Protocol summary

Study aim
Comparison of intra techal injection of fentanyl and sufentanil on onset, duration and quality of analgesia in vaginal delivery under spinal anesthesia .
Design
50 patients are entered into a double-blind, phase 2-3 clinical trial and randomly assigned into 4 blocks and entered into one of the two groups of spinal analgesia by Fentanyl and Sufentanil.
Settings and conduct
In patients candidate for labor analgesia in Fatemiyeh Hospital of Hamadan ,randomly 1.5 ml fentanyl or sufentanil is injected intratechally .So that, patient, evaluator and anesthesiologist do not know the type of injected drug.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with class 1 and 2 of ASA ; Second pregnancy Gestational age 36 to 40 weeks; Aged 18 to 45 years ; Cervical dilatation is more than 5 cm Exclusion Criteria: Heart disease; Diabetes; Spinal anesthesia Contraindication ; History of opioid use in 24 hours before delivery.
Intervention groups
Patients were placed in a sitting position and 25 Quinke needle inserted into L3-L4 or L4-L5 space and after aspiration of cerebrospinal fluid , 1.5 ml of Fentanyl or Sufentanil(in group A or B) is injected into the subarachnoid space by an anesthetist who has no known medication .
Main outcome variables
After the spinal block, maternal vital signs; VAS of pain; maternal sedation score and FHR are determined every 5 minutes to 15 minutes, and then every 15 minutes to 3 hours.Time to reduce pain; duration of analgesia ; patient's satisfaction; Apgar score in the first and fifth minutes; duration of the first and second stages of labor; the need for cesarean section; itching; nausea and vomiting are also recorded in the questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N10
Registration date: 2018-12-12, 1397/09/21
Registration timing: registered_while_recruiting

Last update: 2018-12-12, 1397/09/21
Update count: 0
Registration date
2018-12-12, 1397/09/21
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra techal injection of fentanyl and sufentanil on the onset, duration and quality of analgesia in vaginal delivery under spinal anesthesia .
Public title
The effect of spinal opioids on labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with class 1 and 2 of physical status(ASA) The second pregnancy Gestational age 36 to 40 weeks Aged 18 to 45 years old Active phase of labor(Cervical dilatation is more than 5 cm)
Exclusion criteria:
Heart disease Diabetes Spinal anesthesia Contraindication(High ICP, coagulation problems, shock, anemia) History of opioid use in 24 hours before delivery
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization method is used as a 4-block . In this way, according to the sample size, 12 blocks are identified, and in each of these four blocks, two of each group will be written in the form of letters A or B. This means that two A and two B are written in each block, although the order of the writing of the four letters A and B will be different in each block. The periodic numbers table will then be used to determine the order of block selection.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients, after entering the operating room using Angiocath 18, received 500 ml of Ringer serum and patient's primary vital signs are measured by a non-invasive monitoring device. Then the patient is placed in a sitting position and placed under spinal anesthesia with spinal Quincke needle number 25 in L4-L5 or L3-L4 space, and after leaving the cerebrospinal fluid from the needle tip and correcting the subarachnoid space,1.5 ml of one of the two drugs fentanyl or sufentanil that prepared by an anesthetist nurse ((Which does not know the study)) in syringes of the same size and shape , is drawn into sterile syringe by anesthetist and is injected into the sub-arachnoid space, in each patient two groups A or B. Thus, the patient, anesthetist (assessor), and an analyzer are not aware of any prescriptive substance.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR. UMSHA .REC.1397.223

Health conditions studied

1

Description of health condition studied
Vaginal delivery under spinal analgesia
ICD-10 code
074.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery

Primary outcomes

1

Description
Time to start analgesia
Timepoint
After doing spinal analgesia
Method of measurement
Calculation of the time from the moment of spinal analgesia is just the feeling of pain relief by the patient

2

Description
Duration of analgesia
Timepoint
Since the reduction in the patient's pain until the restart of pain
Method of measurement
Calculate the time when the vas of pain decreases to less than 4 until vas of pain increases again to more than 4.

3

Description
Quality of analgesia
Timepoint
After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours
Method of measurement
Use a 10-cm ruler to determine the vas of pain by patient

Secondary outcomes

1

Description
Mother's heart rate
Timepoint
After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours
Method of measurement
Pulse oximetry device

2

Description
Duration of the first stage of labor
Timepoint
Since the onset of labor pain before the baby's birth
Method of measurement
Calculate the dilation time of cervix at 5 cm to the full dilation of cervix.

3

Description
Duration of the second stage of labor
Timepoint
After baby birth
Method of measurement
Calculation from the time of full dilation of cervix until birth time of the baby

4

Description
Sedation Score
Timepoint
After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours
Method of measurement
Ramsay Score

5

Description
Nausea and vomiting
Timepoint
During the first and second stages of Labor
Method of measurement
Observation and ask the patient

6

Description
Itching
Timepoint
During the first and second stages of Labor
Method of measurement
Observation

7

Description
Baby Apgar
Timepoint
The first and fifth minutes after birth of the baby
Method of measurement
Apgar Score

8

Description
Fetal heart rate
Timepoint
After performing spinal analgesia every 5 minutes to 15 minutes and then every 15 minutes to 3 hours
Method of measurement
Fetal heart monitoring device

9

Description
Need to do cesarean section
Timepoint
During the first and second stages of Labor
Method of measurement
Seeing the transfer to the operating room for cesarean section

10

Description
Satisfaction
Timepoint
After baby birth
Method of measurement
Ask the patient

Intervention groups

1

Description
First intervention group: After receiving 500 ml of Ringer's serum patients were placed in a sitting position after and 25 Quinke needle inserted into L3-L4 or L4-L5 space and after observing the coming out of cerebro spinal fluid from the sub arachnoid space, in the first group(A), 1.5 ml of fentanyl is injected by an anesthetist who has no known medication in sterile syringe and injected into the subarachnoid space.
Category
Treatment - Drugs

2

Description
Second intervention group: After receiving 500 ml of Ringer's serum patients were placed in a sitting position after and 25 Quinke needle inserted into L3-L4 or L4-L5 space and after observing the coming out of cerebrospinal fluid from the sub arachnoid space, In the second group(B), 1.5 ml of sufentanyl is injected by an anesthetist who has no known medication in sterile syringe and injected into the subarachnoid space.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
hp.fatemieh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
65177899
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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