Cerebral PalsyPhase 4NCT06189781
Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
A Phase 4 study testing Ropivacaine injection and Bupivacaine, lidocaine, ropivacaine in people with Cerebral Palsy and Hip Dysplasia, run by University of California, Los Angeles at 4 sites in United States.
Trial summary
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cerebral Palsy, Hip Dysplasia, Pain, Postoperative
- What is being tested?
- Ropivacaine injection and Bupivacaine, lidocaine, ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2023to 30 Jun 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- under 18 years old
- diagnosis of cerebral palsy or similar neuromuscular disease
- undergoing uni- or bilateral proximal femoral osteotomy
Who cannot join
- ongoing preoperative opioid use
- history of allergic reaction to any component of the pain injection
- history of adverse reaction to epidural anesthesia
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Elizabeth Klein, eklein@luriechildrens.org
Vineeta T Swaroop, MD
- Recruiting
Orthopaedic Institute for Children
Los Angeles, California, 90007
Nicole J Hung, MD, 310-592-5180
Rachel M Thompson, MD
- Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Nicole J Hung, MD, 310-592-5180, nhung@mednet.ucla.edu
Rachel M Thompson, MD
- Recruiting
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
Nicole J Hung, MD, 310-592-5180
Rachel M Thompson, MD
About this study
Official title: Peri-operative Use of a Pain Injection Versus Epidural in Pediatric Patients With Cerebral Palsy
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression.
Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.
Read the detailed description
Over the past decade, there has been an ongoing shift away from the use of opioids in the postoperative setting due to both their negative side effects and their high potential for dependence and abuse. Various new techniques for multimodal pain management are increasingly being utilized in adult orthopaedics, including injection of local anesthetics and analgesic agents. These techniques aim to block pain directly at the site of injection in order to reduce postoperative pain while minimizing systemic effects and preserving motor function, allowing for early mobilization. Numerous randomized controlled trials in both the arthroplasty and adult trauma populations have demonstrated reduced pain and narcotic consumption with local analgesia injection, but there is scant evidence on the efficacy of similar injections in pediatric surgical patients. While robust evidence demonstrating both safety and efficacy of these injections has led to routine use in the adult orthopaedic population, use in pediatric patients still remains limited, likely due to a lack of level I therapeutic evidence.
Local anesthetic injections offer several theoretical advantages over current pain management modalities. When compared with other methods of anesthesia, including epidural anesthesia or some peripheral nerve blocks, local anesthetic injections preserve motor function, allowing for early mobilization and rehabilitation. Additionally, they do not require specialized equipment or anesthesia personnel and can be administered in the operating room without significantly affecting the duration of the procedure. While a mainstay in traditional pain management protocols, epidural anesthesia in the pediatric CP population poses specific risks including damage to preexisting intrathecal baclofen pumps and iatrogenic infection. Moreover, epidural insertion can be a technically demanding procedure in these patients given high rates of concomitant neuromuscular scoliosis. Prior retrospective studies comparing peripheral nerve and lumbar plexus blocks compared to epidural anesthesia have shown mixed results in decreasing pain scores and opioid use in this patient population. As described in Preliminary Data section below, the investigators' pilot randomized control trial demonstrated significantly decreased pain scores and narcotic use postoperatively in pediatric patients with CP who received multimodal analgesia injection compared to placebo while undergoing hip surgery. The present study aims to substantively contribute to current literature by providing level I evidence comparing the safety and efficacy of surgical site injections with epidural anesthesia in a patient population for whom pain management remains challenging.
- Conditions
- Cerebral Palsy, Hip Dysplasia, Pain, Postoperative
- Being tested
- Ropivacaine injection, Bupivacaine, lidocaine, ropivacaine
- Medical subject headings
- Cerebral Palsy, Hip Dislocation, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
The local anesthetic group will be injected with ropivacaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), and ketorolac 30mg/mL (0.5mg/kg). The maximum dose of ropivacaine regardless of patient weight will be 200mg. This is based on recommended maximum dose protocols from our anesthesia colleagues. If bilateral hips are involved, the total amount will be split evenly between the two sides.
