Comparison of analgesia and side effects in Fentanyl epidural and Fentanyl, Bupivacaine epidural after spinal surgery Spondylolisthesis surgery and Spinal fixation Spondylolisthesis surgery and Spinal fixation
The objective of this study is to compare of analgesic effect and side effects in Fentanyl epidural and Fentanyl - Bupivacaine epidural after Spondylolisthesis surgery and Spinal fixation.Inclusion criteria: Ninety patients aged 18 to 75 years underwent Spondylolisthesis and spinal fixation surgery and had not mental disorder, hepatic or renal failure and addiction. Exclusion criteria: Dural damage; exclusion of epidural catheter; Patient dissatisfaction. Patients with random block classification were divided into 3 groups. First group: intravenous Morphine if was needed (control group), second group: epidural Fentanyl and third group: Epidural Fentanyl and Bupivacain.In both groups epidural Fentanyl and epidural Fentanyl, Bupivacain group, surgeon put an epidural catheter in the epidural space at the end of operation .These drugs infusion after patient arrival to recovery unit. For primary pain control Apotel 1 gram in 100 cc normal saline will be infused 20 minutes prior to the end of surgery, then repeat every 6 hours. Blood pressure, Heart rate, Respiratory rate and pain score were monitored and documented when patient were transferred from recovery unit to the section and 4 hours after surgery, then every 6 hours up to 24 hours. Our goal is to get the best postoperative analgesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031016917N1
Registration date:2014-06-27, 1393/04/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
Registrant information
Name
Ali Ashraf
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 0434
Email address
aliashraf@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesia and side effects in Fentanyl epidural and Fentanyl, Bupivacaine epidural after spinal surgery Spondylolisthesis surgery and Spinal fixation Spondylolisthesis surgery and Spinal fixation
Public title
Relevance analgesia and side effects with Fentanyl epidural and Fentanyl, Bupivacaine epidural after spinal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 18 to 75 years old; patients undergoing Spondylolisthesis surgery and Spinal fixation;American Society of Anesthesiologists (ASA) I, II, III
Exclusion criteria: If the Dural be damaged; Patient dissatisfaction
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan university of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193893345
Approval date
2014-05-12, 1393/02/22
Ethics committee reference number
1930075301
Health conditions studied
1
Description of health condition studied
Relevance analgesia and side effects with Fentanyl epidural and Fentanyl - Bupivacaine epidural after spinal surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
when patient were transferred to the section from recovery unit then every 6 hours to 24 hours
Method of measurement
Visual analogous score
2
Description
Hypotension
Timepoint
when patient were transferred to the section from recovery unit then every 6 hours to 24 hours
Method of measurement
mmHg, Saadat company
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1) For primary pain control Apotel 1 gram in 100 cc normal saline will be infused 20 minutes prior to the end of surgery, then repeat every 6 hours. . If VAS is more than 4 , we inject 1 mg intravenous of morphine .
Category
Treatment - Drugs
2
Description
Intervention 2) Surgeon put an epidural catheter in the L3-L4 epidural space at the end of operation. Epidural pump with 100 microgram Fentanyl added to 98 cc normal saline 3–5 ml/h after patient arrival to recovery unit will be infused. Primary pain control Apotel 1 gram in 100 cc normal saline, 20 minutes prior to the end of surgery will be infused for all of patients, and then repeat every 6 hours. If VAS is more than 4, we inject 1 mg intravenous of Morphine.
Category
Prevention
3
Description
Intervention3) The Surgeon put an epidural catheter in the L3-L4 epidural space at the end of operation. Epidural pump with 98 cc normal saline add to100 microgram Fentanyl and Bupivacaine 0.125 %( 24 ml Bupivacaine 0.5% add to 72 ml normal saline), 3–5 ml/h will be infused after patient arrival to recovery unit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Ali Ashraf
Street address
Parastar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Ali ashraf
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; alishraf@yahoo.fr
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Ali Ashraf
Position
Anesthesiologist, Assistant proffessor
Other areas of specialty/work
Street address
Poursina hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com;
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician, Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
nematihedieh@@gmail.com; arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)