Analgesic effect and complications of thoracic epidural analgesia compared with IV- PCA(patient controlled analgesia ) in patients under thoracic and upper abdominal surgeries
Objective: comparing analgesic effects and postoperative complications between the Epidural analgesia and IV-PCA in patients under thoracic and upper abdominal surgery. Design: a randomized clinical trial is conducted. Population: inclusion criteria: 18-70 years old patients who were candidate for thoracic or upper abdominal surgery with ASA CLASS less than 3; exclusion criteria: history of prolonged use of NSAIDs and need to continue them, drug addiction, lower extremity neurologic disorders, history of coagulation disorders and ASA CLASS > 2 . The amount of pain before surgery is recorded using VAS and Verbal scale before surgery in both groups. In the epidural analgesia group, 30 minutes before general anesthesia, a catheter in the epidural space of T7-T8 or T8-T9 fixed and after surgery, 6 to 8 ml of 0.125% bupivacaine and 2 mg of morphine injected into the catheter and is repeated every 8 hours if necessary. In PCA group, after surgery, morphine (1mg/ml) to the 2.5 ml (with 10-minute intervals by the patient) will be injected through a PCA pump. The complication of analgesic methods and the amount of analgesia will be record every 24 hours to 72 hours after the operation. Intervention is performed after admission the patient in the operating room. The primary outcome is acute postoperative pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112318566N1
Registration date:2012-01-31, 1390/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-31, 1390/11/11
Registrant information
Name
Vahideh Shahnazari
Name of organization / entity
Hamedan Univercity Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 9252
Email address
v.shahnazari@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan Univercity Of Medical Siences-vice chancellor for research
Expected recruitment start date
2012-01-05, 1390/10/15
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effect and complications of thoracic epidural analgesia compared with IV- PCA(patient controlled analgesia ) in patients under thoracic and upper abdominal surgeries
Public title
Epidural analgesia and PCA in pain relief after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who were candidate for thoracic or upper abdominal surgeries; between 18 to 70 years old and ASA class<3.
Exclusion criteria: history of NSAIDs usage for long times; ASA class >2; history of coagulation disorders; allergic reactions to local anesthetic drugs; patient inability for use of PCA pump; presence of significant neurologic disorders in lower limbs and addiction to opioid.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
N/A
Randomization description
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
Hamedan Univercity of Medical Siences Ethics Committee
Street address
Mahdiye Street, Hamedan Univercity of Medical Siencies
City
Hamedan
Postal code
Approval date
2012-01-04, 1390/10/14
Ethics committee reference number
3552/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Acute postoperative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Acute postoperative pain
Timepoint
Every 24 hours to 72 hours
Method of measurement
Measurement of pain as Verbal, VAS
Secondary outcomes
1
Description
Complications of analgesic method that used for patient
Timepoint
Every 24 hours to 72 hours
Method of measurement
At the time of any symptoms such as itching, nausea and vomiting, significant increase or decreas (over 20%) of blood presure ,respiratory depression and paresthesia or motor weakness of lower limbs.
Intervention groups
1
Description
Intervention in epidural group patients: after the replacement of the intravenous catheter and infusion of 500CC normal saline, 30 minutes before surgery, thoracic epidural catheter 20G through 18G needle in the intervertebral space T8-T9 or T7-T8 with Loss of resistance is placed in a sitting position. After fixing the catheter patients will undergo non-invasive monitors. A Test dose of bupivacaine% 0.25: 5ml with epinephrine 1 / 200000: 1ml is injected through the catheter. For surgical procedure all patients receive midazolam, fentanyl, thiopental and muscle relaxant for induction of anesthesia. In postoperative period a pharmaceutical composition containing 2mg of morphine and 6-8ml of 0.125% bupivacaine is injected through epidural catheter every 8 hours. Control of blood pressure and heart rate will be performed before induction of anesthesia and after transmit ion to the surgical ward, then will be recorded every 24 hours to 72 hours after the operation.
Category
Treatment - Drugs
2
Description
Intervention in PCA group: patients will be educated for proper use of PCA system in preoperative and postoperative periods. After surgery, morphine (1mg/ml) to the 2.5 ml (within 10-minute intervals by the patient) will be injected through a PCA pump. After surgery, patients with certain commands for analgesia are transmitted to the ward. In all patients every 24 hours to 72 hours after surgery, amount of analgesia and the rate of complications, including complications due to surgery will be recorded. While patients are being discharged, they are questioned to determine the level of satisfaction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
BESAT Hospital
Full name of responsible person
Dr Vahideh Shahnazari
Street address
BESAT Hospital, General Operation Room, Motahhari Avenue, Resalat Square, Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan Univercity of Medical Sciences- vice chancellor for research
Full name of responsible person
Dr Haydar Tavilani
Street address
Hamedan Univercity of Medical Sciences, Mahdie Avenue
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan Univercity of Medical Sciences- vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan Univercity of Medical Sciences
Full name of responsible person
Dr Vahideh Shahnazari
Position
MD, Anesthesiology Resident
Other areas of specialty/work
Street address
BESAT Hospital, General Operation Room, Motahhari Avenue, Resalat Square, Hamedan