Bupivacaine, lidocaine, ropivacaineDrug
The lumbar epidural group will receive a combination of either/or bupivacaine, lidocaine, and ropivacaine, which will be monitored by the anesthesia team.
| Study group | Role | What they receive |
|---|---|---|
| Pain Injection | Experimental | The local anesthetic group will be injected with a combination of ropivacaine, epinephrine, and ketorolac. Receives: Drug: Ropivacaine injection |
| Epidural | Active comparator | The control group will receive epidural anesthesia. Lumbar epidural anesthesia will be started intra-operatively. Receives: Drug: Bupivacaine, lidocaine, ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight
This describes one outcome measure where the amount of opiates consumed will be expressed in morphine equivalents divided by the body weight of patients measured in kilograms.
Measured: First 48 hours after surgery
Secondary outcomes (3)
Postoperative pain scores measured by Visual Analogue Scale/Faces Pain Scale/Face, Legs, Activity, Cry, Consolability Scale
Pain score assessments will be completed in the post-anesthesia care unit, and every 4 hours following the surgical procedure. Scores will be collected by nursing staff on the inpatient ward and recorded in the electronic medical record. The type of pain score collection will vary based on patient age and level of intellectual disability. In verbal children, either the Visual Analogue Scale or Faces Pain Scale will be employed. In non-verbal children, the Face, Legs, Activity, Cry, Consolability Scale will be employed. A higher score indicates greater pain intensity. Both scales are from 0 (minimum) -10 (maximum), where 0 indicates no pain and 10 indicate maximal pain.
Measured: 2-4 days
Hospital length of stay measured in days
Postoperative hospital length of stay
Measured: 2-4 days
Parent satisfaction measured on a scale of 1-5
Parent satisfaction will be based on a standardized, validated questionnaire taken by parents in person at the first post-operative clinic visit aimed to assess their satisfaction with their child's pain management peri-operatively. Each question is answered with a score of either 1-5, with 1 being the best outcome and 5 being the worst outcome. The score for each question will be summed together to come up with a total score. A higher total score indicates a worse level of satisfaction with perioperative pain management.
Measured: 2-3 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Dec 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Patients will be assigned to either treatment/intervention group (injection only) or control (epidural only). All other aspects of care will be identical between the two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Principal investigator, Rachel Thompson, MD, University of California, Los Angeles
- Investigators
- Rachel M Thompson, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189781
- Sponsor's protocol ID
- IRB#23-000902
- Status last verified
- Jun 2024
- First submitted
- 13 Dec 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson KB, Emery ES 3rd. Birth asphyxia and the neonatal brain: what do we know and when do we know it? Clin Perinatol. 1993 Jun;20(2):327-44.
PubMed 8358954Nolan J, Chalkiadis GA, Low J, Olesch CA, Brown TC. Anaesthesia and pain management in cerebral palsy. Anaesthesia. 2000 Jan;55(1):32-41. doi: 10.1046/j.1365-2044.2000.01065.x.
PubMed 10594431Tabaie S, Shah A, Tarawneh O, Blaylock G, Sheppard E, Cho K. Use of Epidural Analgesia in Children With Neuromuscular Conditions Following Hip Reconstruction. Cureus. 2022 Oct 20;14(10):e30522. doi: 10.7759/cureus.30522. eCollection 2022 Oct.
PubMed 36285108Hauer J, Houtrow AJ; SECTION ON HOSPICE AND PALLIATIVE MEDICINE, COUNCIL ON CHILDREN WITH DISABILITIES. Pain Assessment and Treatment in Children With Significant Impairment of the Central Nervous System. Pediatrics. 2017 Jun;139(6):e20171002. doi: 10.1542/peds.2017-1002.
PubMed 28562301McKearnan KA, Kieckhefer GM, Engel JM, Jensen MP, Labyak S. Pain in children with cerebral palsy: a review. J Neurosci Nurs. 2004 Oct;36(5):252-9. doi: 10.1097/01376517-200410000-00004.
PubMed 15524243Ciccozzi A, Pizzi B, Vittori A, Piroli A, Marrocco G, Della Vecchia F, Cascella M, Petrucci E, Marinangeli F. The Perioperative Anesthetic Management of the Pediatric Patient with Special Needs: An Overview of Literature. Children (Basel). 2022 Sep 21;9(10):1438. doi: 10.3390/children9101438.
PubMed 36291372Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
PubMed 14622770Piper NA, Flack SH, Loeser JD, Lynn AM. Epidural analgesia in a patient with an intrathecal catheter and subcutaneous pump to deliver baclofen. Paediatr Anaesth. 2006 Sep;16(9):989-92. doi: 10.1111/j.1460-9592.2006.01908.x.
PubMed 16918665Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.
PubMed 31563269Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.
