The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

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.

Inclusion criteria

• ASA class I, II or III
• Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
• Patients able to understand and report their pain with the Faces Pain Scale Revised

Exclusion criteria

• Medical contraindications to analgesic therapy.
• Known allergy or sensitivity to analgesic agent.
• Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
• Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
• Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
• Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
• Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
• For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
• Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
• Known drug allergy to oxycodone and or acetaminophen.
• Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
• Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).