One of the issues of concern to anesthesiologists is to control pain after surgery. This is important especially in orthopedic surgery. One of the appropriate methods to pain control is Biers block local anesthesia. In the course of time, various drugs were applied for this purpose such as Lidocaine.
Ketorolac is the only venous NSAID available in Iran which has FDA approval. This drug has been used in some traumatic surgeries for nerve block but with different results. This study is to evaluate the efficacy of Ketoroloc to control pain in patients undergoing surgeries due to fractures of forearm. Patients are categorized to a control group for whom nerve block in done with Lidocain and treatment group undergoing nerve block with Lidocain and Ketorolac. Onset and duration of analgesia will be compared between the two groups. Pain will be measured on the basis of “Numeric Pain Intensity Scale” in specific intervals and each patients will be given a score to be use in comparison between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042115587N5
Registration date:2014-07-05, 1393/04/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-05, 1393/04/14
Registrant information
Name
Nasrin Naseri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4263
Email address
grc@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Ketorolac as an adjunct to the Bier Block to control post operative pain following traumatic forearm surgery
Public title
Efficacy of ketorolac as an adjunct to the Bier Block to control post operative pain following traumatic forearm surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria of the study:
15> age> 60; Patients who undergo orthopedic surgery because of traumatic forearm fracture; Duration of surgery less than 90 minutes.
Exclusion criteria:
History of chronic analgesics consumption, for example Acetaminophen; History of drug abuse; Any signs of upper limb infection; Upper limb vascular disease; History of the severe psychiatric disease; Allergy to lidocaine or Ktorolac; Pregnancy; Renal Diseases
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Shiraz University of Medical Siences
Street address
Shiraz University of Medical Siences, Shiraz, Iran
City
Shiraz
Postal code
-
Approval date
2013-09-07, 1392/06/16
Ethics committee reference number
90-01-01-4203
Health conditions studied
1
Description of health condition studied
fracture of forearm
ICD-10 code
S52
ICD-10 code description
fracture of forearm
Primary outcomes
1
Description
The pain score in each group
Timepoint
-Every 15 min in the first hour then every 2 hr in the first day
Method of measurement
Numeric pain intensity scale (VAS Scoring system)
Secondary outcomes
1
Description
Narcotic consumption in the first 24 hours
Timepoint
24 hours after surgery.
Method of measurement
mg
Intervention groups
1
Description
Intervention group: Ketoroloc and Lidocain will be injected.