Effect of femoral block versus intravenous infusion pump on postoperative pain in patients underwent surgical repair of anterior cruciate ligament: a randomized clinical trial
Objectives: To assess the effect of femoral block versus intravenous infusion pump on postoperative pain in patients underwent surgical repair of anterior cruciate ligament.
Design: A randomized clinical trial.
Setting and conduct: All eligible patients with rapture of anterior cruciate ligament who will refer to the Beasat Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) rapture of anterior cruciate ligament; (b) age of 12 to 70 years.
Exclusion criteria: (a) sensitivity to local anesthesia; (b) unable to use infusion pump; (c) history of narcotic addiction; (d) chronic liver failure; (e) renal failure; (f) indication of repairing bilateral anterior cruciate ligament; (g) history of previous inguinal surgery; (h) tumor or enlarged inguinal lymph node; (i) femoral nerve neuropathy; (j) infection of the inguinal area.
Intervention: Femoral block at the inguinal area using Marcaine 25% 10 ml single dose at the end of surgery.
Control: Intravenous infusion pump using morphine 30 mg in 100 ml normal saline with the speed of 4 ml/min single dose at the end of surgery.
Primary outcome: Pain at the surgical site at zero time and then every 4 hours for 24 hours after surgery using VAS.
Secondary outcome: (a) patient’s satisfaction at zero time and at 12 and 24 hours after surgery using Likert scale; (b) nausea and vomiting at zero time and then every 4 hours for 24 hours after surgery by question.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402279014N27
Registration date:2014-03-09, 1392/12/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-09, 1392/12/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of femoral block versus intravenous infusion pump on postoperative pain in patients underwent surgical repair of anterior cruciate ligament: a randomized clinical trial
Public title
Effect of femoral block versus intravenous infusion pump on postoperative pain in patients underwent surgical repair of anterior cruciate ligament
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) rapture of anterior cruciate ligament; (b) age of 12 to 70 years.
Exclusion criteria: (a) sensitivity to local anesthesia; (b) unable to use infusion pump; (c) history of narcotic addiction; (d) chronic liver failure; (e) renal failure; (f) indication of repairing bilateral anterior cruciate ligament; (g) history of previous inguinal surgery; (h) tumor or enlarged inguinal lymph node; (i) femoral nerve neuropathy; (j) infection of the inguinal area.
Age
From 12 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control group using tossing coin.
Blinding: Since the intravenous infusion pump is out of the body and will be seen by both patients and the physician, hence, the study cannot be blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
D/P/16/35/9/3565
Health conditions studied
1
Description of health condition studied
Pain at surgical site at inguinal area
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
Pain at the surgical site
Timepoint
at zero time and then every 4 hours for 24 hours after surgery
Method of measurement
using VAS scale
Secondary outcomes
1
Description
patient’s satisfaction
Timepoint
at zero time and at 12 and 24 hours after surgery
Method of measurement
using Likert scale
2
Description
nausea and vomiting
Timepoint
at zero time and then every 4 hours for 24 hours after surgery
Method of measurement
by question
Intervention groups
1
Description
Femoral block at the inguinal area using Marcaine 25% 10 ml single dose at the end of surgery.
Category
Treatment - Drugs
2
Description
Intravenous infusion pump using morphine 30 mg in 100 ml normal saline with the speed of 4 ml/min single dose at the end of surgery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Dr Navid Hadadzadegan
Street address
Beasat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Beasat Hospital
Full name of responsible person
Dr Navid Hadadzadegan
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
00
Fax
Email
hadadzadegan1359@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Beasat Hospital
Full name of responsible person
Dr Pouran Hajian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beasat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 1341 6392
Fax
Email
hajian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)