PubMed 16452738Peters CL, Shirley B, Erickson J. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):132-8. doi: 10.1016/j.arth.2006.04.017.
PubMed 16950075Andersen KV, Pfeiffer-Jensen M, Haraldsted V, Soballe K. Reduced hospital stay and narcotic consumption, and improved mobilization with local and intraarticular infiltration after hip arthroplasty: a randomized clinical trial of an intraarticular technique versus epidural infusion in 80 patients. Acta Orthop. 2007 Apr;78(2):180-6. doi: 10.1080/17453670710013654.
PubMed 17464604Koehler D, Marsh JL, Karam M, Fruehling C, Willey M. Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 15;99(6):512-519. doi: 10.2106/JBJS.16.00733.
PubMed 28291185Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
PubMed 16651569Uesugi K, Kitano N, Kikuchi T, Sekiguchi M, Konno S. Comparison of peripheral nerve block with periarticular injection analgesia after total knee arthroplasty: a randomized, controlled study. Knee. 2014 Aug;21(4):848-52. doi: 10.1016/j.knee.2014.04.008. Epub 2014 Apr 18.
PubMed 24827696
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Use of a Pain Injection Versus Epidural in Pediatric Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06189781
- Acronym / sponsor ID
- IRB#23-000902
- Conditions
- Cerebral Palsy, Hip Dysplasia, Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Jan 2024 (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.
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression.
Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.
Detailed description
Over the past decade, there has been an ongoing shift away from the use of opioids in the postoperative setting due to both their negative side effects and their high potential for dependence and abuse. Various new techniques for multimodal pain management are increasingly being utilized in adult orthopaedics, including injection of local anesthetics and analgesic agents. These techniques aim to block pain directly at the site of injection in order to reduce postoperative pain while minimizing systemic effects and preserving motor function, allowing for early mobilization. Numerous randomized controlled trials in both the arthroplasty and adult trauma populations have demonstrated reduced pain and narcotic consumption with local analgesia injection, but there is scant evidence on the efficacy of similar injections in pediatric surgical patients. While robust evidence demonstrating both safety and efficacy of these injections has led to routine use in the adult orthopaedic population, use in pediatric patients still remains limited, likely due to a lack of level I therapeutic evidence.
Local anesthetic injections offer several theoretical advantages over current pain management modalities. When compared with other methods of anesthesia, including epidural anesthesia or some peripheral nerve blocks, local anesthetic injections preserve motor function, allowing for early mobilization and rehabilitation. Additionally, they do not require specialized equipment or anesthesia personnel and can be administered in the operating room without significantly affecting the duration of the procedure. While a mainstay in traditional pain management protocols, epidural anesthesia in the pediatric CP population poses specific risks including damage to preexisting intrathecal baclofen pumps and iatrogenic infection. Moreover, epidural insertion can be a technically demanding procedure in these patients given high rates of concomitant neuromuscular scoliosis. Prior retrospective studies comparing peripheral nerve and lumbar plexus blocks compared to epidural anesthesia have shown mixed results in decreasing pain scores and opioid use in this patient population. As described in Preliminary Data section below, the investigators' pilot randomized control trial demonstrated significantly decreased pain scores and narcotic use postoperatively in pediatric patients with CP who received multimodal analgesia injection compared to placebo while undergoing hip surgery. The present study aims to substantively contribute to current literature by providing level I evidence comparing the safety and efficacy of surgical site injections with epidural anesthesia in a patient population for whom pain management remains challenging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to either treatment/intervention group (injection only) or control (epidural only). All other aspects of care will be identical between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Pain Injection | Experimental | Drug: Ropivacaine injectionThe local anesthetic group will be injected with a combination of ropivacaine, epinephrine, and ketorolac. |
| Epidural | Active comparator | Drug: Bupivacaine, lidocaine, ropivacaineThe control group will receive epidural anesthesia. Lumbar epidural anesthesia will be started intra-operatively. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- under 18 years old
- diagnosis of cerebral palsy or similar neuromuscular disease
- undergoing uni- or bilateral proximal femoral osteotomy
Key exclusion criteria (3 listed)
- ongoing preoperative opioid use
- history of allergic reaction to any component of the pain injection
- history of adverse reaction to epidural anesthesia
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 |
|---|---|---|
| Ropivacaine injectionThe local anesthetic group will be injected with ropivacaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), and ketorolac 30mg/mL (0.5mg/kg). The maximum dose of ropivacaine regardless of patient weight will be 200mg. This is based on recommended maximum dose protocols from our anesthesia colleagues. If bilateral hips are involved, the total amount will be split evenly between the two sides. | Drug | Pain Injection |
| Bupivacaine, lidocaine, ropivacaineThe lumbar epidural group will receive a combination of either/or bupivacaine, lidocaine, and ropivacaine, which will be monitored by the anesthesia team. | Drug | Epidural |
Primary outcome
Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight
Time frame: First 48 hours after surgery
This describes one outcome measure where the amount of opiates consumed will be expressed in morphine equivalents divided by the body weight of patients measured in kilograms.
