Fractures, ClosedPhase 4NCT03796572
Regional Blocks for Lateral Condyle Fractures
A Phase 4 study testing Ropivacaine and Puncture Wound and Dressing in people with Fractures, Closed and Humeral Fractures, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to investigate the post-operative pain control in pediatric patients with closed lateral condyle fractures who undergo open reduction and percutaneous pinning. Patients will be randomized into one of two groups. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fractures, Closed, Humeral Fractures, Pain
- What is being tested?
- Ropivacaine and Puncture Wound and Dressing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 7 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Isolated lateral condyle humerus fracture
- Closed lateral condyle humerus fracture
- Weiss classification type II and III (>2mm displacement) lateral condyle fractures
- Fractures treated with open reduction percutaneous pinning requiring fixation
Who cannot join
- Open fractures
- Fractures with concomitant vascular or neurologic deficit
- Pathologic fractures
- Those presenting with concomitant injuries
- Swelling requiring post-operative hospitalization for monitoring
- Any known history of allergies to ropivacaine or oxycodone
- Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orthopaedic Institute for Children
Los Angeles, California, 90007
Mauricio Silva, MD, (213) 742-1369, msilva@mednet.ucla.edu
Samantha C Bauer, MS, 2137426537 ext. 6537, SBauer@mednet.ucla.edu
About this study
Official title: A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures
The purpose of this study is to investigate the post-operative pain control in pediatric patients with closed lateral condyle fractures who undergo open reduction and percutaneous pinning. Patients will be randomized into one of two groups. Group 1 will receive an infraclavicular nerve block to the affected extremity by a fellowship trained pediatric anesthesiologist prior to surgery. Group 2 will undergo the Orthopaedic Institute of Children's (OIC) standard preoperative protocol. Post-operative pain management will be the same for both groups per standard protocol. Pain level will be assessed post-operatively using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. All patients in both groups will receive standard oxycodone solution prescriptions post-operatively as per typical protocol. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery and 1st post-op visit). This study is being conducted in hopes of developing comprehensive pain management protocols to reduce opioid consumption after surgical fixations of displaced lateral condyle fractures if the study can show that patients are more satisfied and require less opioid medication when receiving preoperative regional anesthesia.
Read the detailed description
This is a double-blinded, randomized controlled trial evaluating the analgesic efficacy of infraclavicular regional blocks for postoperative pain control in patients following open reduction and percutaneous pinning for isolated closed lateral condyle fractures. Each patient will be evaluated initially at OIC's pediatric urgent care center and placed in a long arm splint with instructions to elevate the affected arm. Patients will not be discharged with any prescriptions for narcotic pain medication and will be instructed to take weight-based doses of acetaminophen and/or ibuprofen for pain control as needed.
All patients age 4-12 with isolated closed Weiss classification type II and III (>2mm displacement) lateral condyle fractures requiring fixation (e.g. satisfactory reduction not achieved with closed reduction and casting) will be approached for participation in the study. Demographic data (age, gender, weight, height, ethnicity, primary language spoken at home, insurance type) will be obtained through chart review on each included patient.
The exclusion criteria include open fractures, fractures with concomitant vascular or neurologic deficit, pathologic fractures, those presenting with concomitant injuries, swelling requiring post-operative hospitalization for monitoring, any known history of allergies to ropivacaine or oxycodone, and patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised. Informed consent will be obtained from all parents who wish to participate in the study, and assent will be obtained from patients when possible. If parents refuse participation in the study, the reason for refusal will be documented, and their child's care and post-operative protocol will be consistent with typical protocol at OIC.
