Pediatric Extremity FractureNCT02236130
Peripheral Nerve Blocks in Pediatric Orthopedic Patients
A study testing Regional block, General Anesthesia and Local Anesthetic Ropivacaine in people with Pediatric Extremity Fracture and Pediatric Extremity Soft Tissue Injury, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Context: Single shot peripheral nerve blocks have limited duration of action depending on the local anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need oral analgesics at home once the block wears off to control the pain. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Extremity Fracture, Pediatric Extremity Soft Tissue Injury
- What is being tested?
- Regional block, General Anesthesia and Local Anesthetic Ropivacaine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic surgery with moderate to severe postoperative pain.
- Surgery of moderate duration (<2hr)
- Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)
- ASA classification 1 or 2
- Parents able to understand follow up instructions and are able to reach at home by phone
Who cannot join
- Known allergy to local anesthetics
- Preexisting neuropathy with sensory or motor deficits
- Skin infection at site of needle placement
- Parents refusal for peripheral nerve blocks
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Peripheral Nerve Blocks in Pediatric Orthopedic Patients: Are There Any Post Recovery Benefits?
Context:
Single shot peripheral nerve blocks have limited duration of action depending on the local anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need oral analgesics at home once the block wears off to control the pain.
Read more
Objectives:
Primary Objective
To determine if peripheral nerve blocks have any advantage in terms of decreasing oral analgesic requirements in the post operative period even after the effects of the block have worn off
Secondary Objective
To determine if inclusion of single shot regional technique improves patient/family satisfaction with post operative pain management .
Study Design:
Prospective randomized single blinded study.
Inclusion Criteria
- Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic surgery with moderate to severe postoperative pain.
- Surgery of moderate duration (<2hr)
- Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)
- American Society of Anesthesiologists (ASA) classification 1 or 2
- Parents able to understand follow up instructions and are able to reach at home by phone
Exclusion Criteria
- Known allergy to local anesthetics
- Preexisting neuropathy with sensory or motor deficits
- Skin infection at site of needle placement
- Parents refusal for peripheral nerve blocks
Read the detailed description
80 children between the ages of 6yr and 17 yrs. scheduled for ambulatory peripheral orthopedic procedures in the operating rooms of Batson Children's Hospital will be enrolled in the study. Written informed consent will be obtained from the parents or legal guardian and assent will be obtained from patients when possible.
Once enrolled in the study, patients will be randomly assigned to one of two groups General anesthesia only (GA group) and General Anesthesia combined with regional anesthesia (RA group). Once the patients are brought to the operating room standard ASA monitors will be applied. After mask induction with O2/Nitrous oxide(N2O)/Sevoflurane(Sevo), a peripheral intravenous line will be inserted and secured. Additional IV medication propofol 2-3mg/kg will be given prior to insertion of appropriate size laryngeal mask airway (LMA). Patients in GA group will undergo the procedure under general anesthesia with Sevo/O2. Patients in the RA group will receive a peripheral nerve block appropriate for the procedure after induction of general anesthesia with O2/N2O/Sevo. The attending anesthesiologists will perform the nerve block under ultrasound guidance (Sonosite machine with high frequency probe) using 22G stimulating needle under aseptic precautions. 0.5% ropivacaine up to a total dose of 3mg/kg will be used for the block.
Anesthesia is maintained in both groups with O2/Sevo titrated to minimum alveolar concentration (MAC of) 1.5 . After surgical incision, doses of 0.05mg/kg morphine is given IV every 5 min as needed titrated to HR and BP within 10% change from baseline.
Additional IV morphine at the dose of 0.05mg/kg will be given every 10 minutes in the recovery room (PACU) as needed for pain ( Visual Analog score -VAS score >4). Total morphine consumption, length of recovery room stay and side effects such as nausea or vomiting will be recorded in the PACU.
The patients in the study will be given the following
- A prescription for oral analgesics (lortab: hydrocodone 5mg with acetaminophen 325mg).
- A handout about the nerve block and post op care (for patients in RA group)
- A handout depicting the visual analog scale
- Data sheet with date, time, pain scale and pain meds , satisfaction scale, documentation of side effects along with a stamped return envelope.
The parents will be educated about assessing pain and visual analog scale score. The parents will be instructed to give one or two pills depending on the weight (one pill for weight <50kg and 2 pills for weight >50kg)every 4-6 hrs. as needed for pain (VAS score more than 2).
The patients will be followed by phone by research nurse blinded to the group on postoperative day 2 and day 8. They will be asked about the total use of analgesics at the end of day 2 (first 48hrs) and day 7. Family satisfaction on a scale of 1 to10, Incidence of other side effects such as nausea, vomiting, sleep disturbance, feeding difficulty and prolonged numbness or motor block will also be collected.
