Back to resultsPost Operative Pain Control After Pediatric Hip Surgery
Primary Purpose
Hip Surgery, Post Operative Pain Control
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lumbar Plexus Catheter
Lumbar Epidural Catheter
Patient Controlled Analgesia
Fentanyl
Morphine
Lorazepam
Ondansetron
Diphenhydramine
Acetaminophen
Oxycodone
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Hip Surgery
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Lumbar Plexus Catheter
Lumbar Epidural Catheter
Patient Controlled Analgesia
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Hospital Length of Stay
Total hospital length of stay
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)
Total Perioperative Morphine Equivalents
All administered opioids measured as morphine equivalents (mg/kg)
Secondary Outcome Measures
Nausea
% of patients with nausea
Itching
% of patients with itching
Muscle Spasm
% of patients w/ muscle spasm
Full Information
NCT ID
NCT03435692
First Posted
January 30, 2018
Last Updated
October 4, 2021
Sponsor
Seattle Children's Hospital
Collaborators
Seattle Children's Research Institute Center for Clinical and Translational Research
1. Study Identification
Unique Protocol Identification Number
NCT03435692
Brief Title
Post Operative Pain Control After Pediatric Hip Surgery
Official Title
Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding was exhausted prior to enrolling intended number of patients.
Study Start Date
July 15, 2011 (Actual)
Primary Completion Date
July 29, 2014 (Actual)
Study Completion Date
July 29, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Seattle Children's Research Institute Center for Clinical and Translational Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Surgery, Post Operative Pain Control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lumbar Plexus Catheter
Arm Type
Experimental
Arm Description
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.
Arm Title
Lumbar Epidural Catheter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patient Controlled Analgesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lumbar Plexus Catheter
Other Intervention Name(s)
LPC
Intervention Description
lumbar plexus catheter placed intraoperatively for perioperative pain control
Intervention Type
Procedure
Intervention Name(s)
Lumbar Epidural Catheter
Other Intervention Name(s)
LEC
Intervention Description
lumbar epidural catheter placed intraoperatively for perioperative pain control
Intervention Type
Procedure
Intervention Name(s)
Patient Controlled Analgesia
Other Intervention Name(s)
PCA
Intervention Description
Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Other Intervention Name(s)
Ativan
Intervention Description
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Intervention Description
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Total hospital length of stay
Time Frame
Through hospital stay, an average of 2-3 days.
Title
Maximum Pain Score
Description
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)
Time Frame
Post-Operative Days 0-2
Title
Total Perioperative Morphine Equivalents
Description
All administered opioids measured as morphine equivalents (mg/kg)
Time Frame
Post-Operative Days 0-2
Secondary Outcome Measure Information:
Title
Nausea
Description
% of patients with nausea
Time Frame
Post-Operative Days 0-2
Title
Itching
Description
% of patients with itching
Time Frame
Post-Operative Days 0-2
Title
Muscle Spasm
Description
% of patients w/ muscle spasm
Time Frame
Post-Operative days 0-2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
1499229
Citation
Tredwell SJ. Neonatal screening for hip joint instability. Its clinical and economic relevance. Clin Orthop Relat Res. 1992 Aug;(281):63-8.
Results Reference
background
PubMed Identifier
16520363
Citation
Horlocker 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.
Results Reference
background
PubMed Identifier
12917945
Citation
Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;(3):CD003071. doi: 10.1002/14651858.CD003071.
Results Reference
background
PubMed Identifier
19122076
Citation
Marino 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.
Results Reference
background
PubMed Identifier
14612482
Citation
Block 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.
Results Reference
background
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Post Operative Pain Control After Pediatric Hip Surgery
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