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IRCT20140615018091N10 IRCT 2020-04-15 Bandare-abbas University of Medical Sciences Comparing the effect of adding morphine or pethidine to bupivacaine into the spinal space while producing numbness for cesarean section surgery on post-operative pain of pregnant women with a pregnancy age of over 37 weeks Comparing the effect of adding intrathecal morphine or pethidine to bupivacaine in spinal anesthesia during cesarean section surgery on post-operative pain of pregnant women with a gestational age of over 37 weeks 2017-06-05 anticipated 110 Complete https://irct.ir/trial/44270 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation software will be used to design a permuted block randomization table with a 1:1 allocation. Block sizes of 2, 4 and 6 will be used. According to the size of each block concealed opaque sequentially numbered envelopes containing the either assigned group A or B will be drawn. Allocation concealment and blinding to the block sizes will be applied to the primary anesthesiologist responsible for applying the study protocol, Blinding description: The following group of people involved in the blinding is: The participating parturients involved in the study will not be aware of the type of drug being injected intrathecally. However, written informed consent will be obtained from the participants. A second anesthesiologist who is participating in the trial but is not in charge of patient care will be responsible for collecting data in the operating room and will be blinded to the designation group of the pregnant participants and medications prescribed in the protocol. The medical student responsible for collecting the results of the study will also be blinded to the inclusion of parturients in the groups and the drugs prescribed in the protocol. 3 Condition 1: pregnancy. Condition 2: spinal anesthesia. Condition 3: hemodynamic changes. Condition 4: postoperative pain. Intervention 1: The first intervention group parturients while being in the sitting position, a Quincke needle No. 25 will be inserted into the lumbar space 3-4 or 4-5 and a total volume of 3 ml of a solution containing 12 mg of bupivacaine (0.5 %) )BUPIVACAINE MYLAN 20MG/4ML, Haupt Pharma Livron S.A.S. CO.) with 200 micrograms of morphine sulfate (Alborz Daru CO.) will be injected into the subarachnoid spaces. Intervention 2: ّThe second intervention group parturients while being in the sitting position, a Quincke needle No. 25 will be inserted into the lumbar space 3-4 or 4-5 and a total volume of 3 ml of a solution containing 12 mg of bupivacaine (0.5 %) )BUPIVACAINE MYLAN 20MG/4ML, Haupt Pharma Livron S.A.S CO.) with 20 mg of pethidine (Caspian Tamin CO.) will be injected into the subarachnoid spaces. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD will be available. When: Starting 12 months after publication. To whom: This will be only made available for people working in academic institutions. Conditions: The requests for review will be answered according to the policies provided by the body of regulations that is stated by the Vice-chancellor of research of Hormozgan University of medical sciences. Where to obtain: Requests can be sent to Dr. Abbas Moellemy at moallemyaln@yahoo.com How to obtain: The request for deidentified participant data review will be evaluated by the anesthesiology research center vice-chancellor and referred to the Hormozgan university vice-chancellor for assessing the eligibility of the requesting party this may take 1-3 months. Comments:
public Fereydoon Fekrat
Anesthesiology, Intensive care and Pain control research center, Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 fereydoonfekrat@yahoo.com Bandare-abbas University of Medical Sciences scientific Abbas Moallemy
Joomhoori Islami Blv., Shahid Mohammadi Hospital, Bandar Abbas, Iran
Bandar Abbas Iran (Islamic Republic of) 7919915519 +98 76 3334 5009 moallemyaln@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18-50 Gestational age of over 37 weeks American Society of Anesthesiologists physical status classes I and II Candidate for a cesarean section surgery 18 years 50 years Female Emergency cesarean section Limitations for applying regional block, Valvular heart disease A history of allergy to the target drugs Addicts Alcoholics Preeclampsia Diabetes Unwillingness to take part in the research G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs The first intervention group parturients while being in the sitting position, a Quincke needle No. 25 will be inserted into the lumbar space 3-4 or 4-5 and a total volume of 3 ml of a solution containing 12 mg of bupivacaine (0.5 %) )BUPIVACAINE MYLAN 20MG/4ML, Haupt Pharma Livron S.A.S. CO.) with 200 micrograms of morphine sulfate (Alborz Daru CO.) will be injected into the subarachnoid spaces. ّThe second intervention group parturients while being in the sitting position, a Quincke needle No. 25 will be inserted into the lumbar space 3-4 or 4-5 and a total volume of 3 ml of a solution containing 12 mg of bupivacaine (0.5 %) )BUPIVACAINE MYLAN 20MG/4ML, Haupt Pharma Livron S.A.S CO.) with 20 mg of pethidine (Caspian Tamin CO.) will be injected into the subarachnoid spaces. Severity of post surgical pain. Timepoint: 1st, 4th and 24th hours after surgery. Method of measurement: Numeric Rating Scale. The first demand for analgesia. Timepoint: after the surgery. Method of measurement: minutes after the surgery. Dose of the analgesic. Timepoint: after the surgery. Method of measurement: the number of diclofenac suppositories (100 mg) applied. Nausea and vomiting. Timepoint: 1st, 4th and 24th hours after surgery. Method of measurement: Quantitative frequency will be recorded on questionnaire. Itching. Timepoint: During surgery and in the 1st, 4th and 24th after the surgery. Method of measurement: Quantitative frequency will be recorded on questionnaire. Blood pressure (systolic and diastolic). Timepoint: The first 10 minutes will be measured every 3 minutes and then every 5 minutes till the end of the surgery. Post-operatively at the 1st, 4th and 24th hours. Method of measurement: Non-invasive blood pressure device. Respiratory rate. Timepoint: Within the first 10 minutes every 3 minutes and then every 5 minutes till the end of the surgery. Post-operatively at the 1st, 4th and 24th hours. Method of measurement: Respiration monitoring by using Electrocardiograph device. Sedation condition. Timepoint: During the surgery as well as in the 1st, 4th and 24th hours after surgery. Method of measurement: Ramsey Sedation Scale. Assessment for infants health condition after delivery. Timepoint: 1st and 5th minutes of birth. Method of measurement: Apgar score. Shivering. Timepoint: During the surgery and in the 1st, hours after surgery. Method of measurement: Quantitative frequency recorded on questionnaire. Bandare-abbas University of Medical Sciences Approved 2017-11-26 Ethics Committee of Hormozgan University of Medical Sciences Anesthesiology Research Center, Shahid Mohammadi Hospital, Islamic Republic Blvd. Bandar Abbas Hormozgan Iran (Islamic Republic of)