The parents will also be requested to return the data sheet in the stamped return envelope to the research team.
- Being tested
- Regional block, General Anesthesia, Local Anesthetic Ropivacaine, Opioids Morphine, Oral pain medication Acetaminophen with Hydrocodone
- Keywords
- pediatric regional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional blockProcedure or surgery
Single shot peripheral nerve block
General AnesthesiaProcedure or surgery
General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic RopivacaineDrug
0.5% Ropivacaine
Opioids MorphineDrug
Morphine
Oral pain medication Acetaminophen with HydrocodoneDrug
Acetaminophen with Hydrocodone
| Study group | Role | What they receive |
|---|---|---|
| General | Active comparator | General Anesthesia only Receives: Procedure: General Anesthesia; Drug: Opioids Morphine; Drug: Oral pain medication Acetaminophen with Hydrocodone |
| Regional | Experimental | General Anesthesia combined with regional block Receives: Procedure: Regional block; Procedure: General Anesthesia; Drug: Local Anesthetic Ropivacaine; Drug: Opioids Morphine; Drug: Oral pain medication Acetaminophen with Hydrocodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Hydrocodone Dose (mg/kg)
Measured: day 2 and day 8 after the surgery
Secondary outcomes (1)
Patient/Family Satisfaction With Pain Management
Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.
Measured: one week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionOct 2015
Why it stopped: Poor response rate on follow up of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pediatric Extremity FractureStudies of the same condition, open and under way.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhankumar Sathyamoorthy, University of Mississippi Medical Center
- Investigators
- madhankumar sathyamoorthy, MBBS, MS, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236130
- Sponsor's protocol ID
- 2014-0027
- Status last verified
- Dec 2016
- First submitted
- 25 Aug 2014
- Last updated
- 13 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
PubMed 22786464Segerdahl M, Warren-Stomberg M, Rawal N, Brattwall M, Jakobsson J. Children in day surgery: clinical practice and routines. The results from a nation-wide survey. Acta Anaesthesiol Scand. 2008 Jul;52(6):821-8. doi: 10.1111/j.1399-6576.2008.01669.x. Epub 2008 May 21.
PubMed 18498436Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11.
PubMed 24330523Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.
PubMed 24407716Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available.
PubMed 21895855Polaner DM, Martin LD; PRAN Investigators. Quality assurance and improvement: the Pediatric Regional Anesthesia Network. Paediatr Anaesth. 2012 Jan;22(1):115-9. doi: 10.1111/j.1460-9592.2011.03708.x. Epub 2011 Sep 27.
PubMed 21951324Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.
PubMed 21199114
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Blocks in Pediatric Orthopedic Patients: Are There Any Post Recovery Benefits?
- ClinicalTrials.gov ID
- NCT02236130
- Acronym / sponsor ID
- 2014-0027
- Keywords
- pediatric regional
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor response rate on follow up of patients
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Posted 3 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Context:
Single shot peripheral nerve blocks have limited duration of action depending on the local anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need oral analgesics at home once the block wears off to control the pain.
Objectives:
Primary Objective
To determine if peripheral nerve blocks have any advantage in terms of decreasing oral analgesic requirements in the post operative period even after the effects of the block have worn off
Secondary Objective
To determine if inclusion of single shot regional technique improves patient/family satisfaction with post operative pain management .
Study Design:
Prospective randomized single blinded study.
Inclusion Criteria
- Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic surgery with moderate to severe postoperative pain.
- Surgery of moderate duration (<2hr)
- Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)
- American Society of Anesthesiologists (ASA) classification 1 or 2
- Parents able to understand follow up instructions and are able to reach at home by phone
Exclusion Criteria
- Known allergy to local anesthetics
- Preexisting neuropathy with sensory or motor deficits
- Skin infection at site of needle placement
- Parents refusal for peripheral nerve blocks
Detailed description
80 children between the ages of 6yr and 17 yrs. scheduled for ambulatory peripheral orthopedic procedures in the operating rooms of Batson Children's Hospital will be enrolled in the study. Written informed consent will be obtained from the parents or legal guardian and assent will be obtained from patients when possible.
Once enrolled in the study, patients will be randomly assigned to one of two groups General anesthesia only (GA group) and General Anesthesia combined with regional anesthesia (RA group). Once the patients are brought to the operating room standard ASA monitors will be applied. After mask induction with O2/Nitrous oxide(N2O)/Sevoflurane(Sevo), a peripheral intravenous line will be inserted and secured. Additional IV medication propofol 2-3mg/kg will be given prior to insertion of appropriate size laryngeal mask airway (LMA). Patients in GA group will undergo the procedure under general anesthesia with Sevo/O2. Patients in the RA group will receive a peripheral nerve block appropriate for the procedure after induction of general anesthesia with O2/N2O/Sevo. The attending anesthesiologists will perform the nerve block under ultrasound guidance (Sonosite machine with high frequency probe) using 22G stimulating needle under aseptic precautions. 0.5% ropivacaine up to a total dose of 3mg/kg will be used for the block.
