Effectiveness of adding Ketamine to Ropivacaine in continues femoral nerve block for postoperative pain control in anterior cruciate ligament reconstruction surgeries
Continues femoral nerve block is one of common ways to relieve pain after reconstruction surgery of anterior cruciate ligament of knee. We decided to decrease Ropivacaine concentration and instead adding Ketamine -an NMDA receptor antagonist- to see reasonable analgesia with reduced motor block. Setting: Orthopedic surgery ward of Prophet Muhammad hospital in Tehran University of medical sciences. Study population: patients who are candidate for elective anterior cruciate ligament reconstruction surgery during 2010 and 2011. Sampling: simple sequential sampling. Inclusion Criteria: 1) Age 15 to 60 years; 2) ASA I & II. Exclusion Criteria: 1) A history of drug misuse 2) Allergy to Ketamine and Ropivacaine. Primary objectives: 1) Determination of VAS score by adding Ketamine (1 mg/kg) to Ropivacaine 0.125% in PCRA pump using continuous femoral nerve block; 2) Determination of Quadriceps motor block quality by adding ketamine (1 mg/kg) to ropivacaine 0.125% in PCRA pump using continuous femoral nerve block.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111278221N1
Registration date:2013-02-23, 1391/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Kayvan Niknam
Name of organization / entity
Tehran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4481 9954
Email address
kayvanniknam@irimc.org
Recruitment status
Recruitment complete
Funding source
Govermental
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of adding Ketamine to Ropivacaine in continues femoral nerve block for postoperative pain control in anterior cruciate ligament reconstruction surgeries
Public title
Efficacy of adding Ketamine to Ropivacaine in continues femoral nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1) Age 15 to 60 years; 2) ASA I & II; 3) candidates for elective knee surgery; 4) Written consent. Exclusion Criteria: 1) A history of drug misuse; 2) Allergy to Ketamine and Ropivacaine; 3) Alcohol and drugs abuse; 4) Pregnancy and breast feeding; 5) Refusing patients studied; 6) Infection in block area; 7) Any neuropathy; 8) Diabetes; 9) Cardiovascular disease; 10) Hypertension; 11) Renal insufficiencies; 12) Liver failure.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of medical sciences
Street address
Hemat highway
City
Tehran
Postal code
Approval date
2010-06-12, 1389/03/22
Ethics committee reference number
42116
Health conditions studied
1
Description of health condition studied
Ant cruciate ligament strain
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
Motor block
Timepoint
48 hours after surgery
Method of measurement
based on Quadriceps muscle weakness
2
Description
Pain
Timepoint
48 hours after surgery
Method of measurement
based on VAS
Secondary outcomes
1
Description
Opioid requirment
Timepoint
48 hours after surgery
Method of measurement
Based on miligram of opioid required
Intervention groups
1
Description
Femoral block with 0.3 cc/kg Ropivacaine %0.2 performed and femoral catheter for continues infusion of medication with pump inserted and 100 cc Ropivacaine %0.2 was placed in infusion pump; infusion rate was 5cc/hour.
Category
Treatment - Drugs
2
Description
Femoral block with 0.3 cc/kg Ropivacaine %0.2 performed and femoral catheter for continues infusion of medication with pump inserted and 100cc Ropivacaine %0.125 with Ketamine 1mg/kg was placed in infusion pump; infusion rate was 5cc/hour. Pumps were refilled if they were finished.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Dr. Seyed Hamidreza Faiz
Street address
Rasoul Akram hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-chancellor of research, Dr. Akbar fotoohi
Street address
Vice-chancellor of research of Tehran University of medical sciences, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran university ofmedical sciences
Full name of responsible person
Dr. Seyed Hamidreza Faiz
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasoul Akram hospital
City
Tehran
Postal code
Phone
+98 21 64351
Fax
Email
hrfaiz@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Seyed Hamidreza Faiz
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasoul Akram hospital
City
Tehran
Postal code
Phone
+98 21 8805 2256
Fax
Email
hrfaiz@hotmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)