Protocol summary

Study aim
Comparison of bolus injection and continuous epidural infusion of lidocaine 1% on pain, normal delivery and motor function in patients with epidural analgesia
Design
50 patients are entered into a randomized, single-blind, phase 2-3 clinical trial and randomly assigned into 4 blocks and entered into one of the two groups of continuous and bolus epidural analgesia.
Settings and conduct
After placing catheter in epidural space, eligible patients in the Fatemieh Hospital of Hamedan received 10 ml of lidocaine 1% in epidural space and randomly placed in one of two groups of bolus or continuous and two types of analgesia is given . However, evaluator and patient do not know how to drug inject.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients aged 16 to 45; First pregnancy; Failure to receive previous analgesic; Vertex presentation; ASA class 1 and 2 Exclusion criteria: Epidural anesthetic contraindications (coagulation problems, hypovolemia, local infection, high ICP and anemia); ASA class 3 and 4; Poor collaboration in epidural analgesia; Failure to cooperate in answering questionnaire questions
Intervention groups
After placing catheter in epidural space, in both groups, 10 ml lidocaine 1% plus 1 ml of sufentanil is injected through the catheter into epidural space by anesthetist. Then, in bolus group, every 1 hour, 10 ml lidocaine 1% is injected regularly and in continuous group, lidocaine 1% is infused through a continuous infusion pump at a rate of 10 ml / h in epidural space until delivery.
Main outcome variables
Both groups are evaluated for VAS of pain and vital signs every 10 minutes. Also, total dose of lidocaine; nausea and vomiting; delivery progress; level of sensory and motor block and patient's satisfaction with analgesia during delivery is examined by anesthetic nurse and is recorded in questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N9
Registration date: 2018-08-24, 1397/06/02
Registration timing: registered_while_recruiting

Last update: 2018-08-24, 1397/06/02
Update count: 0
Registration date
2018-08-24, 1397/06/02
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
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of bolus epidural injection and continuous epidural infusion of lidocaine 1% on pain, normal delivery and motor function in patients with epidural analgesia
Public title
Epidural effects on labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with first pregnancy Aged 16 to 45 Failure to receive previous analgesic Vertex presentation ASA physical status class 1 and 2
Exclusion criteria:
Epidural anesthesia contraindications (coagulation problems, hypovolemia, localized infections, high ICP and anemia) patients with ASA physical status class 3 and 4 presence of lesions and skin infections on the lumbar and back of the patient patients with poor cooperation in performing of epidural analgesia patients who did not cooperate to answer the questionnaire questions).
Age
From 16 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
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 block. In this way, according to the sample size, 13 blocks of four 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)
Single blinded
Blinding description
After determining the epidural space and placing the catheter in the epidural space, in both groups, the 10 ml lidocaine 1% plus 1 ml of sufentanil is injected through the epidural catheter placed behind the patient. Then, in the bolus group, every one hour, 10 ml lidocaine 1% through an epidural catheter is bolusly injected into the epidural space by anesthesiologist regularly until delivery.In the continuous infusion group, lidocaine 1% is infused through a continuous infusion pump at a rate of 10 ml / h into the epidural space until delivery. The questionnaire is then completed by an anesthetist nurse. In this study, the evaluator and the patient do not know the type of drug administration as bolus and continuous infusion.
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
Mahdie Street, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.UMSHA.REC.1397.222

Health conditions studied

1

Description of health condition studied
Vaginal delivery under epidural 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
Labor pain
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
Using a Visual Analogue Scale, that patient marks his pain on a 10-cm ruler.

2

Description
Progress of labor
Timepoint
During labor
Method of measurement
Measurement of the duration of the first and second stages of labor

3

Description
Motor function
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
Using Bromage Score

Secondary outcomes

1

Description
Systolic Blood Pressure
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
Noninvasive blood pressure monitoring

2

Description
Diastolic Blood Pressure
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
Noninvasive blood pressure monitoring

3

Description
Mean Arterial Pressure
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
Noninvasive blood pressure monitoring

4

Description
Heart Rate
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
Noninvasive blood pressure monitoring

5

Description
satisfaction
Timepoint
After baby birth
Method of measurement
Ask the patient about the amount of satisfaction

6

Description
Total dose of lidocaine
Timepoint
After delivery and catheter exit
Method of measurement
Calculate the number of lidocaine ampoules

7

Description
Newborn Apgar
Timepoint
The first and fifth minutes after birth
Method of measurement
Examination and calculation on Apgar score

8

Description
Nausea & Vomiting
Timepoint
During the first and second stages of labor
Method of measurement
Observation and ask the patient

9

Description
Sedation
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
Using Ramsay Score

10

Description
Pruritus
Timepoint
Before and after epidural analgesia and minutes 10, 20, 30, 40, 50, 60 after epidural analgesia and the onset and end of the second stage of labor
Method of measurement
VAS Of Pruritus

11

Description
Paresthesia of Lip
Timepoint
During the first and second stages of labor
Method of measurement
Ask the patient

12

Description
The amount of ephedrine consumed
Timepoint
After delivery and catheter exit
Method of measurement
Calculate the amount of ephedrine consumed in mg

13

Description
Need to do cesarean section
Timepoint
After baby birth
Method of measurement
observation

Intervention groups

1

Description
First intervention group: In bolus group patients after receiving 500 ml of Ringer's serum and in sitting position, first with 18 G epidural needle (Tohy) in L3-L4 space and using the loss of resistance technique, we determine the epidural space. Then place the epidural catheter in the epidural space and In the bolus group, 10 ml of lidocaine 1% plus 1 ml of sufentanil is injected into the epidural space at the same time, and then every one hour 10 ml of lidocaine 1% is bolusly injected into the epidural space regularly until delivery by anesthesiologist.
Category
Treatment - Drugs

2

Description
Second intervention group: After receiving 500 ml of Ringer's serum and in sitting position, the first 18G epidural needle (Tohy) is inserted into space L3-L4 and using the loss of resistance technique, we determine the epidural space. Then the epidural catheter is placed in the epidural space and in the continuous infusion group, at first, 10 ml of lidocaine 1% plus 1 ml of sufentanil bolusly is injected into the epidural space, and Lidocaine 1% is then infused continuously at a rate of 10 ml / hour with continuous infusion pump that is adjusted by anesthesiologist and infused into the epidural space until delivery.
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
Saeed Bashirian
Street address
Mahdie Street, Hamadan University of Medical Sciences
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 Medical University
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
65177-89971
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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