]>
IRCT2013040612918N1 IRCT 2014-09-08 Faculty of medicine of Tehran University of Medical Siences The effect of vitamin C injection before surgery in patient's pain control The effect of 2 grams vitamin C single dose IV injection compare with 20 ml of normal saline injection half an hour before laparoscopic cholecystectomy in pain and the patient's postoperative total opium usage in Shariati Hospital in 1393 2014-09-23 anticipated 110 Complete https://irct.ir/trial/12909 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Cholecystitis. Condition 2: post op use of opium. Condition 3: postoperative pain. Condition 4: post operative nausea and vomiting. Condition 5: surgical wound infection. Condition 6: calculus of gallbladder. Condition 7: calculus of ballblader without cholecystitis. Condition 8: calculus of gallbladder with other cholecystitis. Intervention 1: The intervention is one single dose of 2 grams of vitamin c of Osve pharmacological factory that made in IRAN ,that is equal to 4 vials of vitamin c that diluted with normal saline up to 20 cc and intravenously injected in the operation room after general anesthesia. Intervention 2: In the control group 20 cc normal saline injected intravenously after general anesthesia before surgery.
public Sara Emami
North Karegar street, Jalal Al Ahmad Highway
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2450 s_emami@razi.tums.ac.ir Dr Shariati Hospital, surgery ward scientific Dr Zhamak Khorgami
North Karegar street, Jalal Al Ahmad tree way street
Tehran Iran (Islamic Republic of) +98 21 8490 2450 khorgami@gmail.com Dr Shariati hospital Iran (Islamic Republic of) Inclusion Criteria: Patients who are considered for laparoscopic cholecystectomy (Laparoscopic surgery due to biliary Colic or cholecyctitis) Exclusion Criteria: Patients who are allergic to Narcotics or abusing drugs will be excluded from the study. In the case of necessity for simultaneous surgery, the patient will be excluded from the study. During 24- hour follow-up, Naloxone will be provided for the patients, and if patients’ respiratory rate drops below 12, PCA will be stopped and patient will be excluded from the study. no limit no limit Both k81.9 y45.0 r 10 r11 t81.4 k80.0 k80.2 k80.1 Cholecyctitis unspecified Opioids and related analgesics abdominal and pelvic pain Nausea and vomiting Infection following a procedure, not elsewhere classified calculus of gallbladder with acute cholecystitis calculus of ballblader without cholecystitis calculus of gallbladder with other cholecystitis Treatment - Drugs Placebo The intervention is one single dose of 2 grams of vitamin c of Osve pharmacological factory that made in IRAN ,that is equal to 4 vials of vitamin c that diluted with normal saline up to 20 cc and intravenously injected in the operation room after general anesthesia In the control group 20 cc normal saline injected intravenously after general anesthesia before surgery Amount of opium used. Timepoint: 6 and 24 hours after surgery. Method of measurement: patient controlled anesthesia. Nausea and vomiting. Timepoint: every 6 hours. Method of measurement: visual analoge scale. Wound infection. Timepoint: after 7 days. Method of measurement: physical examination. Patient satisfaction. Timepoint: after 24 hours. Method of measurement: sf 12 questionair. Urinary retention. Timepoint: during 24 hours. Method of measurement: examination. Faculty of medicine of Tehran University of Medical Siences Approved 2014-03-31 Research and technology center of Tehran University of Medical Siences Poorsina street, faculty of medicin of Tehran University of Medical Siences Tehran Iran (Islamic Republic of)