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Funding was exhausted prior to enrolling intended number of patients.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar Plexus Catheter | Procedure | lumbar plexus catheter placed intraoperatively for perioperative pain control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Total hospital length of stay | 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) | Post-Operative Days 0-2 |
| Total Perioperative Morphine Equivalents | All administered opioids measured as morphine equivalents (mg/kg) | Post-Operative Days 0-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea | % of patients with nausea | Post-Operative Days 0-2 |
| Itching | % of patients with itching | Post-Operative Days 0-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1499229 | Background | Tredwell SJ. Neonatal screening for hip joint instability. Its clinical and economic relevance. Clin Orthop Relat Res. 1992 Aug;(281):63-8. | |
| 16520363 | Background | 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. |
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53 patients were assessed and approached for study eligibility. 10 patients refused to participate and 1 patient did not meet inclusion criteria after initial assessment. 42 patients were enrolled and randomized to study groups.
All patients were recruited at Seattle Children's Hospital main campus location. Recruitment period ran from 7/15/11 to 7/29/14.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumbar Epidural Catheter | 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 IV 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. |
| FG001 | Lumbar Plexus Catheter | 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 IV 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 PRN morphine and oxycodone as well as scheduled acetaminophen. |
| FG002 | Patient Controlled Analgesia | 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 IV 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 PRN morphine and oxycodone as well as scheduled acetaminophen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumbar Epidural Catheter (< 6 Years Old) | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. |
| BG001 | Lumbar Plexus Catheter (< 6 Years Old) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospital Length of Stay | Total hospital length of stay | Posted | Mean | Standard Deviation | days | Through hospital stay, an average of 2-3 days. |
|
Up to 5 days
Adverse event data was collected from the time of enrollment through the participants' study completion. Study completion was defined as when subjects were either discharged from the hospital or removal of the study catheter (lumbar plexus catheter or lumbar epidural catheter) occurred; whichever occurred later. This time period was on average 3 days and no longer than 5 days total.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumbar Epidural Catheter (< 6 Years Old) | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. |
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This study was terminated early because funding was exhausted prior to enrolling intended number of patients. Based on the pre study power analysis we planned to recruit 75 patients; however, we were only able to enroll 42 patients due to limited funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David E. Liston, MD, MPH | Seattle Children's Hospital | 206-987-3996 | david.liston@seattlechildrens.org |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| D010323 | Passive Cutaneous Anaphylaxis |
| D005283 | Fentanyl |
| D009020 | Morphine |
| D008140 | Lorazepam |
| D017294 | Ondansetron |
| D004155 | Diphenhydramine |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
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|
| Lumbar Epidural Catheter | Procedure | lumbar epidural catheter placed intraoperatively for perioperative pain control |
|
|
| Patient Controlled Analgesia | Procedure | Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control |
|
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| Fentanyl | Drug | 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. |
|
| Morphine | Drug | 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. |
|
| Lorazepam | Drug | Intravenous Lorazepam was administered as needed for muscle spasm post operatively. |
|
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| Ondansetron | Drug | Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively. |
|
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| Diphenhydramine | Drug | Intravenous Diphenhydramine was administered as needed for itching postoperatively. |
|
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| Acetaminophen | Drug | Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours. |
|
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| Oxycodone | Drug | Oral Oxycodone was administered as needed for breakthrough pain post operatively. |
|
| Ropivacaine | Drug | 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. |
|
| Muscle Spasm | % of patients w/ muscle spasm | Post-Operative days 0-2 |
| 12917945 | Background | Choi 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. |
| 19122076 | Background | 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. |
| 14612482 | Background | 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. |
Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. |
| BG002 | Lumbar Epidural Catheter (6 Years and Older) | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. |
| BG003 | Lumbar Plexus Catheter (6 Years and Older) | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. |
| BG004 | Patient Controlled Analgesia (6 Years and Older) | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| American Society of Anesthesiologists (ASA) Physical Status Classification System | The American Society of Anesthesiologists (ASA) Physical Status Classification System purpose is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA I is a normal healthy patient. ASA II is a patient with mild systemic disease. ASA III is a patient with severe systemic disease. ASA IV is a patient with severe systemic disease that is a constant threat to life. ASA V is a moribund patient who is not expected to survive without the operation. ASA VI is a declared brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
|
| Surgical Approach | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| OG002 |
| Lumbar Epidural Catheter (6 Years and Older) |
Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. |
| OG003 | Lumbar Plexus Catheter (6 Years and Older) | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. |
| OG004 | Patient Controlled Analgesia (6 Years and Older) | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
|
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| Primary | 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) | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Days 0-2 |
|
|
|
| Primary | Total Perioperative Morphine Equivalents | All administered opioids measured as morphine equivalents (mg/kg) | Posted | Mean | Standard Deviation | mg/kg | Post-Operative Days 0-2 |
|
|
|
| Secondary | Nausea | % of patients with nausea | Posted | Number | percentage of participants | Post-Operative Days 0-2 |
|
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|
| Secondary | Itching | % of patients with itching | Posted | Number | percentage of participants | Post-Operative Days 0-2 |
|
|
|
| Secondary | Muscle Spasm | % of patients w/ muscle spasm | Posted | Number | percentage of participants | Post-Operative days 0-2 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Lumbar Plexus Catheter (< 6 Years Old) | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Lumbar Epidural Catheter (6 Years and Older) | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | Lumbar Plexus Catheter (6 Years and Older) | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG004 | Patient Controlled Analgesia (6 Years and Older) | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D000937 | Antigen-Antibody Reactions |
| D055633 | Immune System Phenomena |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D003061 | Codeine |
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| Male |
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