Protocol summary

Summary
Patients with major surgeries for gynecologic cancers need an appropriate protocol for control of acute postoperative pain. The aim of this study is to compare two techniques of intravenous patient control analgesia(PCA) and epidural PCA (PCEA) with a combined therapy in order to reach to an effective pain control with lower complications, earlier patient mobilization and lower admission time. 90 women with gynecologic malignancy who are candidate for surgery will be divided randomly in two groups . all patients will undergo to general anesthesia, group PCEA will receive epidural catheter from L3-L4 interspaces and only test dose will be administrated. After surgery, for group PCA analgesia medication will be infused, which contain 300 µg (6ml) fentanyl, 200mg((4ml) petidine and 8mg(2ml) ondansetron in Normal saline with the total volume of 100 ml. group 2 will receive Bupivacaine 0.5% 100 mg (24ml), fentanyl 150 µg (3ml) in Normal saline with total volume of 100 ml. rate of infusion in two groups will be 6-8 ml/h and blouse administration of 2 ml every 15 minute as needed. Severity of pain will control and record, at 2, 4. 6, 8, 12, 24, 36 and 48 hours postoperatively and during first patient mobilization. Additional analgesia with 0.1 mg / kg morphine will administrated if needed and will record. Any complication such as nausea, vomiting, respiratory depression, itching, sedation and in epidural group lower extremities parasthesia and any other complications evaluate and will record.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013071411700N2
Registration date: 2013-08-29, 1392/06/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-29, 1392/06/07
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Postoperative Pain after Gynecologic Oncologic Surgery Epidural and Intravenous
Public title
Comparison of Patient-Controlled Epidural Analgesia with Intravenous Patient-Controlled Analgesia on Postoperative Pain Control after Major Gynecologic Oncologic Surgery-A Randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women’s with gynecologic Oncologic Surgery in the operation list of Alzahra Hospital; Women’s with ASA class I and II; patients who wannt to contribute in the study Exclusion criteria: Women’s with ASA class III or higher; Severe cardiovascular diseases; Epidural anesthesia contraindications;Coagulation disorders or antiquagulant drugs using with therapeutic dose; Spin anomalies; Sepsis; Hypovolemic shock
Age
No age limit
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of medical Sciences
Street address
Daneshgah Ave, Tabriz University of medical Sciences
City
Tabriz
Postal code
Approval date
2013-03-11, 1391/12/21
Ethics committee reference number
91224

Health conditions studied

1

Description of health condition studied
Postoperative Pain Control after Gynecologic Oncologic Surgery
ICD-10 code
C51-58
ICD-10 code description
Malignant neoplasms of female genital organs

Primary outcomes

1

Description
Postoperative analgesia
Timepoint
Postoperative 2, 4, 6, 8, 12, 24 and 36 hours
Method of measurement
Severity os pain with Visual Analoge Scale(VAS)

Secondary outcomes

1

Description
Sedation
Timepoint
Posoperative 4, 6, 8, 12, 24, 36 hours
Method of measurement
Modified Ramsy sedation scale

2

Description
Patient's satisfaction
Timepoint
On the fifth day postoperative
Method of measurement
Score according to postoperative analgesia (nil = 0;

3

Description
Nausea and vomiting
Timepoint
Postoperative 2, 4, 6, 8, 12, 24, 36 hours
Method of measurement
Severity of Nausea and vomiting with Belville scorhng

Intervention groups

1

Description
After surgery, In recovery room for group one (IPCA) or which group that will receive intra venous PCA, analgesic will be infused, which contain 300 µg (6ml) fentanyl, 200mg (4ml) petidine and 8mg(2ml) ondansetron in Normal saline 0.9% with the total volume of 100 ml. First the speed of infusion will be ml/h 8-6, blouse administration of 2 ml every 15 minute are given by patient as needed.
Category
Treatment - Drugs

2

Description
Group 2 PCEA will receive epidural catheter from L3-L4 interspaces and only test dose(lidocaine 1.5% 3-4 ml and Epinephrine 1/200000) will be administrated. Group 2 will receive Bupivacaine 0.5% 100 mg fentanyl 150 µg (3ml)in Normal saline with total volume of 100 ml. Rate of infusion will be 6-8 ml/h and blouse administration of 2 ml every 15 minute as needed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr. Farnaz Moslemi
Street address
Alzahra Hospital, South artesh Ave
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Ellahi Saheb Madarek
Street address
Al Zahra hospital, South Artesh ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
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
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Position
Associate Professor, anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, south artesh Ave
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
moslemi_fa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Position
Associated Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
moslemi_fa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farnaz Moslemi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
+98 41 1556 6449
Email
moslemi_fa@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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