1)objective: Intrathecal analgesia in labor has become an established technique, and various local anesthetics and opioids have been used, either alone or in combination. The use of intrathecal bupivacaine with sufentanil has been described for labor, but dosages have been arbitrarily chosen with little knowledge of their contribution to the overall effectiveness of analgesia. The aim of this study was to assess the analgesic effects and possible side-effects of two different doses of intrathecal bupivacaine added to sufentanil in women in the first stage of labor.
2)Design: Randomized-double blinded placebo controlled clinical trial; one center; phase 2 clinical trial
(3) Setting and conduct: we compared the analgesic effects and possible side-effects of different dosages of intrathecal bupivacaine (one and two milligram) added to 5 microgram sufentanil in 40 parturient women (20 patients in each group) in the first stage of labor.
(4) Participants including major eligibility criteria: Inclusion criteria: ASA 1 primigravid singletone parturients with gestational age (36-40 wk) in active phase of labor.
Exclusion criteria: Use of analgesic or opioids in recent 12 hours; chronic hypertension; preeclampsia; gestational diabetes; allergy to drugs; cardiovascular disease; coagulopathy.
(5) Intervention: َSpinal injection consisted 5 microgram sufentanil combined with 1 or 2 mg of bupivacaine from the L4-L5 or L3-L4 interspace with the patient in the sitting position.
(6) main outcome measures (variables): onset of analgesia and time from spinal injection until the relief of labor pain wich were measured every 5 minutes after spinal injection in the first 15 min after spinal injection
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701168768N5
Registration date:2017-02-07, 1395/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-07, 1395/11/19
Registrant information
Name
Mahshid Nikooseresht
Name of organization / entity
Hamadan university of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 5383
Email address
nikooseresht@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effects of one and two miligram bupivacaine added to intrathecal sufentanil on labor analgesia
Public title
Comparison of different doses of bupivacaine in labor spinal analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA 1 primigravid singletone parturients with gestational age (36-40 wk) in active phase of labor (cervix dilation 4-6 cm)
Exclusion criteria: Use of analgesic or opioids in recent 12 hours; chronic hypertension; preeclampsia; gestational diabetes; allergy to drugs; cardiovascular disease; coagulopathy
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Ethics in Research, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
65178
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.UMSHA.REC.1395.348
Health conditions studied
1
Description of health condition studied
labor analgesia
ICD-10 code
074.9
ICD-10 code description
Complication of anaesthesia during labour and delivery, unspecified
Primary outcomes
1
Description
onset of analgesia
Timepoint
every 5 minutes after spinal injection
Method of measurement
Time from spinal injection until the relief of labor pain in the first 15 min such that the subject did not request rescue medication.(pain VAS<4)
2
Description
duration of analgesia
Timepoint
every 15 minutes after spinal injection
Method of measurement
Time from spinal injection until the end of spinal analgesia.(minute)
Secondary outcomes
1
Description
pruritus
Timepoint
every 15 minutes after spinal injection until the end of spinal analgesia
Method of measurement
VAS for pruritus (0-10)
2
Description
nausea and vomiting
Timepoint
every 15 minutes after spinal injection until the end of spinal analgesia
Method of measurement
yes/no question from patient
3
Description
motor bockade
Timepoint
every 15 minutes after spinal injection
Method of measurement
Bromage Scale (1=no motor block--ability to raise extended leg against gravity; 2 = inability to raise extended leg, able to bend knee; 3 = inability to bend knee, able to flex ankle; and 4 = complete motor block) were assessed at the 3 levels.
4
Description
Neonatal Apgar score
Timepoint
1 and 5 minutes after birth
Method of measurement
Apgar scale
5
Description
sensory level to cold and pinprick
Timepoint
15 minutes after spinal injection
Method of measurement
question from patient in response to cold and pinprick (dermatomal level)
Intervention groups
1
Description
Intervention 1: َSpinal injection consisted 5 microgram sufentanil with 1 mg of bupivacaine from the L4-L5 or L3-L4 interspace with the patient in the sitting position.
Category
Treatment - Drugs
2
Description
Intervention 2: Spinal injection consisted 5 microgram sufentanil with 2 mg of bupivacaine from the L4-L5 or L3-L4 interspace with the patient in the sitting position.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Mahshid Nikooseresht
Street address
Pasdaran Street, Shariati square, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Full name of responsible person
Saiid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmideh street, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahshid Nikooseresht M.D
Position
Assistant Professor of Anesthsiology, Fellowship of Pain managenent