Post Operative Pain Control After Pediatric Hip Surgery
Sponsor
Seattle Children's Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03435692
Collaborator
Seattle Children's Research Institute Center for Clinical and Translational Research (Other)
42
3
36.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Type:
Interventional
Actual Enrollment
:
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial
Actual Study Start Date
:
Jul 15, 2011
Actual Primary Completion Date
:
Jul 29, 2014
Actual Study Completion Date
:
Jul 29, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 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. |
Procedure: Lumbar Plexus Catheter
lumbar plexus catheter placed intraoperatively for perioperative pain control
Other Names:
Drug: Fentanyl
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.
Drug: Morphine
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.
Drug: Lorazepam
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
Other Names:
Drug: Ondansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Other Names:
Drug: Diphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Other Names:
Drug: Acetaminophen
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
Other Names:
Drug: Oxycodone
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
Drug: Ropivacaine
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.
|
| Active Comparator: 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 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. |
Procedure: Lumbar Epidural Catheter
lumbar epidural catheter placed intraoperatively for perioperative pain control
Other Names:
Drug: Fentanyl
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.
Drug: Morphine
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.
Drug: Lorazepam
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
Other Names:
Drug: Ondansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Other Names:
Drug: Diphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Other Names:
Drug: Acetaminophen
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
Other Names:
Drug: Oxycodone
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
Drug: Ropivacaine
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.
|
| Active Comparator: 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 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. |
Procedure: Patient Controlled Analgesia
Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control
Other Names:
Drug: Fentanyl
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.
Drug: Morphine
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.
Drug: Lorazepam
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
Other Names:
Drug: Ondansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Other Names:
Drug: Diphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Other Names:
Drug: Acetaminophen
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
Other Names:
Drug: Oxycodone
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
|
Outcome Measures
Primary Outcome Measures
- Hospital Length of Stay [Through hospital stay, an average of 2-3 days.]
Total hospital length of stay
- Maximum Pain Score [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 [Post-Operative Days 0-2]
All administered opioids measured as morphine equivalents (mg/kg)
Secondary Outcome Measures
- Nausea [Post-Operative Days 0-2]
% of patients with nausea
- Itching [Post-Operative Days 0-2]
% of patients with itching
- Muscle Spasm [Post-Operative days 0-2]
% of patients w/ muscle spasm
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Seattle Children's Hospital
- Seattle Children's Research Institute Center for Clinical and Translational Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- 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.
- 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.
- Tredwell SJ. Neonatal screening for hip joint instability. Its clinical and economic relevance. Clin Orthop Relat Res. 1992 Aug;(281):63-8. Review.
Responsible Party:
David Liston,
Assistant Professor, Attending Anesthesiologist,
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT03435692
Other Study ID Numbers:
- 13144
First Posted:
Feb 19, 2018
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | All patients were recruited at Seattle Children's Hospital main campus location. Recruitment period ran from 7/15/11 to 7/29/14. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Lumbar Epidural Catheter | Lumbar Plexus Catheter | Patient Controlled Analgesia |
|---|---|---|---|
| Arm/Group 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 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. | 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. | 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. |
| Period Title: Overall Study | |||
| STARTED | 17 | 18 | 7 |
| COMPLETED | 15 | 16 | 7 |
| NOT COMPLETED | 2 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. | Total of all reporting groups |
| Overall Participants | 10 | 9 | 7 | 9 | 7 | 42 |
| Age, Customized (Count of Participants) | ||||||
| < 6 years old |
10
100%
|
9
100%
|
0
0%
|
0
0%
|
0
0%
|
19
45.2%
|
| 6 to 18 years old 6 to 18 years old |
0
0%
|
0
0%
|
7
100%
|
9
100%
|
7
100%
|
23
54.8%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
10
100%
|
8
88.9%
|
5
71.4%
|
