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IRCT2013041212958N2 IRCT 2013-06-07 Tehran University of Medical Sciences The effect of ultra-low dose of naloxone on analgesia after abdominal wall nerves block in patients after cesarean section - The opioid sparing effect of adding ultra-low doses of naloxone to bupivacaine% 0/25 with or without sufentanil in Transverse Abdominis Plane Block on patients after elective caesarean section ;double- blind, randomized , clinical trial 2012-01-01 anticipated 164 Complete https://irct.ir/trial/12939 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A pain. Intervention 1: under guidence of ultrasonography Transverse abdominis Block performed bilateraly in control group "patients recieved 18 ml bupivacaine 0.25% along with 2 cc normal saline on each sideIn the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded . Intervention 2: under guidence of ultrasonography Transverse abdominis Block performed bilateraly in sufentanil group patients recieved 18 ml bupivacaine 0.25% along with 1 cc normal saline and 1 ml sufentanil (5 microgram) on each sideIn the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded. Intervention 3: under guidence of ultrasonography Transverse abdominis Block performed bilateraly in naloxone and sufentanil group patients recieved 18 ml bupivacaine 0.25% along with 1 cc naloxone (100 nanogram) alon with 5 microgram sufentanil on each side In the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded. Intervention 4: under guidence of ultrasonography Transverse abdominis Block performed bilateraly in Naloxone group patients recieved 18 ml bupivacaine 0.25% along with 1 cc normal saline alon with 100 nanogram (1 ml) Naloxone on each side In the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded.
public Samira Sorbi
Dr.Ali Shariati Hospital, North Karegar St.
Tehran Iran (Islamic Republic of) - +98 21 8490 2373 khatere80@yahoo.com Tehran University of Medical Sciences scientific Ali Movafegh
Dr.Ali Shariati, North Karegar St.
Tehran Iran (Islamic Republic of) - +98 21 8490 2397 movafegh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) inclusion criteria: age 20-40; ASA class I,II; primigravid; non addict; without history of allergy to protocol drugs Excluxion criteria: patients whom recieved drugs other than the ones mentioned in protocol in 24 h preoperation; surgery duration more than 90 minutes 20 years 40 years Female R52.0 acute pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs under guidence of ultrasonography Transverse abdominis Block performed bilateraly in control group "patients recieved 18 ml bupivacaine 0.25% along with 2 cc normal saline on each sideIn the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded . under guidence of ultrasonography Transverse abdominis Block performed bilateraly in sufentanil group patients recieved 18 ml bupivacaine 0.25% along with 1 cc normal saline and 1 ml sufentanil (5 microgram) on each sideIn the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded under guidence of ultrasonography Transverse abdominis Block performed bilateraly in naloxone and sufentanil group patients recieved 18 ml bupivacaine 0.25% along with 1 cc naloxone (100 nanogram) alon with 5 microgram sufentanil on each side In the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded under guidence of ultrasonography Transverse abdominis Block performed bilateraly in Naloxone group patients recieved 18 ml bupivacaine 0.25% along with 1 cc normal saline alon with 100 nanogram (1 ml) Naloxone on each side In the recovery room, pain intensity was measured at baseline then 2h, 6h, 12h, 24h postoperatively using visual analoge scale and the time of first request for analgesic and opioid consumption during 24 h postoperation also wrer recorded Pain intesity. Timepoint: recovery room,2,6,12,24 h after surgery. Method of measurement: visual analoge scale. Morphine consumption. Timepoint: recovery room, 2,6,12,24h after surgery. Method of measurement: opioid registration by milligram. Sensory Block Duration. Timepoint: 24h. Method of measurement: Pinprick test. Tehran University of Medical Sciences Approved 2012-09-26 Ethics Committee, Faculty of Medicine Faculty of Medicine, Tehran University of Medical Sciences and Health Care Tehran Iran (Islamic Republic of)