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IRCT20160103025821N4 IRCT 2018-07-17 Tabriz University of Medical Sciences Comparison of the complications spinal analgesia with Spinal-Epidural Analgesia in natural delivery Comparison of the complications of Labour analgesia with Spinal or Combined Spinal-Epidural Analgesia 2018-06-15 anticipated 90 Complete https://irct.ir/trial/32082 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A the complications of Labour analgesia. Intervention 1: Intervention group: Spinal analgesia group: during delivery 25 to 50 microgram intrathecal fentanyl injection to L4-L5 as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration. Intervention 2: Intervention group: Combined spinal-epidural group: during delivery intrathecal injection of 3 millimeter 1.5% lidocaine combined with 8 to 10 milligram of 5 mg/ml bupivacaine with 0.0625 saturation with 50 microgram fentanyl injection following by 25 to 50 microgram fentanyl injection to subarachnoid space combined with 2.5 milligram bupivacaine to. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr.hojjat Pourfathi
Talghani hospital, Rah ahan square, Tabriz
Tabriz Iran (Islamic Republic of) 34424882 +98 41 3441 2000 pourfathih@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr.hojjat pourfathi
Talghani hospital, Rah ahan square, Tabriz
Tabriz Iran (Islamic Republic of) 34424882 +98 41 3441 2000 pourfathih@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) There is a possibility of natural birth mother's consent to reduce delivery pain no limit no limit Female mother's disinclination to participate Inability to maintain immobility during procedure Coagulation disorders and defects in homeostasis Increased intracranial pressure for any reason Frank infection at the needle site Hypersensitivity to local anesthetics or other medications using in this methods Acute lesions of the central nervous system Maternal hemodynamic instability (hypovolemia, hypotension) Heart diseases that cardiac output is severely limited fetal distress Prevention Prevention Intervention group: Spinal analgesia group: during delivery 25 to 50 microgram intrathecal fentanyl injection to L4-L5 as opioid combined with 2.5 milligram bupivacaine to enhance analgesia quality and duration Intervention group: Combined spinal-epidural group: during delivery intrathecal injection of 3 millimeter 1.5% lidocaine combined with 8 to 10 milligram of 5 mg/ml bupivacaine with 0.0625 saturation with 50 microgram fentanyl injection following by 25 to 50 microgram fentanyl injection to subarachnoid space combined with 2.5 milligram bupivacaine to Hypotension. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: Monitoring, Sphygmomanometer tool. Pruritus. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History. Headache. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History. Backpain. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History. Urinary incontinence. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: History. Respiratory depression. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute ,after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: PHysical examination. Complete Spinal Block. Timepoint: Immediately after the intervention, after 5 minute, after 10 minute, after 20 minute, after 40 minute, after 60 minute, after 1.5 hour, after 2 hour, after 3 hour, . Method of measurement: PHysical examination. Fetal heart rate. Timepoint: Before the intervention, Immediately after the intervention, Every 5 minutes until delivery, Immediately after delivery. Method of measurement: PHysical examination. Studied groups. Timepoint: mmediately after the intervention, after 5 minute,after10 minute,after20minute,afer40minute,after60minute,afer1.5hour,after2hour,after3hour,. Method of measurement: check list. Tabriz University of Medical Sciences Approved 2018-06-11 Ethics committee of the research and technology department, Tabriz University of Medical sciences Research department, Daneshghah street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)