Evaluation of intraperitoneal injection of Ketamine and Ropivacaine to control and reduce postoperative pain cholecystectomy and reduce the need for postoperative analgesia
Design
Two-group clinical trial, with parallel groups, double-blind, randomized, phase 3 on 120 patients. The table of random numbers will be used for randomization.
Settings and conduct
The first group includes 60 patients who will receive 20 ml of Ropivacaine 0.5%. Before removing the trocar at the end of surgery, the drug will be injected into the peritoneum, in the Trendelenburg position, to facilitate the dispersion of the drug solution in the area of the liver, diaphragm, around the gallbladder, and near the hepatodeodenum ligament.
The second group consists of 60 patients who will receive 0.5 mg/kg of intraperitoneal Ketamine in 30 ml of diluted normal saline. Gallbladder and near hepatodeodenum ligament will be injected. Research site is Valiasr Hospital in Arak, Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged 18-60 years with the indication of laparoscopic cholecystectomy with a VAS score greater than or equal to 5. Exclusion criteria: allergy to Ketamine or Ropivacaine; cardiovascular, lung or mental illness; arbitrary use of any additional analgesics after surgery.
Intervention groups
In one group of patients with laparoscopic cholecystectomy, intraperitoneal injection of Ketamine will be performed and in another group, intraperitoneal injection of Ropivacaine will be performed.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220411054499N1
Registration date:2022-05-24, 1401/03/03
Registration timing:registered_while_recruiting
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Mohammad Amin Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 3057
Email address
m.eslami@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-24, 1401/03/03
Expected recruitment end date
2022-07-15, 1401/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intraperitoneal ropivacaine and ketamine on pain control after cholecystectomy
Public title
Comparison of the effect of ropivacaine and ketamine on pain control after cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-60 years old
Patients indicated for laparoscopic cholecystectomy
All patients with a VAS score equal or greater than 5
Exclusion criteria:
Hypersensitivity to Ketamine or Ropivacaine
Has cardiovascular, lung or mental illness
Arbitrary use of any additional painkillers after surgery
Patients indicated for open cholecystectomy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into 2 groups based on block random method in 4 and 8 formats using a table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, the data collector, and outcome assessor are unaware of the type of drug prescribed and the groupings.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2022-05-01, 1401/02/11
Ethics committee reference number
IR.ARAKMU.REC.1401.038
Health conditions studied
1
Description of health condition studied
Cholecystitis
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
Patients' pain based on visual analog scale
Timepoint
2, 4, 8, 12, 24 hours after surgery
Method of measurement
Use visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 0.5 mg / kg intraperitoneal Ketamine diluted in 30 ml of normal saline, which will be injected into the liver space at the end of the operation before removing the trocars in the Trendelenburg position.
Category
Rehabilitation
2
Description
Control group: injection of 20 ml of 0.5% Ropivacaine, which will be injected into the liver at the end of the operation before removing the trocars in the Trendlenberg position.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Mohammad Amin Eslami
Street address
Valiasr Hospital, Valiasr Squre, Shahid Shirodi Street