Comparison of postoperative analgesia following i.v. patient-controlled analgesia (PCA) versus femoral catheter PCA after Arthroscopic Anterior Cruciate Ligamentum (ACL) repair
In this randomized clinical trial, 70 Patients candidated for arthroscopic anterior cruciate ligamentum (ACL) repair surgery were enrolled in two groups, intravenous PCA (PCIA) and regional PCA (PCRA). Analgesic solution in the PCIA group was morphine %0.2, and in the PCRA group after performance of the femoral nerve block with catheter insertion in the recovery room, was bupivacaine %0.1. All the pumps were 5 ml/h constant flow rate. The patients were evaluated for postoperative pain by visual analogue scale (VAS) and side effects in the 1, 8, 16, 24, 32 and 40 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901182366N2
Registration date:2010-04-20, 1389/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-20, 1389/01/31
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences (IUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
imani.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2007-06-22, 1386/04/01
Expected recruitment end date
2008-08-21, 1387/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative analgesia following i.v. patient-controlled analgesia (PCA) versus femoral catheter PCA after Arthroscopic Anterior Cruciate Ligamentum (ACL) repair
Public title
Comparison of postoperative analgesia following i.v. patient-controlled analgesia (PCA) versus femoral catheter PCA after Arthroscopic Anterior Cruciate Ligamentum (ACL) repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1) patient who candidated for ACL surgery,
2) aged 20-50 yrs,
3) ASA physical status I, II.
Exclusion Criteria:
1) presence of coexisting diseases (coagulative, seizure, cardiac, ...),
2) history of smoking, opioid and alchohol addiction,
3) allergy to morphine or local anesthetic,
4) patient refusal .
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Crossroads of Hemmat & Chamran Expressways
City
Tehran
Postal code
14496
Approval date
2007-06-10, 1386/03/20
Ethics committee reference number
4274
Health conditions studied
1
Description of health condition studied
Tear of meniscus, current
ICD-10 code
S83.2
ICD-10 code description
Tear of meniscus, current
2
Description of health condition studied
Opioids and related analgesics
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics
3
Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
4
Description of health condition studied
Pain in joint
ICD-10 code
M25.5
ICD-10 code description
Pain in joint
Primary outcomes
1
Description
postoperative analgesia
Timepoint
every 8 hrs
Method of measurement
Visual analoque scale
Secondary outcomes
1
Description
complications
Timepoint
every 8 hrs
Method of measurement
patient evaluation and observation
Intervention groups
1
Description
Intervention group: After postoperative femoral nerve block in the recovery room and catheter insertion, PCRA pump contain Bupivacaine %0.1 was connected to the femoral catheter
Category
Treatment - Other
2
Description
Control group: PCA contain morphie 0.2 mg/ml was connectd to iv line.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-Akram Hospital
Full name of responsible person
Farnad Imani
Street address
Department of Anesthesiology and Pain Medicine
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akbar Sharafi M.D. Vice chancellor for research
Street address
Crossroads of Hemmat & Chamran Expressways
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Chairman, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology & Pain Medicine, Rasool-Akram Hospital
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Rasool-Akram Hospital
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Chairman/ Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology & Pain Medicine, Rasool-Akram Hospital, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)