1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of continuous infusion of bupivacaine through intra-incisional catheter with control group for postoperative pain relieve in patients with intertrochanteric fracture

Protocol summary

Study aim
Comparison of the effect of continuous infusion of bupivacaine through intra-incisional catheter with control group for postoperative pain relieve in patients with intertrochanteric fracture
Design
Parallel Randomized Controlled Clinical Trial
Settings and conduct
At the end of the operation in the intervention group, an intra-incisional catheter will be placed under the fascial layer by surgeon, and after injection of 30 ml 0.25% bupivacaine it will be attached to an elastomeric pump containing 0.25% bupivacaine running 6 ml per hour. In control group no catheter will be placed. In both groups, an IV PCA morphine (0.5 mg/ml) pump will be run by the following setup: 2 ml bolus dose, 7 minutes lockout interval, no background infusion
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients who scheduled to undergo hip nailing surgery and can tolerate surgery under spinal anesthesia, ASA I-II, 50-85 years of age. Exclusion Criteria: Uncontrolled seizure, Local infection, coagulopathy, thrombocytopenia, history of hepatic and renal functional impairment, narcotic addiction, allergy to drugs which are going to be used in this study, history of psychosomatic pain, psychiatric diseases, Diabetic neuropathy, 2nd and 3rd degree A-V block.
Intervention groups
In intervention group intra-incisional catheter will be placed for continuous bupivacaine infusion. Patients in both groups will be attached to IV morphine PCA pumps for better pain relieve.
Main outcome variables
Pain intensity during the first postoperative day; total morphine administered during the first postoperative day

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100127003213N8
Registration date: 2020-03-16, 1398/12/26
Registration timing: registered_while_recruiting

Last update: 2020-03-16, 1398/12/26
Update count: 0
Registration date
2020-03-16, 1398/12/26
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
2019-03-21, 1398/01/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of continuous infusion of bupivacaine through intra-incisional catheter with control group for postoperative pain relieve in patients with intertrochanteric fracture
Public title
Effect of intraincisional bupivacaine infusion in intertrochanteric fracture
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who scheduled to undergo hip nailing surgery and can tolerate surgery under spinal anesthesia American Society of Anesthesiologists (ASA) I-II 50-85 years of age
Exclusion criteria:
Uncontrolled seizure Local infection Coagulopathy Thrombocytopenia History of hepatic and renal function impairment narcotic addiction Allergy to drugs which are going to be used in this study History of Psychosomatic pain Psychiatric diseases Diabetic neuropathy 2nd and 3rd degree A-V block
Age
From 50 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into intervention and control groups by block randomization using randomization.com website. This will randomly generate a sequence of 12 blocks, 4 patients in each. The name of the patients' group will be concealed in separate envelops which are identified by consecutive numbers related to the patient's entrance to the study.
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
2019-04-27, 1398/02/07
Ethics committee reference number
IR.SUMS.MED.REC.1398.099

Health conditions studied

1

Description of health condition studied
Femur fracture
ICD-10 code
S72.14
ICD-10 code description
Intertrochanteric fracture of femur

Primary outcomes

1

Description
Pain intensity
Timepoint
Every 15 minutes after surgery (15, 30, 45, 60 minutes) in recovery room, and every 2 hours after transfer to ward .
Method of measurement
Numerical Rating Scale of pain

2

Description
total morphine administration
Timepoint
total dose during the first postoperative 24 hours
Method of measurement
dose summation reported in milligrams

Secondary outcomes

1

Description
Patient’s global satisfaction
Timepoint
Discharge from the ward
Method of measurement
َA 5-point Likert scale: completely satisfied (= 5), partially satisfied (= 4), neutral (= 3), partially dissatisfied (= 2) and completely dissatisfied (= 1)

2

Description
Ease of ambulation
Timepoint
During admission
Method of measurement
Cumulated Ambulation Score

3

Description
Time to first request for analgesia
Timepoint
Time to first request, measured from termination of the procedure and recovery room entry
Method of measurement
minute

4

Description
Drug side effects (nausea & vomiting, respiratory depression, urinary retention, drowsiness, pruritus, hypotension, tinnitus)
Timepoint
Every four hours for 24 hours
Method of measurement
Occurrence frequency

Intervention groups

1

Description
Interventions group 1:At the end of the surgery an intra-incisional catheter (Infiltralong 600, PAJUNK, Geisingen, Germany) will be placed subfascially which will be connected to a 100 mL elastomeric pump, contained 0.25% bupivacaine by the rate of 6 ml per hour, after a 30 mL bolus dose of 0.25% bupivacaine (Bupivacaїne® Mylan, 100 mg/20 ml vial, Delpharm, France). The intra-incisional catheter will be disconnected after 36 hours.
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. infusing morphine, intravenously.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Sanaz Abbasi
Street address
Chamran Hospital, Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
1564471948
Phone
+98 71 3624 0101
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 Yones 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
Sanaz Abbasi
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sanaz_med65@yahoo.com

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
Email
arashfarbood@yahoo.com

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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is against our policies.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...