Hip SurgeryNCT03435692
Post Operative Pain Control After Pediatric Hip Surgery
A study testing Lumbar Plexus Catheter, Lumbar Epidural Catheter and Fentanyl in people with Hip Surgery and Post Operative Pain Control, run by Seattle Children's Hospital.
Trial summary
Hip surgery in children is painful and the optimal modality for managing post-operative pain has not been established. This prospective randomized controlled trail compares lumbar plexus catheter (LPC), lumbar epidural catheter (LEC) and continuous patient-controlled analgesia (PCA) with intravenous morphine. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Surgery, Post Operative Pain Control
- What is being tested?
- Lumbar Plexus Catheter, Lumbar Epidural Catheter and Fentanyl
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2011to 29 Jul 2014
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children undergoing unilateral hip surgery, including pelvic innominate osteotomies, proximal femoral osteotomies, and arthrotomies (for open reduction, loose body removal, labral debridement or labral repair).
Who cannot join
- History of a previous spine surgery, spina bifida, coagulopathy, skin infection, allergies to study medications (i.e. local anesthetics and opioids), patients taking opioids at the time of enrollment and, those having concurrent procedures distal to the hip.
About this study
Official title: Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial
Hip surgery in children is painful and the optimal modality for managing post-operative pain has not been established. This prospective randomized controlled trail compares lumbar plexus catheter (LPC), lumbar epidural catheter (LEC) and continuous patient-controlled analgesia (PCA) with intravenous morphine.
Read the detailed description
Approximately 1 in 1,000 children born in the US have hip dislocation and 10 in 1,000 have hip subluxation requiring surgical intervention. Pain after major hip surgery in children is severe, yet there is no agreement on the most effective method for pain control. Post-operative pain modalities including lumbar epidural catheters (LEC), lumbar plexus catheters (LPC) and intravenous patient controlled analgesia (IV-PCA) have been described. IV-PCA has historically been the standard of care in spite of its numerous associated side effects. Regional anesthesia modalities have gained popularity because of superior pain control with lower opioid requirements.
In this study, the investigators describe the first prospective randomized controlled trial comparing lumbar plexus catheter to alternatives for post-operative pain management in children after major hip surgery. The investigators hypothesized that LPC would be as safe and efficacious as LEC and IV-PCA with the added advantage of a decreased length of stay. The investigators primary aim was to compare hospital length of stay. Secondary aim was to compare pain scores, opioid consumption and opioid-related side effects.
- Conditions
- Hip Surgery, Post Operative Pain Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Plexus CatheterProcedure or surgery
Also called LPC
lumbar plexus catheter placed intraoperatively for perioperative pain control
Lumbar Epidural CatheterProcedure or surgery
Also called LEC
lumbar epidural catheter placed intraoperatively for perioperative pain control
Patient Controlled AnalgesiaProcedure or surgery
Also called PCA
Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control
FentanylDrug
Intravenous fentanyl was administered in the operating room for induction of anesthesia. Subsequent doses in the operating room were standardized to be given only for heart rate or blood pressure increases > 20% above baseline and occurring more than 30 minutes after the block if applicable.
MorphineDrug
In the operating room patients, intravenous morphine was administered if patients had a failed block and standardized to be given only for heart rate or blood pressure increases > 20% above baseline and after fentanyl had been administered. Intravenous Morphine was also administered in the operating room if the patient was randomized to the Patient Controlled Analgesia (PCA) arm of the study. Post operatively intravenous Morphine was administered as needed for severe pain.
LorazepamDrug
Also called Ativan
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
OndansetronDrug
Also called Zofran
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
DiphenhydramineDrug
Also called Benadryl
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
AcetaminophenDrug
Also called Tylenol
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
OxycodoneDrug
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
RopivacaineDrug
Intravenous Ropivacaine was administered as part of the initial bolus after placement of the lumbar epidural or lumbar plexus catheter and then as a continuous infusion post operatively.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Plexus Catheter | Experimental | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen. Receives: Procedure: Lumbar Plexus Catheter; Drug: Fentanyl; Drug: Morphine; Drug: Lorazepam; Drug: Ondansetron; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Oxycodone; Drug: Ropivacaine |
| Lumbar Epidural Catheter | Active comparator | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.
An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen. Receives: Procedure: Lumbar Epidural Catheter; Drug: Fentanyl; Drug: Morphine; Drug: Lorazepam; Drug: Ondansetron; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Oxycodone; Drug: Ropivacaine |
| Patient Controlled Analgesia | Active comparator | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen. Receives: Procedure: Patient Controlled Analgesia; Drug: Fentanyl; Drug: Morphine; Drug: Lorazepam; Drug: Ondansetron; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Total hospital length of stay
Measured: Through hospital stay, an average of 2-3 days.
