Comparison the effect of continuous injection of bupivacaine via intra incisional catheter versus PCA morphine pump on reduction of postoperative pain intensity in thoracic and lumbar spine fixation surgury
Comparison the effect of continuous injection of bupivacaine via intra incisional catheter application versus PCA morphine pump on reduction of postoperative pain intensity in thoracic and lumbar spinal fixation surgery
Design
Not blinded Randomized Clinical Trial
Settings and conduct
No blinding was performed in this study.To control postoperative pain in patients undergoing thoracic spine fixation surgeries in Chamran hospital, Shiraz, the surgeon puts a Intra incisional catheter for infusion of bupivacaine 6 ml / h until 24 h postoperatively and in control surgeon does not insert a multi-pore catheter in the fascia .
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who are candidate for surgical fixation of the thoracic and lumbar spine ,the age range-40 years (ASA1or2) ,The mental ability to collaborate in the study.
Exclusion criteria: Uncontrolled seizure, Depression, Localized surgical site infection, Rupture and repair of dura, Severe coagulation disorder, drug abuse or dependence, Drug Allergy, Patients with psycho-somatic pains
Intervention groups
Intervention group: surgeon puts a Intra incisional catheter at end of surgery ,which is connected to an elastomeric pump and infusion of bupivacaine (0.25% Bupivacaine, Mylan, A.S.A., France)will begin.
after bolus injection of 30 ml of bupivacaine 0.25% , 6 ml / h will begin until 24 h postoperatively.
Control group: The surgeon dose not put a Intra incisional catheter but intravenous morphine (Aburaihan Pharmaceutical Co.Iran) will be done with intravenous infusion pump until 24 h postoperatively.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003213N7
Registration date:2019-11-07, 1398/08/16
Registration timing:prospective
Last update:2019-11-07, 1398/08/16
Update count:0
Registration date
2019-11-07, 1398/08/16
Registrant information
Name
Arash Farbood
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
farboda@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of continuous injection of bupivacaine via intra incisional catheter versus PCA morphine pump on reduction of postoperative pain intensity in thoracic and lumbar spine fixation surgury
Public title
The effect of continuous infusion of bupivacaine via intra incisional catheter on reduction of pain intensity after surgery in spinal fixation surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for surgical fixation of the thoracic and lumbar spine (TLIF)
The age range is 75-40 years
(ASA = 1 or 2)
The mental ability to collaborate in the study
Exclusion criteria:
Uncontrolled seizure
Depression
Localized surgical site infection
Rupture and repair of dura,
Severe coagulation disorder
Abuse and drug dependence
Drug Allergy
Patients with psycho-somatic pains
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization:Patients will be randomized based on the randomization chart which is derived from from Randomization.org.
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 Shiraz University of Medical Sciences
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.SUMS.MED.REC.1396.125
Health conditions studied
1
Description of health condition studied
Spinal surgery
ICD-10 code
M43.25
ICD-10 code description
Fusion of spine, thoracolumbar region
Primary outcomes
1
Description
Pain
Timepoint
If the patient is consciousness: every 15 minutes (15-30-45-60 minute intervals) pain will be assessed in the recovery room.During the first 6 hours, every hour, at the second 6 hours every 2 hours and at the 12 hours later every 4 hours, pain will be assessed in the ward.
Method of measurement
Numeric Rating Scale (NRS)
Secondary outcomes
1
Description
First analgesic requirement based on minutes of the patient's presence in recovery room and ward
Timepoint
First analgesic requirement (based on minutes) after the patient's presence in recovery room every 15 minutes for an hour, and then in the ward every hour for 6 hours and then every 2 hours to 12 hours and then every 4 hours to 24 hours post operation.
Method of measurement
Observation
2
Description
Total morphine consumption
Timepoint
Total morphine consumption during postoperative first 24 h
Method of measurement
Observation
Intervention groups
1
Description
Intervention group:The surgeon puts a Intra incisional catheter(Infiltralong manufacturing company. Pajunk of Germany) before closing the surgical wound in the basement of the fascia.After insertion of the catheter , the catheter will be connected to an elastomeric pump and after injection of bolus dose(30 ml Bupivacaine 0.25%)(Bupivacaine,Mylan,A.S.A, France) infusion of bupivacaine 0.25% with rate 6 ml per hour until 24 h will begin.
Category
Prevention
2
Description
control group:The surgeon does not insert a Intra incisional catheter(Infiltralong manufacturing company. Pajunk of Germany)before the surgical wound is placed under the fascia layer.After the bolus injection of 2 ml of morphine sulfate( Aburaihan Pharmaceutical Co. Iran,) the pump settings are as follows:20 ml of morphine sulfate at a concentration of 0.5 mg / ml in normal saline solution infused with infusion pump .Minimum injection interval: 7 minutes, maximal injection every 4 hours: 40 ml, and continued for 24 hours.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital, Shiraz
Full name of responsible person
Vahid Parvin
Street address
Shahid Chamran Hospital, Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 71 3624 0101
Fax
Email
chamranhosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Parvin
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7156948623
Phone
+98 71 3647 4270
Fax
Email
v.parvin90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Farbood
Position
Anesthesiologist/Pain Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 36474270
Fax
Email
arashfarbood@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Arash Farbood
Position
Anesthesiologist/Pain Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 36474270
Email
arashfarbood@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available