3 secondary outcomes
Postoperative pain scores measured by Visual Analogue Scale/Faces Pain Scale/Face, Legs, Activity, Cry, Consolability Scale
Time frame: 2-4 days
Hospital length of stay measured in days
Time frame: 2-4 days
Parent satisfaction measured on a scale of 1-5
Time frame: 2-3 weeks postoperatively
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 11 Jun 2024.
- Background: PubMed 8358954Nelson KB, Emery ES 3rd. Birth asphyxia and the neonatal brain: what do we know and when do we know it? Clin Perinatol. 1993 Jun;20(2):327-44.
- Background: PubMed 10594431Nolan J, Chalkiadis GA, Low J, Olesch CA, Brown TC. Anaesthesia and pain management in cerebral palsy. Anaesthesia. 2000 Jan;55(1):32-41. doi: 10.1046/j.1365-2044.2000.01065.x.
- Background: PubMed 36285108Tabaie S, Shah A, Tarawneh O, Blaylock G, Sheppard E, Cho K. Use of Epidural Analgesia in Children With Neuromuscular Conditions Following Hip Reconstruction. Cureus. 2022 Oct 20;14(10):e30522. doi: 10.7759/cureus.30522. eCollection 2022 Oct.
- Background: PubMed 28562301Hauer J, Houtrow AJ; SECTION ON HOSPICE AND PALLIATIVE MEDICINE, COUNCIL ON CHILDREN WITH DISABILITIES. Pain Assessment and Treatment in Children With Significant Impairment of the Central Nervous System. Pediatrics. 2017 Jun;139(6):e20171002. doi: 10.1542/peds.2017-1002.
- Background: PubMed 15524243McKearnan KA, Kieckhefer GM, Engel JM, Jensen MP, Labyak S. Pain in children with cerebral palsy: a review. J Neurosci Nurs. 2004 Oct;36(5):252-9. doi: 10.1097/01376517-200410000-00004.
- Background: PubMed 36291372Ciccozzi A, Pizzi B, Vittori A, Piroli A, Marrocco G, Della Vecchia F, Cascella M, Petrucci E, Marinangeli F. The Perioperative Anesthetic Management of the Pediatric Patient with Special Needs: An Overview of Literature. Children (Basel). 2022 Sep 21;9(10):1438. doi: 10.3390/children9101438.
- Background: PubMed 14622770Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
- Background: PubMed 16918665Piper NA, Flack SH, Loeser JD, Lynn AM. Epidural analgesia in a patient with an intrathecal catheter and subcutaneous pump to deliver baclofen. Paediatr Anaesth. 2006 Sep;16(9):989-92. doi: 10.1111/j.1460-9592.2006.01908.x.
- Background: PubMed 31563269Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 Sep 25.
- Background: PubMed 16452738Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. doi: 10.2106/JBJS.E.00173.
- Background: PubMed 16950075Peters CL, Shirley B, Erickson J. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):132-8. doi: 10.1016/j.arth.2006.04.017.
- Background: PubMed 17464604Andersen KV, Pfeiffer-Jensen M, Haraldsted V, Soballe K. Reduced hospital stay and narcotic consumption, and improved mobilization with local and intraarticular infiltration after hip arthroplasty: a randomized clinical trial of an intraarticular technique versus epidural infusion in 80 patients. Acta Orthop. 2007 Apr;78(2):180-6. doi: 10.1080/17453670710013654.
- 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.
Rachel M Thompson, MD principal investigator
University of California, Los Angeles
4 sites 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 injection and Bupivacaine, lidocaine, ropivacaine in people with Cerebral Palsy and Hip Dysplasia, run by University of California, Los Angeles at 4 sites 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 3 inclusion and 3 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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 Rachel M Thompson, MD (213-742-1369, rathompson@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight (time frame: First 48 hours after 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 NCT06189781, which also lists 16 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 11 Jun 2024.