All surgeries will be performed at the outpatient surgery center at OIC. Prior to surgery each patient will be randomized into one of two treatment groups. The group selected to undergo regional anesthesia will receive a single-stick ultrasound-guided infraclavicular nerve block to the affected extremity by a fellowship-trained pediatric anesthesiologist in the operating room using standard sterile technique. For each block ropivacaine 0.5% will be administered up to a max of 0.5 mL/kg until appropriate US-guided spread is achieved. Block duration and volume of ropivacaine used will be recorded, as will any immediate complications encountered (e.g. failed block). Participants randomized to the no regional anesthesia group will not receive any additional anesthetic prior to surgery and will undergo OIC's standard preoperative protocol. All patients in both groups will receive general anesthesia per standard protocol. All patients will undergo open reduction and percutaneous pinning using 2-3 pins placed laterally by two pediatric orthopedic surgeons (Dr. Mauricio Silva and Dr. Rachel Thompson). Participants will all be placed in posterior long arm splints thereafter and made non-weight bearing in that extremity. The patients will be transferred to OIC's post-anesthesia care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed before discharge home. Nursing staff will record the amount of pain medication provided in the PACU, as well as the pre-discharge pain scores, as is typical post-operative protocol. Prior to discharge a prescription for oxycodone solution 0.1 mg/kg PO q4-6 hours as needed will be given to all participants in both groups with instructions on medication administration and how to fill out the home medication log as per typical OIC post-operative protocol.
Post-operatively, the parents of each participant will be asked to use the Faces Pain Scale-Revised (FPS-R) to rate the child's level of pain at 24 hours and 48 hours after surgery. A research team member will call each participant's guardian at 24 and 48 hours post-operatively to collect these responses. Parents will further be asked to complete the modified Total Quality Pain Management Instrument (TQPM) regarding their level of satisfaction with surgery and post-operative pain control. Parents will be asked to report any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the medications. Parents will also be asked about any side effects (e.g. swelling, redness, hematoma, prolonged block) from the regional anesthesia. A take-home medication log will be utilized by the parents to record the type and amount of mediation given to each participant and to record any associated side effects.
- Conditions
- Fractures, Closed, Humeral Fractures, Pain
- Being tested
- Ropivacaine, Puncture Wound and Dressing
- Keywords
- lateral condyle, infraclavicular, regional block
- Medical subject headings
- Fractures, Closed, Humeral Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine
Puncture Wound and DressingOther
No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture
| Study group | Role | What they receive |
|---|---|---|
| Infraclavicular Regional Block | Experimental | This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved. Receives: Drug: Ropivacaine |
| Puncture Wound | Sham comparator | This group is given the same puncture wound and dressing given to the experimental group. Receives: Other: Puncture Wound and Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wong-Baker FACES Pain Scale-Revised (FPSR)
Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.
Measured: 24 hours, 48 hours, and 1 week post-operatively
Secondary outcomes (1)
Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire
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.
Measured: 1 week at first post-operative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start16 Sep 2019
- Primary completion7 Jan 2027 (estimated)
- Study completion7 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, ClosedStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio Silva, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796572
- Sponsor's protocol ID
- 18-001552
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures
- ClinicalTrials.gov ID
- NCT03796572
- Acronym / sponsor ID
- 18-001552
- Conditions
- Fractures, Closed, Humeral Fractures, Pain
- Keywords
- lateral condyle, infraclavicular, regional block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 7 Mar 2027 (estimated)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the post-operative pain control in pediatric patients with closed lateral condyle fractures who undergo open reduction and percutaneous pinning. Patients will be randomized into one of two groups. Group 1 will receive an infraclavicular nerve block to the affected extremity by a fellowship trained pediatric anesthesiologist prior to surgery. Group 2 will undergo the Orthopaedic Institute of Children's (OIC) standard preoperative protocol. Post-operative pain management will be the same for both groups per standard protocol. Pain level will be assessed post-operatively using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. All patients in both groups will receive standard oxycodone solution prescriptions post-operatively as per typical protocol. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery and 1st post-op visit). This study is being conducted in hopes of developing comprehensive pain management protocols to reduce opioid consumption after surgical fixations of displaced lateral condyle fractures if the study can show that patients are more satisfied and require less opioid medication when receiving preoperative regional anesthesia.
Detailed description
This is a double-blinded, randomized controlled trial evaluating the analgesic efficacy of infraclavicular regional blocks for postoperative pain control in patients following open reduction and percutaneous pinning for isolated closed lateral condyle fractures. Each patient will be evaluated initially at OIC's pediatric urgent care center and placed in a long arm splint with instructions to elevate the affected arm. Patients will not be discharged with any prescriptions for narcotic pain medication and will be instructed to take weight-based doses of acetaminophen and/or ibuprofen for pain control as needed.
