Elbow Fracture Clinical Trial
Official title:
The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
The goal of this study is to compare different ways of treating pain after surgery. This
research study involves subjects who have a supracondylar elbow fracture and need surgery.
This type of fracture occurs when the humerus (upper arm bone) is broken just above the
elbow. Like any other surgery, you can expect that you will feel pain in the hours or days
after the operation. Currently, despite the common occurrence of this surgery, there is not
a standard way to treat and or prevent any of the pain afterwards.
At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after
this surgery.
In this study, pain will be treated in one of the following ways:
1. with oral pain medication
2. with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of
bupivacaine (a "numbing" drug) or
3. with oral pain medicine and an intraarticular shot of ropivacaine (another "numbing"
drug). The shots will be given during surgery. Your participation will help us find out
which of these three pain control methods works the best.
The correct dosages of all drugs will be safely prescribed by the doctor on an individual
basis and all drugs will be used under the careful watch of your attending physician. All
the drugs used this study are approved by the FDA for use in adults but they are not
specifically approved for use in children. However, nearly 7 out of every 10 drugs approved
for adults are not specifically approved by the FDA for use in children. All drugs used in
this study will be used in a way that is considered to be safe and reasonable by the
Children's Hospital.
Purpose: In recent years, despite the lack of consistent evidence, the use of intraarticular
(into the joint)injections during ambulatory, orthopaedic surgery has become a popular
strategy for reducing post-operative pain. In this randomized, single center, prospective
study the investigators will evaluate the analgesic effectiveness of intraarticular
injections of local anesthesia during the closed reduction and percutaneous pinning (CRPP)
of supracondylar type elbow fractures (SCEFx) in children. In order to determine the
efficacy of intraarticular injections, perceived post-operative pain will be compared among
the three study groups receiving either a 0.25 % intraarticular injection of bupivacaine
(Group 1 ), a 0.20% intraarticular injection of ropivacaine (Group 2) or no intraarticular
injection (Control). All groups will receive the same post-operative oral pain medication of
oxycodone (0.1 to 0.15 mg/kg) with acetaminophen.
Primary Aim(s) : Compare the primary and secondary pain outcomes variables in each of the
three study groups.
- The primary pain outcome variables are defined as the following:
- Self-reported pain within 30-60 min. of arrival to the recovery room
- Self-reported pain at two hours post-operative
- The secondary pain outcome variables are defined as the following:
- Parent perception of post-operative pain (scores of modified version of Foster and
Varni's Total Quality of Pain Management Survey (TQPM) given in the first two
hours after surgery)
- Time t o first administration of oral pain medication
- Total dose and frequency of oral pain medication taken during first 72 hours
post-operative
- Dose (per kg) of local anesthetic received intra-operatively
- Total dosage of all intra-operative analgesics (in morphine equivalents)
- Pre-operative The Faces Pain Scale-Revised (FSP-R) score
Hypotheses for Primary Aims:
- There will not be a significant difference in any of the pain outcome variables amongst
Groups 1 and 2.
- There will be a statistically significant difference in each of the pain outcome
variables when comparing; Group 1 and Control as well as Group 2 and Control.
Secondary Aim I: Evaluate the overall effect gender, ethnicity, age, American Society of
Anesthesiologists (ASA) classification, fracture type and anesthesia time have on the pain
outcome variables in this study population:
Hypotheses for Secondary Aim I: The investigators expect that age, gender, ASA
classification, fracture type and anesthesia time will have a significant effect of on the
primary and secondary pain outcome variables in this study population as a whole.
- Participants aged 4-7 will be associated with more pain than participants aged 8-12
(increased selfreported pain scores, increased parent TQPM scores, decreased time to
first administration of oral pain medication, increased total dosage of oral pain
medication taken during first 72 hours post-operative, increased frequency of oral pain
medication taken during first 72 hours post-operative).
- Females will be associated with more pain than males (increased self-reported pain
scores, increased parent TQPM scores, decreased time to first administration of oral
pain medication, increased total dosage of oral pain medication taken during first 72
hours post-operative, increased frequency of oral pain medication taken during first 72
hours post-operative ) .
- An ASA classification of III will be associated with more pain than a classification of
I or II (increased self-reported pain scores, increased parent TQPM scores, decreased
time to first administration of oral pain medication, increased total dosage of oral
pain medication taken during first 72 hours post-operative, increased frequency of oral
pain medication taken during first 72 hours post-operative),
- A type III fracture type will be associated with more pain than a type I or II
(increased selfreported pain scores, increased parent TQPM scores, decreased time to
first administration of oral pain medication, increased total dosage of oral pain
medication taken during first 72 hours post-operative, increased frequency of oral pain
medication taken during first 72 hours post-operative).
- An increase in anesthesia time will be associated with more pain . (increased
self-reported pain scores, increased parent TQPM scores, decreased time to first
administration of oral pain medication, increased total dosage of oral pain medication
taken during first 72 hours post-operative, increased frequency of oral pain medication
taken during first 72 hours post-operative).
Secondary Aim II: Evaluate the overall effect that gender, ethnicity, age, ASA
classification (I, II or III),fracture type and anesthesia time have on the pain outcome
variables in each of the study groups (Compare 1, 2 and Control to study population as a
whole).
Hypotheses for Secondary Aim II: The investigators anticipate that there will be no group
difference in the effects that age, gender, ASA classification, fracture type or anesthesia
time have on the primary and secondary pain outcome variables.
Secondary Aim III: Compare Group 1 and Group 2 for a potential dose dependent relationship
between reported pain outcome variables and total dose of intraarticular injection.
Hypotheses for Secondary Aim III: In both groups, the investigators anticipate there will be
a non-significant association between an increased dose of local anesthetic and decreased
post-operative FSP-R scores. There will not be any difference in the significance of this
dose dependent relationship between Group I and Group 2.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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