Regional Blocks for Lateral Condyle Fractures
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|ClinicalTrials.gov Identifier: NCT03796572|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Fractures, Closed Humeral Fractures Pain||Drug: Ropivacaine Other: Puncture Wound and Dressing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blinded randomized control trial|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Randomized envelopes used to allocate treatment groups.|
|Official Title:||A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures|
|Actual Study Start Date :||September 16, 2019|
|Estimated Primary Completion Date :||January 7, 2024|
|Estimated Study Completion Date :||March 7, 2024|
Experimental: Infraclavicular Regional Block
This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved.
Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine
Sham Comparator: Puncture Wound
This group is given the same puncture wound and dressing given to the experimental group.
Other: Puncture Wound and Dressing
No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture
- Change in Wong-Baker FACES Pain Scale-Revised (FPSR) [ Time Frame: 24 hours, 48 hours, and 1 week post-operatively ]Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.
- Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire [ Time Frame: 1 week at first post-operative follow-up ]30 question questionnaire used to measure the quality of children's post-operative pain management in which parents and patients are asked multiple questions. Questions are partitioned into the following categories: "What were you told about the hurt or pain?", "How did the pain medicine make you feel?", "How long did the hurt or pain last?", "How much hurt or pain did you feel?", "How happy were you with the pain?", and "Tell us how we could get an A+ for taking the hurt or pain away." Specific questions were aimed at gaining information on the following topics: post-operative pain management including domains in pain experience, pain relief, adverse affects, and future analgesic uses. The majority of the questions are binary (yes or no) and there are a few questions that include mild (best), moderate, and severe (worst) option. There is no numerical output or subscales; every question is evaluated independently and not combined for summary scores.
- Pain Medication Logs (Amount Taken) [ Time Frame: Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days. ]Self report take home medications logs recording time, type, and dosage of medication to record total amount of medication (mg) taken by patient.
- Pain Medication Logs (Side Effects) [ Time Frame: Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days. ]Self report take home medications logs recording associated side effects of medication taken.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796572
|Contact: Samantha C Bauer, MS||2137426537 ext 6537||SBauer@mednet.ucla.edu|
|Contact: Sierra M Pinal, BS||2137421057 ext firstname.lastname@example.org|
|United States, California|
|Orthopaedic Institute for Children||Recruiting|
|Los Angeles, California, United States, 90007|
|Contact: Mauricio Silva, MD 213-742-1369 email@example.com|
|Contact: Samantha C Bauer, MS 2137426537 ext 6537 SBauer@mednet.ucla.edu|
|Principal Investigator: Mauricio Silva, MD|