Aim: To compare the analgesic efficacy of combined lidocaine/dexamethasone and
lidocaine /fentanyl mixture following the operation of forearm fracture under axillary block. Materials and Methods: This is a clinical trial on 78 patients with forearm fracture that randomly divided into three groups. The axillary block was performed in the three groups by using lidocaine 40 ml and dH2O 2 ml (L Group), lidocaine 40 ml and dexamethasone 2 ml(LD group), and lidocaine 40 ml and fentanyl 2 ml( F group)., Duration of sensory and motor block, pain (using VAS) and the total analgesic dose administered during 6 hrs after the surgery were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120711687N1
Registration date:2013-07-22, 1392/04/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-22, 1392/04/31
Registrant information
Name
Mahyar Seddighi
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1334 4507
Email address
msedighi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Po. Box: 34185-745
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Postoperative Pain Management in Forearm Fracture with Lidocaine/Dexamethasone and Lidacaine/ Fentanyl through Axillary Block Technique
Public title
Comparison the analgesic efficacy of Lidocaine/Dexamethasone and Lidacaine/ Fentanyl in Forearm Fracture through Axillary Block
Purpose
Treatment
Inclusion/Exclusion criteria
Following inclusion criteria were considered: (a) Elective nature of surgery, presence of forearm fracture (b) Performance of surgery at Rajaei Hospital (c) Absence of underlying diseases such as coagulopathy, peripheral vascular diseases, and neuropathy (d) Patient’s full agreement on performing axillary anesthesia (e) Lack of any history of allergy to local anesthetics (f) Lack of treatment with palliative drugs and those affecting the CNS (g)Non-addict, and (h) Suitability of patients to be placed (classified) in ASA I&II classes. Also, the exclusion criteria employed were (a) operation duration of more than 90 min and b) the appearance of pain during the surgery
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar Blvd., Po. Box: 34185-745
City
Qazvin
Postal code
Approval date
2012-03-06, 1390/12/16
Ethics committee reference number
28/20/6579
Health conditions studied
1
Description of health condition studied
Analgesia following the operation of forearm fracture
ICD-10 code
S52.0, S52
ICD-10 code description
Fracture of upper end of ulna Incl.: Coronoid process Elbow, NOS, Monteggia fracture-dislocation Olecranon process Proximal end. Fracture of upper end of radius Incl.: Head Neck Proximal end. Fracture of shaft of ulna. Fracture of shaft of radius. Fract
Primary outcomes
1
Description
Total analgesic dose administered during 6 hrs after the surgery
Timepoint
During 6 hrs after the surgery
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Duration of sensory block
Timepoint
The time interval between the time of loss of pain sensation at forearm to reappearance of paresthesia
Method of measurement
Pin-prick test
2
Description
Time of duration of motor block
Timepoint
the time interval between the time of loss of pain sensation at forearm to complete recovery of motor function.