Maximum Pain Score
Mean of Maximum Pain Score POD 0-2
Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC) for children 1-3 years of age, Faces Pain Scale - Revised (FPS-R) for children over age 3 and the Numeric scale (0-10) for children over age 7.
minimum value = 0, maximum value 10 (higher score is worse)
Measured: Post-Operative Days 0-2
Total Perioperative Morphine Equivalents
All administered opioids measured as morphine equivalents (mg/kg)
Measured: Post-Operative Days 0-2
Secondary outcomes (3)
Nausea
% of patients with nausea
Measured: Post-Operative Days 0-2
Itching
% of patients with itching
Measured: Post-Operative Days 0-2
Muscle Spasm
% of patients w/ muscle spasm
Measured: Post-Operative days 0-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Jul 2011
- Primary completion29 Jul 2014
- Study completion29 Jul 2014
Why it stopped: Funding was exhausted prior to enrolling intended number 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 (5)Papers the sponsor has linked to this study.
- Other trials for Hip SurgeryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Liston, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435692
- Sponsor's protocol ID
- 13144
- Status last verified
- Oct 2021
- First submitted
- 30 Jan 2018
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tredwell SJ. Neonatal screening for hip joint instability. Its clinical and economic relevance. Clin Orthop Relat Res. 1992 Aug;(281):63-8.
PubMed 1499229Horlocker TT, Kopp SL, Pagnano MW, Hebl JR. Analgesia for total hip and knee arthroplasty: a multimodal pathway featuring peripheral nerve block. J Am Acad Orthop Surg. 2006 Mar;14(3):126-35. doi: 10.5435/00124635-200603000-00003.
PubMed 16520363Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;2003(3):CD003071. doi: 10.1002/14651858.CD003071.
PubMed 12917945Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.
PubMed 19122076Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
PubMed 14612482
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03435692
- Acronym / sponsor ID
- 13144
- Conditions
- Hip Surgery, Post Operative Pain Control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was exhausted prior to enrolling intended number of patients.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2011 (actual)
- Primary completion
- 29 Jul 2014 (actual)
- Study completion
- 29 Jul 2014 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip surgery in children is painful and the optimal modality for managing post-operative pain has not been established. This prospective randomized controlled trail compares lumbar plexus catheter (LPC), lumbar epidural catheter (LEC) and continuous patient-controlled analgesia (PCA) with intravenous morphine.
Detailed description
Approximately 1 in 1,000 children born in the US have hip dislocation and 10 in 1,000 have hip subluxation requiring surgical intervention. Pain after major hip surgery in children is severe, yet there is no agreement on the most effective method for pain control. Post-operative pain modalities including lumbar epidural catheters (LEC), lumbar plexus catheters (LPC) and intravenous patient controlled analgesia (IV-PCA) have been described. IV-PCA has historically been the standard of care in spite of its numerous associated side effects. Regional anesthesia modalities have gained popularity because of superior pain control with lower opioid requirements.
In this study, the investigators describe the first prospective randomized controlled trial comparing lumbar plexus catheter to alternatives for post-operative pain management in children after major hip surgery. The investigators hypothesized that LPC would be as safe and efficacious as LEC and IV-PCA with the added advantage of a decreased length of stay. The investigators primary aim was to compare hospital length of stay. Secondary aim was to compare pain scores, opioid consumption and opioid-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar Plexus Catheter | Experimental | Procedure: Lumbar Plexus Catheter, Drug: Fentanyl, Drug: Morphine, Drug: Lorazepam, Drug: Ondansetron, Drug: Diphenhydramine, Drug: Acetaminophen, Drug: Oxycodone, Drug: RopivacaineChildren undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen. |
| Lumbar Epidural Catheter | Active comparator | Procedure: Lumbar Epidural Catheter, Drug: Fentanyl, Drug: Morphine, Drug: Lorazepam, Drug: Ondansetron, Drug: Diphenhydramine, Drug: Acetaminophen, Drug: Oxycodone, Drug: RopivacaineChildren undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen. |
| Patient Controlled Analgesia | Active comparator | Procedure: Patient Controlled Analgesia, Drug: Fentanyl, Drug: Morphine, Drug: Lorazepam, Drug: Ondansetron, Drug: Diphenhydramine, Drug: Acetaminophen, Drug: OxycodoneChildren undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. An intraoperative pain protocol will dictate if the patient will receive intravenous fentanyl or morphine. Post operative side effects will be controlled with the administration of ondansetron for nausea and vomiting, diphenhydramine for itching, and lorazepam for muscle spasms. Post operative pain control will be managed with as needed (PRN) morphine and oxycodone as well as scheduled acetaminophen. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children undergoing unilateral hip surgery, including pelvic innominate osteotomies, proximal femoral osteotomies, and arthrotomies (for open reduction, loose body removal, labral debridement or labral repair).