Anesthesia is maintained in both groups with O2/Sevo titrated to minimum alveolar concentration (MAC of) 1.5 . After surgical incision, doses of 0.05mg/kg morphine is given IV every 5 min as needed titrated to HR and BP within 10% change from baseline.
Additional IV morphine at the dose of 0.05mg/kg will be given every 10 minutes in the recovery room (PACU) as needed for pain ( Visual Analog score -VAS score >4). Total morphine consumption, length of recovery room stay and side effects such as nausea or vomiting will be recorded in the PACU.
The patients in the study will be given the following
- A prescription for oral analgesics (lortab: hydrocodone 5mg with acetaminophen 325mg).
- A handout about the nerve block and post op care (for patients in RA group)
- A handout depicting the visual analog scale
- Data sheet with date, time, pain scale and pain meds , satisfaction scale, documentation of side effects along with a stamped return envelope.
The parents will be educated about assessing pain and visual analog scale score. The parents will be instructed to give one or two pills depending on the weight (one pill for weight <50kg and 2 pills for weight >50kg)every 4-6 hrs. as needed for pain (VAS score more than 2).
The patients will be followed by phone by research nurse blinded to the group on postoperative day 2 and day 8. They will be asked about the total use of analgesics at the end of day 2 (first 48hrs) and day 7. Family satisfaction on a scale of 1 to10, Incidence of other side effects such as nausea, vomiting, sleep disturbance, feeding difficulty and prolonged numbness or motor block will also be collected.
The parents will also be requested to return the data sheet in the stamped return envelope to the research team.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General | Active comparator | Procedure: General Anesthesia, Drug: Opioids Morphine, Drug: Oral pain medication Acetaminophen with HydrocodoneGeneral Anesthesia only |
| Regional | Experimental | Procedure: Regional block, Procedure: General Anesthesia, Drug: Local Anesthetic Ropivacaine, Drug: Opioids Morphine, Drug: Oral pain medication Acetaminophen with HydrocodoneGeneral Anesthesia combined with regional block |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic surgery with moderate to severe postoperative pain.
- Surgery of moderate duration (<2hr)
- Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)
- ASA classification 1 or 2
- Parents able to understand follow up instructions and are able to reach at home by phone
Key exclusion criteria (4 listed)
- Known allergy to local anesthetics
- Preexisting neuropathy with sensory or motor deficits
- Skin infection at site of needle placement
- Parents refusal for peripheral nerve blocks
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 |
|---|---|---|
| Regional blockSingle shot peripheral nerve block | Procedure or surgery | Regional |
| General AnesthesiaGeneral Anesthesia with O2/N2O/Sevoflurane | Procedure or surgery | General, Regional |
| Local Anesthetic Ropivacaine0.5% Ropivacaine | Drug | Regional |
| Opioids MorphineMorphine | Drug | General, Regional |
| Oral pain medication Acetaminophen with HydrocodoneAcetaminophen with Hydrocodone | Drug | General, Regional |
Primary outcome
Total Hydrocodone Dose (mg/kg)
Time frame: day 2 and day 8 after the surgery
1 secondary outcome
Patient/Family Satisfaction With Pain Management
Time frame: one week after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22786464Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
- Background: PubMed 18498436Segerdahl M, Warren-Stomberg M, Rawal N, Brattwall M, Jakobsson J. Children in day surgery: clinical practice and routines. The results from a nation-wide survey. Acta Anaesthesiol Scand. 2008 Jul;52(6):821-8. doi: 10.1111/j.1399-6576.2008.01669.x. Epub 2008 May 21.
- Background: PubMed 24330523Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11.
- Background: PubMed 24407716Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.
- Background: PubMed 21895855Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available.
- Background: PubMed 21951324Polaner DM, Martin LD; PRAN Investigators. Quality assurance and improvement: the Pediatric Regional Anesthesia Network. Paediatr Anaesth. 2012 Jan;22(1):115-9. doi: 10.1111/j.1460-9592.2011.03708.x. Epub 2011 Sep 27.
- Background: PubMed 21199114Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.
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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. This study is not recruiting at the moment.
madhankumar sathyamoorthy, MBBS, MS principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional block, General Anesthesia and Local Anesthetic Ropivacaine in people with Pediatric Extremity Fracture and Pediatric Extremity Soft Tissue Injury, run by University of Mississippi Medical Center 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Feb 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Hydrocodone Dose (mg/kg) (time frame: day 2 and day 8 after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236130, which also lists 7 linked publications.
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 13 Feb 2017.