Comparison of intrathecal administration of bupivacaine and fentanyl with bupivacaine and dexmedetomedine on postoperative analgesia in cesarean section
Reduce pain and better recovery after cesarean section
Design
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
Settings and conduct
This study was done at Shariati Hospital of 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 were 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 (ROTEXMEDICA 0.5 mg/10ml 22946TRITTAU. Germany) [total volume of 2.5cc]
Then, the patients lied in the supine position. Hemodynamic parameters including systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate and spo2 were recorded in 0 minutes (immediately after injection), 5-10-15-30-60 minutes and in recovery.
Participants/Inclusion and exclusion criteria
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
Intervention groups
The first group received 10mg bupivacaine + 5μg dexmedetomidine
The second group received 10mg bupivacaine + 25μg fentanyl
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110313006044N2
Registration date:2020-02-15, 1398/11/26
Registration timing:retrospective
Last update:2020-02-15, 1398/11/26
Update count:1
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Hashem Jarineshin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 5009
Email address
hjarineshin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
2016-03-15, 1394/12/25
Actual recruitment end date
2016-10-19, 1395/07/28
Trial completion date
2016-12-21, 1395/10/01
Scientific title
Comparison of intrathecal administration of bupivacaine and fentanyl with bupivacaine and dexmedetomedine on postoperative analgesia in cesarean section
Public title
To investigate the effect of dexmedetomidine and fentanyl on spinal analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 16 years old to 41 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Hormozgan University of Medical Sciences
Street address
Jomhuri Blvd, Shahid Mohammadi Hospital
City
Bandar abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2016-03-14, 1394/12/24
Ethics committee reference number
IR.HUMS.REC.1394.185
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain rate and duration of analgesia
Timepoint
Measurement of pain and duration of analgesia in recovery and during 6-3 hours after surgery
Method of measurement
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