	—

Measure

Time frame

Determination of frequency of blood pressure decline after delivery in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Noninvasive blood pressure measuring.;Determination of frequency of nausea in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Questioning from patient(having or not).;Determination of frequency of vomiting in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Observation the patient.;Determination of infant’s APGAR in three groups. Timepoint: After infant’s birth and every 5 minute till the 20th minute. Method of measurement: APGAR score.;Determination of frequency of itching in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Questioning from patient(having or not).;Comparison of frequency of sedation in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Observation the patient.;Determination of frequency of respiratory depression in three groups. Timepoint: During delivery, then every 1 hour in the first 6 hours and every 2 hours in the latter 18 hours. Method of measurement: Respiratory rate <8 and o2 saturation with pulse oxymeter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarnoush Farzi

Guilan University of Medical Sciences

farnoush_farzi@gums.ac.ir+98 13 1322 5624

Outcome results

None listed

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