Comparison of two methods of patient-controlled analgesia through intravenous and thoracic epidural to control pain and complications after surgery in esophageal cancer patients at the Cancer Institute of Imam Khomeini Hospital
Determining the difference between patient-controlled analgesia intravenously and thoracic epidural to control pain and complications after surgery in esophageal cancer patients
Design
Patients seeking esophageal cancer surgery were included in the study divided into two groups. The even file numbers of block A and odd were placed in block B. One group was implanted from the thoracic space (T6-8 level) before the start of epidural anesthesia and in the last half hour of the operation, an epidural analgesic pump with local anesthetic bupivacaine 0.125% - 4ml / hr was implanted and the other group after implantation. Anesthesia was connected to a peripheral vein pump at half an hour after the end of the operation and they underwent intravenous infusion of morphine 10mcg / kg / hr and ketorolac 120 mg / day. Pain and complications after surgery were compared.
Settings and conduct
The study was performed in the ICU and operating room of Imam Khomeini Hospital in Tehran. No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for esophageal cancer surgery.
Non-entry conditions: coagulation disorders, neurological disorders, movement disorders, drug addiction
Intervention groups
Intervention group 1: The group that was implanted from the thoracic space before the epidural anesthesia was started and in the last half hour of the epidural analgesia pump with local anesthesia was implanted.
Intervention group: The group that was connected to the patient from the peripheral vein after half anesthesia at the end of the operation and the patient underwent intravenous infusion
Main outcome variables
Second day postoperative pain; Third day postoperative pain; Duration of hospitalization in the ICU; Extra drug use required; Quarterly survival rate; Systolic blood pressure; Diastolic blood pressure; Pulse count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200929048879N1
Registration date:2020-12-06, 1399/09/16
Registration timing:retrospective
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Maziar Maghsoudloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 4431
Email address
mmaghsoudloo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2020-04-30, 1399/02/11
Trial completion date
2020-04-30, 1399/02/11
Scientific title
Comparison of two methods of patient-controlled analgesia through intravenous and thoracic epidural to control pain and complications after surgery in esophageal cancer patients at the Cancer Institute of Imam Khomeini Hospital
Public title
Comparison of two methods of patient-controlled analgesia through intravenous and thoracic epidural in surgery of esophageal cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have referred for esophageal cancer surgery.
Patients in the age range of 20 to 80 years who were candidates for esophageal cancer surgery.
Exclusion criteria:
Patients with coagulation disorders.
Infection of the epidural catheter insertion site
Patients with severe hemodynamic disorders.
Patients with severe movement disorders.
Patients with chest disorders.
Patients with neurological disorders.
Patients who are addicted to drugs.
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Candidate patients for esophageal cancer surgery were divided into two groups by random blocking and using a random number table. The even number of files will be in block A and the odd number in block B. To read counting numbers from top to bottom. Out of 80 randomly selected patients, 40 patients will be implanted in block A before the onset of epidural catheter anesthesia from the thoracic space and an epidural analgesic pump with local anesthetic will be implanted for patients around the end of the operation and 40 patients in block B After anesthesia and surgery near the end of the operation, a venous pump was connected to the peripheral vein for the patients and the patients will undergo intravenous infusion of narcotics and ketorolac. At the end, the two groups will be compared in terms of pain control and short-term complications.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Headquarters of Tehran University of Medical Sciences, corner of Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1997663786
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.199
Health conditions studied
1
Description of health condition studied
Control of pain and complications after surgery in esophageal cancer patients
ICD-10 code
MG30.10
ICD-10 code description
Chronic cancer pain
Primary outcomes
1
Description
Control of pain and complications after surgery in patients undergoing esophageal cancer surgery according to the Global Pain Assessment Tool (UPAT)
Timepoint
Before and during esophageal cancer surgery and during hospitalization in the ICU
Method of measurement
Using the Global Pain Assessment Tool (UPAT)
2
Description
Pain score on the second day after esophageal cancer surgery with Global Pain Assessment Tool (UPAT)
Timepoint
During hospitalization in the ICU
Method of measurement
Using the Global Pain Assessment Tool (UPAT)
3
Description
Pain score on the third day after esophageal cancer surgery with Global Pain Assessment Tool (UPAT)
Timepoint
During hospitalization in the ICU
Method of measurement
Using the Global Pain Assessment Tool (UPAT)
4
Description
Determining the length of hospital stay of patients in the ICU
Timepoint
During hospitalization in the ICU until transfer to the surgical ward
Method of measurement
Clinical symptoms of patients
5
Description
Extra drug use required based on patients' pain score
Timepoint
After esophageal cancer surgery and during hospitalization in the ICU
Method of measurement
Using the Global Pain Assessment Tool (UPAT)
6
Description
Quarterly survival rate
Timepoint
After surgery up to three months after discharge from the hospital
Method of measurement
Examination of the patient and questions and answers from the patient
7
Description
Systolic blood pressure
Timepoint
During surgery until the patient is discharged from the hospital
Method of measurement
Mercury sphygmomanometer
8
Description
Diastolic blood pressure
Timepoint
During surgery until the patient is discharged from the hospital
Method of measurement
Mercury sphygmomanometer
9
Description
Count the pulse
Timepoint
During surgery until the patient is discharged from the hospital
Method of measurement
Through standard patient heart rate monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who have had a thoracic catheter implanted before the epidural anesthesia and an epidural analgesic pump with a local anesthetic will be inserted around the end of the operation.
Category
Treatment - Devices
2
Description
Intervention group: Patients who after anesthesia and surgery near the end of the venous pump from the peripheral vein is connected to the patient and the patient will undergo intravenous infusion of narcotics and ketorolac