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IRCT201201128677N2 IRCT 2012-01-19 Vice Chancellor for research, Guilan University of Medical Sciences 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. 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. 2011-11-01 anticipated 195 Complete https://irct.ir/trial/9162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Pregnancy, childbirth and the puerperium. 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 epinephrine to intervention group. Intervention 3: Prescription of 1.5 ml normal saline and 75 mg lidocaine and 0.02mg epinephrine to control group.
public Farnoush Farzi
Reproduction Health Research Center, Al-Zahra hospital, Namjo street
Rasht Iran (Islamic Republic of) +98 13 1322 5624 farnoush_farzi@gums.ac.ir Guilan University of Medical Sciences scientific Farnoush Farzi
Reproduction Health Research Center, Al-Zahra hospital, Namjo street
Rasht Iran (Islamic Republic of) +98 13 1322 5624 farnoush_farzi@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) 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. 15 years 40 years Female O74.8 Other complications of anaesthesia during labour and delivery Treatment - Drugs 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 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. 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. Vice Chancellor for research, Guilan University of Medical Sciences Approved 2011-10-31 Ethic committee Guilan University of Medical Sciences Melat st, Namjoo Ave Rasht Iran (Islamic Republic of)