3
33.3%
|
5
71.4%
|
31
73.8%
|
| Male |
0
0%
|
1
11.1%
|
2
28.6%
|
6
66.7%
|
2
28.6%
|
11
26.2%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||||
| Count of Participants [Participants] |
0
0%
|
|||||
| American Society of Anesthesiologists (ASA) Physical Status Classification System (Count of Participants) | ||||||
| American Society of Anesthesiologists (ASA) Physical Status I |
7
70%
|
6
66.7%
|
3
42.9%
|
1
11.1%
|
4
57.1%
|
21
50%
|
| American Society of Anesthesiologists (ASA) Physical Status 2 |
2
20%
|
3
33.3%
|
3
42.9%
|
6
66.7%
|
3
42.9%
|
17
40.5%
|
| American Society of Anesthesiologists (ASA) Physical Status 3 |
1
10%
|
0
0%
|
1
14.3%
|
2
22.2%
|
0
0%
|
4
9.5%
|
| Surgical Approach (Count of Participants) | ||||||
| Anterior w/ Osteotomy |
6
60%
|
4
44.4%
|
2
28.6%
|
4
44.4%
|
3
42.9%
|
19
45.2%
|
| Anterior |
2
20%
|
1
11.1%
|
2
28.6%
|
4
44.4%
|
1
14.3%
|
10
23.8%
|
| Lateral w/ Osteotomy |
2
20%
|
4
44.4%
|
3
42.9%
|
1
11.1%
|
3
42.9%
|
13
31%
|
| Diagnosis (Count of Participants) | ||||||
| Femoroacetabular Impingement |
0
0%
|
0
0%
|
4
57.1%
|
5
55.6%
|
4
57.1%
|
13
31%
|
| Hip Dysplasia |
10
100%
|
9
100%
|
1
14.3%
|
4
44.4%
|
1
14.3%
|
25
59.5%
|
| Other |
0
0%
|
0
0%
|
2
28.6%
|
0
0%
|
2
28.6%
|
4
9.5%
|
Outcome Measures
| Title | Hospital Length of Stay |
|---|---|
| Description | Total hospital length of stay |
| Time Frame | Through hospital stay, an average of 2-3 days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) |
|---|---|---|---|---|---|
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
| Measure Participants | 10 | 9 | 7 | 9 | 7 |
| Mean (Standard Deviation) [days] |
1.9
(0.5)
|
2
(0.8)
|
2.9
(0.8)
|
2.5
(1.3)
|
3.2
(1.1)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) |
|---|---|---|---|---|---|
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
| Measure Participants | 10 | 9 | 7 | 9 | 7 |
| Mean (Standard Deviation) [score on a scale] |
5.5
(0.9)
|
4.3
(1.7)
|
6.4
(1.7)
|
5.5
(1.1)
|
6.5
(1.7)
|
| Title | Total Perioperative Morphine Equivalents |
|---|---|
| Description | All administered opioids measured as morphine equivalents (mg/kg) |
| Time Frame | Post-Operative Days 0-2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) |
|---|---|---|---|---|---|
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
| Measure Participants | 10 | 9 | 7 | 9 | 7 |
| Mean (Standard Deviation) [mg/kg] |
0.54
(0.3)
|
0.7
(0.4)
|
0.85
(0.4)
|
0.83
(0.3)
|
2.23
(1.1)
|
| Title | Nausea |
|---|---|
| Description | % of patients with nausea |
| Time Frame | Post-Operative Days 0-2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) |
|---|---|---|---|---|---|
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
| Measure Participants | 10 | 9 | 7 | 9 | 7 |
| Number [percentage of participants] |
40
400%
|
33.3
370%
|
71.4
1020%
|
55.6
617.8%
|
71.4
1020%
|
| Title | Itching |
|---|---|
| Description | % of patients with itching |
| Time Frame | Post-Operative Days 0-2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) |
|---|---|---|---|---|---|
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
| Measure Participants | 10 | 9 | 7 | 9 | 7 |
| Number [percentage of participants] |
40
400%
|
33.3
370%
|
28.6
408.6%
|
22.2
246.7%
|
42.9
612.9%
|
| Title | Muscle Spasm |
|---|---|
| Description | % of patients w/ muscle spasm |
| Time Frame | Post-Operative days 0-2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) |
|---|---|---|---|---|---|
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. |
| Measure Participants | 10 | 9 | 7 | 9 | 7 |
| Number [percentage of participants] |
80
800%
|
55.6
617.8%
|
100
1428.6%
|
44.4
493.3%
|
71.4
1020%
|
Adverse Events
| Time Frame | Up to 5 days | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||||||
| Arm/Group Title | Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) | |||||
| Arm/Group Description | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control. | Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control. | |||||
All Cause Mortality |
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| Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/9 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | |||||
Serious Adverse Events |
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| Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/9 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | |||||
Other (Not Including Serious) Adverse Events |
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| Lumbar Epidural Catheter (< 6 Years Old) | Lumbar Plexus Catheter (< 6 Years Old) | Lumbar Epidural Catheter (6 Years and Older) | Lumbar Plexus Catheter (6 Years and Older) | Patient Controlled Analgesia (6 Years and Older) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/9 (0%) | 0/7 (0%) | 0/9 (0%) | 0/7 (0%) | |||||
Limitations/Caveats
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.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | David E. Liston, MD, MPH |
|---|---|
| Organization | Seattle Children's Hospital |
| Phone | 206-987-3996 |
| david.liston@seattlechildrens.org |
Responsible Party:
David Liston,
Assistant Professor, Attending Anesthesiologist,
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT03435692
Other Study ID Numbers:
- 13144
First Posted:
Feb 19, 2018
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021