Aim: comparing the pain severity after laparoscopic cholecystectomy with intra-peritoneal injection of bupivacaine, morphine, hydrocortisone in 5th Azar hospital, 2016-2017
Design: double blind randomized phase 3 clinical trial, single center
Study population: Cases candidate for cholecystectomy by laparoscopic method allocated in 3 groups
Inclusion criteria:cases ages 20-50 years old with class I and II ASA
Exclusion criteria: Consumption of opioids or sedative before operation, hematologic or neurologic diseases
Intervention: intra-peritoneal injection of bupivacaine, morphine, hydrocortisone
Intervention time: at the end of operation
Outcome measures: Lowering the pain after operation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703011264N9
Registration date:2017-05-27, 1396/03/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-27, 1396/03/06
Registrant information
Name
Sima Besharat
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1224 4170
Email address
besharat@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain severity after intraperitoneal injection of bupivacaine, morphine, hydrocortisone in laparoscopic cholecystectomy
Public title
Comparison of pain severity after intraperitoneal injection of bupivacaine, morphine, hydrocortisone in laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for laparoscopic cholecystectomy; age between 20 to 50 years; Class I and II ASA
Exclusion criteria:
Opioid consumption during 24 hours before the operation; Chronic fatigue syndrome; Inability to report pain; Steroid therapy; Neurologic diseases; Taking NSAIDs; Acute cholecystitis; Other kind of cholelithiasis (other than gall bladder); Hematological disorders; Neuromuscular diseases
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Falsafi educational complex, 2 km from Gorgan to Sari
City
Gorgan
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.GOUMS.REC.1396.3
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain reduction
Timepoint
Hours 0.5-1-4-8-16 after the surgery
Method of measurement
VAS scale
Secondary outcomes
1
Description
Time of bowel function onset
Timepoint
Hours 6-12-24 after the surgery
Method of measurement
Personal report
2
Description
Nausea and vomiting
Timepoint
Hours 0.5-1-4-8-12-16 after the surger
Method of measurement
Personal report
3
Description
Time of oral nutriton
Timepoint
Hours 6-12-24 after the surgery
Method of measurement
Personal report
4
Description
Time of movement without help
Timepoint
Hours 6-12-24 after the surgery
Method of measurement
Personal report
Intervention groups
1
Description
Intra-peritoneal injection of 30 cc Bupivacaine 0.25%
Category
Treatment - Drugs
2
Description
Intra-peritoneal injection of 30 cc Bupivacaine 0.25% plus 2 milligram Morphine
Category
Treatment - Drugs
3
Description
Intr-peritoneal injection of 200 milligram Hydrocortisone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5th Azar hospital, Gorgan
Full name of responsible person
Dr. Maryam Zahedi Tabarestani
Street address
5th Azar Hospital, 5th Azar St, Gorgan city
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Golestan University of Medical Sciences