Protocol summary
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Study aim
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Reduce pain and better recovery after cesarean section
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Design
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A clinical trial of 55 patients with two treatments parallel groups of 55 patients(Fentanyl and Dexmedetomidine,added to intrathecal Bupivacaine), double-blind, Randomised with Random allocation software
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Settings and conduct
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This study will be done at Hormozgan University of Medical Sciences. Spinal anesthesia were done in the sitting position through the aseptic technique using 25 G Quincke spinal needle at the L4-5 interspace. After observing free flow of CSF, the patients will randomly allocated into two groups (n= 55) as follows:
I.Group B-D received 10 mg hyperbaric Bupivacaine 0.5% + 5μg Dexmedetomidine [total volume of 2.5cc]
II.Group B-F received 10 mg hyperbaric Bupivacaine 0.5% + 25 μg Fentanyl [total volume of 2.5cc]
Hemodynamic parameters will be recorded in 0 minutes (immediately after injection), 5-10-15-30-60 minutes and in recovery.
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Participants/Inclusion and exclusion criteria
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110 pregnant women
Inclusion criteria: Gestational age ≥ 37 weeks and candidate for cesarean section by spinal anesthesia, and physical classes 1,2(ASA I, II)
Exclusion criteria: Emergency patients, patients with regional block bans, patients with heart valve disease, patients with a history of drug allergy, addictive or alcoholic patients, patients with placenta previa
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Intervention groups
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The first group received 10mg bupivacaine + 5μg dexmedetomidine
The second group received 10mg bupivacaine + 25μg fentanyl
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Main outcome variables
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Systolic blood pressure
Diastolic blood pressure
Mean arterial pressure
Arterial Oxygen Saturation Percentage
nausea and vomiting
Shivering
Apgar score
Postoperative pain
Duration of analgesia
General information
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Reason for update
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Problem writing
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110313006044N2
Registration date:
2020-02-15, 1398/11/26
Registration timing:
prospective
Last update:
2020-03-31, 1399/01/12
Update count:
1
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Registration date
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2020-02-15, 1398/11/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-20, 1398/12/01
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Expected recruitment end date
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2020-04-20, 1399/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of intrathecal administration of bupivacaine and fentanyl with bupivacaine and dexmedetomedine on postoperative analgesia in cesarean section
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Public title
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To investigate the effect of dexmedetomidine and fentanyl on spinal analgesia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidate for elective cesarean section and gestational age ≥ 37 weeks
Exclusion criteria:
Emergency patients
Patients with a ban on regional block
Patients with heart valve disease
Patients with a history of allergy to the drugs used
Addictive or alcoholic patients
Patients with placenta parvia
Patients who require medication during surgery because of incomplete blockage
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Age
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From 16 years old to 41 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed based on Random allocation software and based on that even numbers were considered for dexmedetomidine and odd numbers were considered for fentanyl accordingly.The numbers were put in closed envelopes and opened by a person other than the procedure handler, and according to which the drugs were prepared for injection they were given to the procedure physician while the doctor did not know the details of the syringes.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In order to eliminate bias from patient's awareness or anesthesia assistant and person who evaluate the results and its possible impact on the outcome of the study, the study will be conducted in a double-blind condition. After receiving written informed consent from patients, spinal anesthesia was done by given the same drugs and same volume to the anesthesiologist, then relevant information was recorded in the questionnaire by the anesthesiologist who was not aware of the injection of the drugs. It is obvious that the patient and the anesthesiologist were not aware of the type of drug being administered.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-03-14, 1394/12/24
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Ethics committee reference number
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IR.HUMS.REC.1394.185
Health conditions studied
1
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Description of health condition studied
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Cesarean section
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain rate and duration of analgesia
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Timepoint
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Measurement of pain and duration of analgesia in recovery and during 6-3 hours after surgery
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Method of measurement
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Patients' severity of pain is based on the Visual Analogues Scale, with the left side indicating no pain and the right side showing the number "10" indicating the most severe pain. Score style 1-3 indicates mild pain, 4-7 moderate pain, severe pain 8-10), duration of analgesia from time to block until patient requests for analgesics
Secondary outcomes
1
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Description
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Timepoint
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Method of measurement
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Intervention groups
1
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Description
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Intervention group 1: 10mg bupivacaine 0.5% + 5mg dexmedetomedine(PrecedexTM 200mcg/2ml Hospira, Inc,lake Forest, IL60045USA)
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: 10mg bupivacaine 0.5% + 25mg fentanyl(ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bandare-abbas University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data can be shared
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When the data will become available and for how long
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Starting the post-access period of the paper was accepted
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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All researchers
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From where data/document is obtainable
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Correspondence Dr Hashim Jarineshin contact by email hjarineshin@yahoo.com
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What processes are involved for a request to access data/document
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Details are available within a week at most
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Comments
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