Protocol summary

Study aim
Evaluate the effect of adding lidocaine to Patient Controlled Analgesia (PCA) with morphine on pain intensity after Cesarean section with spinal anesthesia
Design
Two arm parallel group, double blind, randomised clinical trial of 80 patients between October 2018 to December 2018.
Settings and conduct
Before anesthesia, venous access in the forearm of the nondominant hand of patients are established. Thirty minutes before the procedure, 7ml /kg of crystalloid serum will given to these patients and then spinal anesthesia will be performed. Patients will be placed in the sitting position, and the spinal puncture will perform in the L3-L4 and L4-L5 level with mid-line approach. Then 10-15 mg of Bupivacaine 0.5% will be administered for the patient and the T4 sensory level will provided. After completion of anesthesia and patients' recovery, all patients will connected to a Patient-controlled analgesia (PCA) pump.
Participants/Inclusion and exclusion criteria
Preliminary selection of patients will be done according to inclusion and exclusion criteria.The inclusion criteria included candidates for non-emergency cesarean section with the spinal anesthesia. Patients with known sensitivity to lidocaine or bupivacaine will be excluded.
Intervention groups
For patients in the intervention group, the PCA solution contain 50 ml of 2% lidocaine with 30 mg (3 ml) of morphine in 47 mL of normal saline (total volume 100 ml). In the control group, the PCA solution contain 30 mg of morphine (3 ml) in 97 ml of normal saline. The PCA will be set to administer a bolus dose of 0.5 mL with a lockout interval of 15 minutes and a background infusion rate of 2 mL/h.
Main outcome variables
The pain intensity of the patients in the two groups after surgery will be evaluated using the visual analogue scale (VAS) at 2, 4, 6, 12, 18 and 24 hours after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100713004365N23
Registration date: 2018-09-22, 1397/06/31
Registration timing: prospective

Last update: 2018-09-22, 1397/06/31
Update count: 0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-17, 1397/07/25
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adding lidocaine to Patient Controlled Analgesia (PCA) with morphine on pain intensity after cesarean section with spinal anesthesia
Public title
Effect of adding lidocaine to morphine for pain control after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's willingness to participate in the study and obtain informed consent Candidate for non-emergency cesarean section with spinal anesthesia Age between 45 and 20 years Class I of American Society of Anaesthesiologists (ASA) physical status Body mass index (BMI) less than 40 Parity 1 or 2
Exclusion criteria:
Known sensitivity to lidocaine or bupivacaine History of previous intra abdominal surgery Multiple pregnancy Pre-operative acute pain History of substance abuse and psychotropic drugs consumption Unwillingness to perform spinal anesthesia
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Before the start of the study, the list of subjects for 2 groups of the study will be determined randomly, using a computer-generated random list for 80 patients. Based on this list, envelopes in which the name of one of the treatment groups is written are prepared. These envelopes are placed in the operating room, and if patients meet the inclusion criteria, an envelope will be opened for each patient and their treatment group will be identified accordingly. This work will be done by an anesthetist technician.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind, and the data analyser, collaborative nurses who will asses the outcomes of the study and patients are unaware of the patients' treatment groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2017-04-04, 1396/01/15
Ethics committee reference number
IR.MAZUMS.REC.95.2528

Health conditions studied

1

Description of health condition studied
Cesarean section
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain

Primary outcomes

1

Description
Pain intensity after surgery
Timepoint
2, 4, 6, 12, 18 and 24 hours after surgery
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Satisfaction with pain control
Timepoint
24 hours after intervention
Method of measurement
Visual Analogue Scale

2

Description
Nausea
Timepoint
2, 4, 6, 12, 18 and 24 after surgery
Method of measurement
Visual Analogue Scale

3

Description
Length of hospital stay
Timepoint
Discharge from the hospital
Method of measurement
Patients record

4

Description
Amount of drug consumed through morphine pump
Timepoint
24 hours after intervention
Method of measurement
Patients record

5

Description
Return of normal bowel function
Timepoint
During the time of study
Method of measurement
Patients record

Intervention groups

1

Description
Intervention group: For patients in the intervention group, the PCA solution contain 50 ml of 2% lidocaine with 30 mg (3 ml) of morphine in 47 mL of normal saline (total volume 100 ml) which will be infused during the 24 hours. The PCA will be set to administer a bolus dose of 0.5 mL with a lockout interval of 15 minutes and a background infusion rate of 2 mL/h.
Category
Treatment - Drugs

2

Description
Control group: In the control group, the PCA solution contain 30 mg of morphine (3 ml) in 97 ml of normal saline which will be infused during the 24 hours. The PCA will be set to administer a bolus dose of 0.5 mL with a lockout interval of 15 minutes and a background infusion rate of 2 mL/h.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari Imam khomeini hospital
Full name of responsible person
Afshin Gholipour Baradari
Street address
Department of anesthesiology, Imam Khomeini hospital, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 1702
Email
gholipourafshin@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice chancellor for research, Moallem Square, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 4443 4210
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Imam khomeini hospital, Sari, Mazandaran, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 1702
Email
gholipourafshin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Imam Khomeini hospital, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3336 1700
Email
gholipourafshin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Imam Khomeini hospital, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 33361700
Email
gholipourafshin@yahoo.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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