Comparison of intrathecal injection of fentanyl and sufentanil along with bupivacaine in the onset, duration and quality of painless labor; A randomized double-blind clinical trial
Comparison of intrathecal injection of fentanyl and sufentanil along with bupivacaine in onset, duration and quality of painless labor.
Design
A double-blind, randomized clinical trial with parallel groups design of 80 patients.
Settings and conduct
This study is conducted in Alzahra Hospital in Rasht. After explaining the purpose and method of the research, informed consent will be obtained. Pregnant mothers will be carefully placed in a sitting position.In sterile conditions, a 25-size needle will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and the injection will be performed.Pulse oximetry, blood pressure and electrocardiography will be evaluated continuously until the end of the operation. The sensory and motor block will be continuously monitored after injection.The pain score for labor analgesia will also be evaluated based on VAS. After transferring mothers to recovery and stabilization of vital signs, the level of satisfaction with the quality of analgesia will be measured by numerical rating scale (NRS).
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant mothers over 18 years with term pregnancy and single fetus and ASA class I or II, in the advanced stage of labor with cervical dilatation of at least 5 cm and tending to have painless labor
Inclusion criteria: obesity, endocrine disease, drug abuse, allergy to study drugs and regional anesthesia contraindications
Intervention groups
In the bupivacaine-fentanyl group, 2.5 milligrams of bupivacaine (manufactured by Aspen Company) and 25 micrograms of fentanyl (manufactured by Darupakhsh Company,Iran) and in the bupivacaine-sufentanil group, 2.5 milligrams of bupivacaine and 2.5 micrograms of sufentanil (manufactured by Aburihan Company, Iran) will be injected.
Main outcome variables
Labor pain score and pregnant mothers' satisfaction with the quality of analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230403057808N1
Registration date:2023-04-19, 1402/01/30
Registration timing:prospective
Last update:2023-04-19, 1402/01/30
Update count:0
Registration date
2023-04-19, 1402/01/30
Registrant information
Name
Samaneh Ghazanfar Tehran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9328
Email address
tehranisamaneh88rasht@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intrathecal injection of fentanyl and sufentanil along with bupivacaine in the onset, duration and quality of painless labor; A randomized double-blind clinical trial
Public title
Intrathecal injection of fentanyl and sufentanil along with bupivacaine in painless labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous or multiparous pregnant mothers with term pregnancy
Single fetus
American Society of Anesthesiologists' (ASA) classification I, II
In the advanced stage of labor with cervical dilation at least 5 centimeter in Primiparous and at least 4 centimeter in multiparous mothers
Age more than 18 years
Tending to have painless labor
Exclusion criteria:
Refusal to participate in the study by pregnant mothers
Obesity
Endocrine disease
Drug abuse
Allergy to study drugs
Regional anesthesia contraindications such as coagulopathy, high intracranial pressure and infection of injection site .
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible pregnant mothers who have given informed consent to participate in the study will be assigned to one of the two groups of bupivacaine with fentanyl and bupivacaine with sufentanil by an Anesthetist technician who is not involved in the study, with a random sequence in blocks of four created by computer (WinPepi software11.65), with the sequence of randomization blocks in a ratio of 1:1.Allocation concealment will be used for implementing the random sequence of participants in the study. So before assigning the person, the assigned group will not be This will prevent participants and researchers from knowing about the subsequent allocation. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. At the time of registration of eligible patients for the study, one of the envelopes will be opened and the patient will be a candidate for one of the two methods of analgesia.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to double-blind the study, the anesthesiologist who prepares the study drug also performs the neuraxial block in order to take the necessary actions in case of side effects. Data collection will be done by the anesthesia assistant responsible for the project. In this study, the pregnant mother and the evaluator will be unaware of the type of drug used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.GUMS.REC.1401.598
Health conditions studied
1
Description of health condition studied
Intrathecal injection of fentanyl and sufentanil in combination with bupivacaine in onset, duration and quality of painless labor
ICD-10 code
O75.9
ICD-10 code description
Complication of labor and delivery, unspecified
Primary outcomes
1
Description
Mean time of onset of sensory block
Timepoint
At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection
Method of measurement
Pinprick response in both lower limbs
2
Description
Mean time of duration of sensory block
Timepoint
At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection
Method of measurement
Pinprick response in both lower limbs
3
Description
The state of motor block
Timepoint
At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection
Method of measurement
Bromage test: zero (full flexion of knees and ankles), one (ability to move only knees), two (ability to move only legs), and three (inability to move knees and feet)
4
Description
Labor pain score
Timepoint
At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection
Method of measurement
Based on visual analog scale as 1-10
5
Description
Satisfaction status of pregnant mothers with the quality of analgesia
Timepoint
After transferring pregnant mothers to recovery and stabilization of vital signs
Method of measurement
Numerical Rating (NRS) based on percentage
Secondary outcomes
1
Description
Drug complications: (Blood pressure drop more than 20% of baseline, itching, chills, nausea and vomiting, cases leading to cesarean section)
Timepoint
The duration of the procedure
Method of measurement
Observance
Intervention groups
1
Description
Intervention group1: In sterile conditions, a 25-size needle (B.Brown company)will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and after ensuring the flow of cerebrospinal fluid, the injection will be performed. In the bupivacaine-fentanyl group, 2.5 milligrams of bupivacaine (manufactured by Aspen Company) will be injected with 25 micrograms of fentanyl (manufactured by Darupakhsh Company, Iran). The total volume of the solution is one milliliter.
Category
Treatment - Surgery
2
Description
Intervention group2 : In sterile conditions, a 25-size needle (B.Brown company)will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and after ensuring the flow of cerebrospinal fluid, the injection will be performed. In the bupivacaine-sufentanil group, 2.5 milligrams of bupivacaine (manufactured by Aspen Company) will be injected along with 2.5 micrograms of sufentanil (manufactured by Aburihan Company, Iran). The total volume of the solution is one milliliter.