All patients age 4-12 with isolated closed Weiss classification type II and III (>2mm displacement) lateral condyle fractures requiring fixation (e.g. satisfactory reduction not achieved with closed reduction and casting) will be approached for participation in the study. Demographic data (age, gender, weight, height, ethnicity, primary language spoken at home, insurance type) will be obtained through chart review on each included patient.
The exclusion criteria include open fractures, fractures with concomitant vascular or neurologic deficit, pathologic fractures, those presenting with concomitant injuries, swelling requiring post-operative hospitalization for monitoring, any known history of allergies to ropivacaine or oxycodone, and patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised. Informed consent will be obtained from all parents who wish to participate in the study, and assent will be obtained from patients when possible. If parents refuse participation in the study, the reason for refusal will be documented, and their child's care and post-operative protocol will be consistent with typical protocol at OIC.
All surgeries will be performed at the outpatient surgery center at OIC. Prior to surgery each patient will be randomized into one of two treatment groups. The group selected to undergo regional anesthesia will receive a single-stick ultrasound-guided infraclavicular nerve block to the affected extremity by a fellowship-trained pediatric anesthesiologist in the operating room using standard sterile technique. For each block ropivacaine 0.5% will be administered up to a max of 0.5 mL/kg until appropriate US-guided spread is achieved. Block duration and volume of ropivacaine used will be recorded, as will any immediate complications encountered (e.g. failed block). Participants randomized to the no regional anesthesia group will not receive any additional anesthetic prior to surgery and will undergo OIC's standard preoperative protocol. All patients in both groups will receive general anesthesia per standard protocol. All patients will undergo open reduction and percutaneous pinning using 2-3 pins placed laterally by two pediatric orthopedic surgeons (Dr. Mauricio Silva and Dr. Rachel Thompson). Participants will all be placed in posterior long arm splints thereafter and made non-weight bearing in that extremity. The patients will be transferred to OIC's post-anesthesia care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed before discharge home. Nursing staff will record the amount of pain medication provided in the PACU, as well as the pre-discharge pain scores, as is typical post-operative protocol. Prior to discharge a prescription for oxycodone solution 0.1 mg/kg PO q4-6 hours as needed will be given to all participants in both groups with instructions on medication administration and how to fill out the home medication log as per typical OIC post-operative protocol.
Post-operatively, the parents of each participant will be asked to use the Faces Pain Scale-Revised (FPS-R) to rate the child's level of pain at 24 hours and 48 hours after surgery. A research team member will call each participant's guardian at 24 and 48 hours post-operatively to collect these responses. Parents will further be asked to complete the modified Total Quality Pain Management Instrument (TQPM) regarding their level of satisfaction with surgery and post-operative pain control. Parents will be asked to report any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the medications. Parents will also be asked about any side effects (e.g. swelling, redness, hematoma, prolonged block) from the regional anesthesia. A take-home medication log will be utilized by the parents to record the type and amount of mediation given to each participant and to record any associated side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Infraclavicular Regional Block | Experimental | Drug: RopivacaineThis group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved. |
| Puncture Wound | Sham comparator | Other: Puncture Wound and DressingThis group is given the same puncture wound and dressing given to the experimental group. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Isolated lateral condyle humerus fracture
- Closed lateral condyle humerus fracture
- Weiss classification type II and III (>2mm displacement) lateral condyle fractures
- Fractures treated with open reduction percutaneous pinning requiring fixation
Key exclusion criteria (7 listed)
- Open fractures
- Fractures with concomitant vascular or neurologic deficit
- Pathologic fractures
- Those presenting with concomitant injuries
- Swelling requiring post-operative hospitalization for monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineRegional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine | Drug | Infraclavicular Regional Block |
| Puncture Wound and DressingNo regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture | Other | Puncture Wound |
Primary outcome
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.
1 secondary outcome
Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire
Time frame: 1 week at first post-operative follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Puncture Wound and Dressing in people with Fractures, Closed and Humeral Fractures, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Han, BA ((213) 742-1074, LLHan@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wong-Baker FACES Pain Scale-Revised (FPSR) (time frame: 24 hours, 48 hours, and 1 week post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.