Key exclusion criteria (1 listed)
- History of a previous spine surgery, spina bifida, coagulopathy, skin infection, allergies to study medications (i.e. local anesthetics and opioids), patients taking opioids at the time of enrollment and, those having concurrent procedures distal to the hip.
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 |
|---|---|---|
| Lumbar Plexus CatheterAlso: LPClumbar plexus catheter placed intraoperatively for perioperative pain control | Procedure or surgery | Lumbar Plexus Catheter |
| Lumbar Epidural CatheterAlso: LEClumbar epidural catheter placed intraoperatively for perioperative pain control | Procedure or surgery | Lumbar Epidural Catheter |
| Patient Controlled AnalgesiaAlso: PCAPatient Controlled Analgesia (PCA) was started post operatively for perioperative pain control | Procedure or surgery | Patient Controlled Analgesia |
| FentanylIntravenous fentanyl was administered in the operating room for induction of anesthesia. Subsequent doses in the operating room were standardized to be given only for heart rate or blood pressure increases > 20% above baseline and occurring more than 30 minutes after the block if applicable. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter, Patient Controlled Analgesia |
| MorphineIn the operating room patients, intravenous morphine was administered if patients had a failed block and standardized to be given only for heart rate or blood pressure increases > 20% above baseline and after fentanyl had been administered. Intravenous Morphine was also administered in the operating room if the patient was randomized to the Patient Controlled Analgesia (PCA) arm of the study. Post operatively intravenous Morphine was administered as needed for severe pain. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter, Patient Controlled Analgesia |
| LorazepamAlso: AtivanIntravenous Lorazepam was administered as needed for muscle spasm post operatively. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter, Patient Controlled Analgesia |
| OndansetronAlso: ZofranIntravenous Ondansetron was administered as needed for nausea and vomiting post operatively. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter, Patient Controlled Analgesia |
| DiphenhydramineAlso: BenadrylIntravenous Diphenhydramine was administered as needed for itching postoperatively. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter, Patient Controlled Analgesia |
| AcetaminophenAlso: TylenolOral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter, Patient Controlled Analgesia |
| OxycodoneOral Oxycodone was administered as needed for breakthrough pain post operatively. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter, Patient Controlled Analgesia |
| RopivacaineIntravenous Ropivacaine was administered as part of the initial bolus after placement of the lumbar epidural or lumbar plexus catheter and then as a continuous infusion post operatively. | Drug | Lumbar Epidural Catheter, Lumbar Plexus Catheter |
Primary outcome
Hospital Length of Stay
Time frame: Through hospital stay, an average of 2-3 days.
Total hospital length of stay
Maximum Pain Score
Time frame: Post-Operative Days 0-2
Mean of Maximum Pain Score POD 0-2 Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC) for children 1-3 years of age, Faces Pain Scale - Revised (FPS-R) for children over age 3 and the Numeric scale (0-10) for children over age 7. minimum value = 0, maximum value 10 (higher score is worse)
Total Perioperative Morphine Equivalents
Time frame: Post-Operative Days 0-2
All administered opioids measured as morphine equivalents (mg/kg)
3 secondary outcomes
Nausea
Time frame: Post-Operative Days 0-2
Itching
Time frame: Post-Operative Days 0-2
Muscle Spasm
Time frame: Post-Operative days 0-2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1499229Tredwell SJ. Neonatal screening for hip joint instability. Its clinical and economic relevance. Clin Orthop Relat Res. 1992 Aug;(281):63-8.
- Background: PubMed 16520363Horlocker TT, Kopp SL, Pagnano MW, Hebl JR. Analgesia for total hip and knee arthroplasty: a multimodal pathway featuring peripheral nerve block. J Am Acad Orthop Surg. 2006 Mar;14(3):126-35. doi: 10.5435/00124635-200603000-00003.
- Background: PubMed 12917945Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;2003(3):CD003071. doi: 10.1002/14651858.CD003071.
- Background: PubMed 19122076Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.
- Background: PubMed 14612482Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Plexus Catheter, Lumbar Epidural Catheter and Fentanyl in people with Hip Surgery and Post Operative Pain Control, run by Seattle Children's Hospital.
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 1 inclusion and 1 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 Nov 2021). 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?
Hospital Length of Stay (time frame: Through hospital stay, an average of 2-3 days.). The study lists 3 primary outcomes in all. 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 NCT03435692, which also lists 5 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 2 Nov 2021.