The effect of intraperitoneal instillation of Lidocaine on the postoperative pain after cesarean delivery
Design
Randomized clinical trial with parallel intervention and control group, in which 200 patients are randomly assigned to two groups of intervention and control.
Settings and conduct
This study is conducted at Ommol-Banin Hospital and on the pregnant women who are candidates for cesarean section surgery. They are randomly assigned to either the intraperitoneal instillation of Lidocaine or normal saline groups. The patient, surgeon and caregiver are unaware of the type of medication used for the mother.
Participants/Inclusion and exclusion criteria
Inclusion: All pregnant women with singleton pregnancy / candidate for elective cesarean section with spinal anesthesia / between 18 to 45 years / body mass index (BMI) less than 40 / one previous cesarean section with pfannenstiel incision.
Exclusion: history of other abdominal surgery / history of chronic pain / history of cardiac arrhythmia / Sensitivity to the drugs which are used in the intervention group.
Intervention groups
After delivery of the neonate and placenta, and the surgeon satisfaction with hemostasis, a sterile 20-mL syringe containing 2% lidocaine with epinephrine 1:200,000 is given to the surgeon. Then she carefully instills the study drug on the uterine peritoneal area by spraying two third of the drug around the uterine spaces and one third in the incision location. In the placebo group, this syringe will contain normal saline only.
Main outcome variables
The post - operative level of pain is measured at 6, 12, and 24 hours after the surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190227042862N1
Registration date:2019-05-23, 1398/03/02
Registration timing:retrospective
Last update:2019-05-23, 1398/03/02
Update count:0
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
Razieh Hadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 7762
Email address
hadir931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
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
The effect of intraperitoneal instillation of Lidocaine on the postoperative pain after cesarean delivery
Public title
The effect of intraperitoneal instillation of Lidocaine on the postoperative pain after cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women with singleton pregnancy
between 18 to 45 years
body mass index (BMI) less than 40
one previous cesarean section with pfannenstiel incision
candidate for elective cesarean section with spinal anesthesia
Exclusion criteria:
history of other abdominal surgery
history of chronic pain
history of cardiac arrhythmia
Sensitivity to the drugs which are used in the intervention group
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant women will be randomly assigned to one of the intervention or control groups by choosing one of the sealed envelopes (including the group name).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of receiving medication or placebo.
Syringes containing the medication or placebo have the same appearance and are given to the surgeon as coded syringes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-11-26, 1397/09/05
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.429
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82.0
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
Post-operative pain
Timepoint
6, 12 and 24 hours after cesarean section.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After delivery of the neonate and placenta, and the surgeon satisfaction with hemostasis, a sterile 20-mL syringe containing 2% lidocaine with epinephrine 1:200,000 is given to the surgeon. Then she carefully instills the study drug on the uterine peritoneal area by spraying two third of the drug around the uterine spaces and one third in the incision location.
Category
Treatment - Drugs
2
Description
Control group: After delivery of the neonate and placenta, and the surgeon satisfaction with hemostasis, a sterile 20-mL syringe containing normal saline is given to the surgeon. Then she carefully instills the study drug on the uterine peritoneal area by spraying two third of the drug around the uterine spaces and one third in the incision location.