]>
IRCT201012115363N1 IRCT 2011-01-28 Vice- Chancellor for Research of Zanjan University The Effect of Intrathecal Betamethasone on Post Operative Pain Relief after Cesarean Section. The Effect of Intrathecal Betamethasone on Post Operative Pain Relief after Cesarean Section in Mosavi Hospital. 2009-10-23 anticipated 99 Complete https://irct.ir/trial/5751 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1 post operative pain. Intervention 1: Group 2 (IT): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received normal saline 0.5 mL IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml preservative free betamethasone (4 mg/ml) intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia. Intervention 2: Group 1 (Control): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room, routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received normal saline 0.5 mL IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia. Intervention 3: Group 3 (IV): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received betamethasone 0.5 mL IV (4 mg/ml) with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia.
public Dr Faramarz Dobakhti
Faculty of pharmacy, Zanjan University of Medical Sciences
Zanjan Iran (Islamic Republic of) +98 24 1427 3636 fdobakhti@zums.ac.ir Zanjan University of Medical Sciences scientific Dr Taraneh Naghibi
Mosavi hospital, Gavazang Blvd, Zanjan, Iran
Zanjan Iran (Islamic Republic of) +98 24 1424 2712 tnaghibi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: ASA class I and II, age between 20 and 40 years old, scheduled to undergo Cesarean Section Exclusion criteria: Receiving analgesics or corticosteroids drugs, presence of contraindication to regional anesthesia, known hypersensitivity to the study drugs or if having any history of cardiac, respiratory, neuromuscular, Hepatic or renal disease, unwilling to participate 20 years 40 years Female R52.0 Acute pain Treatment - Drugs Treatment - Drugs Treatment - Drugs Group 2 (IT): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received normal saline 0.5 mL IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml preservative free betamethasone (4 mg/ml) intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia. Group 1 (Control): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room, routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received normal saline 0.5 mL IV with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia. Group 3 (IV): Visual analogue scale for pain was explained to all patients during the preoperative visit. In the operating room routine monitors were established (electrocardiogram, non-invasive blood pressure monitor and pulse oximeter). A 16 gauge intravenous canula was sited. An intravenous preload of 5 ml/kg of lactated Ringer’s solution was given before dural puncture. Spinal puncture was performed at the L3-4 space with a 23-gauge Quincke needle by using a midline approach. The patients received betamethasone 0.5 mL IV (4 mg/ml) with 3 ml of 0.5% heavy bupivacaine plus 0.5 ml of 0.9% saline intrathecally. After surgery, diclofenac, 100 mg in suppository form was administrated as needed for analgesia. Severity of pain. Timepoint: 4, 6, 12, 24 h after operation. Method of measurement: VAS-consisting of 100 mm line with 0 = no pain and 100 = worst possible pain. Number of used suppository. Timepoint: 24 hrs after surgery. Method of measurement: Asking from Patient. Nausea and vomiting intraoperatively. Timepoint: At the end of the surgery. Method of measurement: Asking from Patient. Nausea and vomiting postoperatively. Timepoint: 24 hrs after surgery. Method of measurement: Asking from Patient. Headache after surgery. Timepoint: 24 hrs after surgery. Method of measurement: Asking from Patient. Time to rescue analgesic drug for the first time. Timepoint: Whenever the VAS goes higher than 4. Method of measurement: Asking from Patient. Vice- Chancellor for Research of Zanjan University Approved 2009-09-18 Zanjan University of Medical Sciences Azadi Blvd., Zanjan, Iran Zanjan Iran (Islamic Republic of)