An interventional study of Lumbar Plexus Catheter and Lumbar Epidural Catheter in Hip Surgery and Post Operative Pain Control, sponsored by Seattle Children's Hospital. Terminated. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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 · Drug: Fentanyl · Drug: Morphine · Drug: Lorazepam · Drug: Ondansetron · Drug: Diphenhydramine · Drug: Acetaminophen · Drug: Oxycodone · Drug: Ropivacaine
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 · Drug: Fentanyl · Drug: Morphine · Drug: Lorazepam · Drug: Ondansetron · Drug: Diphenhydramine · Drug: Acetaminophen · Drug: Oxycodone · Drug: Ropivacaine
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 · Drug: Fentanyl · Drug: Morphine · Drug: Lorazepam · Drug: Ondansetron · Drug: Diphenhydramine · Drug: Acetaminophen · Drug: Oxycodone
lumbar plexus catheter placed intraoperatively for perioperative pain control
Also known as: LPC
lumbar epidural catheter placed intraoperatively for perioperative pain control
Also known as: LEC
Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control
Also known as: PCA
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.
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.
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
Also known as: Ativan
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Also known as: Zofran
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Also known as: Benadryl
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
Also known as: Tylenol
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
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.
Hospital Length of Stay
Total hospital length of stay
Time frame: 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)
Time frame: Post-Operative Days 0-2
Total Perioperative Morphine Equivalents
All administered opioids measured as morphine equivalents (mg/kg)
Time frame: Post-Operative Days 0-2
Nausea
% of patients with nausea
Time frame: Post-Operative Days 0-2
Itching
% of patients with itching
Time frame: Post-Operative Days 0-2
Muscle Spasm
% of patients w/ muscle spasm
Time frame: Post-Operative days 0-2
All patients were recruited at Seattle Children's Hospital main campus location. Recruitment period ran from 7/15/11 to 7/29/14.
| Milestone | Lumbar Epidural Catheter | Lumbar Plexus Catheter | Patient Controlled Analgesia |
|---|---|---|---|
| Started | 17 | 18 | 7 |
| Completed | 15 | 16 | 7 |
| Not completed | 2 | 2 | 0 |
| Withdrew: Lack of efficacy | 2 | 2 | 0 |
Total hospital length of stay
| days | 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) |
|---|---|---|---|---|---|
| Hospital Length of Stay | 1.9 ± 0.5 | 2 ± 0.8 | 2.9 ± 0.8 | 2.5 ± 1.3 | 3.2 ± 1.1 |
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)
| score on a scale | 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) |
|---|---|---|---|---|---|
| Maximum Pain Score | 5.5 ± 0.9 | 4.3 ± 1.7 | 6.4 ± 1.7 | 5.5 ± 1.1 | 6.5 ± 1.7 |
All administered opioids measured as morphine equivalents (mg/kg)
| mg/kg | 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 Perioperative Morphine Equivalents | 0.54 ± 0.3 | 0.7 ± 0.4 | 0.85 ± 0.4 | 0.83 ± 0.3 | 2.23 ± 1.1 |
% of patients with nausea
| percentage of participants | 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) |
|---|---|---|---|---|---|
| Nausea | 40 | 33.3 | 71.4 | 55.6 | 71.4 |
% of patients with itching
| percentage of participants | 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) |
|---|---|---|---|---|---|
| Itching | 40 | 33.3 | 28.6 | 22.2 | 42.9 |
% of patients w/ muscle spasm
| percentage of participants | 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) |
|---|---|---|---|---|---|
| Muscle Spasm | 80 | 55.6 | 100 | 44.4 | 71.4 |
Collected over Up to 5 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lumbar Epidural Catheter (< 6 Years Old) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Lumbar Plexus Catheter (< 6 Years Old) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Lumbar Epidural Catheter (6 Years and Older) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Lumbar Plexus Catheter (6 Years and Older) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Patient Controlled Analgesia (6 Years and Older) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Customized(Participants) | 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 |
|---|---|---|---|---|---|---|
| < 6 years old | 10 | 9 | 0 | 0 | 0 | 19 |
| 6 to 18 years old 6 to 18 years old | 0 | 0 | 7 | 9 | 7 | 23 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|
| Female | 10 | 8 | 5 | 3 | 5 | 31 |
| Male | 0 | 1 | 2 | 6 | 2 | 11 |
| Race and Ethnicity Not Collected(Participants) | 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 |
|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | 0 |
| American Society of Anesthesiologists (ASA) Physical Status Classification System(Participants) | 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 |
|---|---|---|---|---|---|---|
| American Society of Anesthesiologists (ASA) Physical Status I | 7 | 6 | 3 | 1 | 4 | 21 |
| American Society of Anesthesiologists (ASA) Physical Status 2 | 2 | 3 | 3 | 6 | 3 | 17 |
| American Society of Anesthesiologists (ASA) Physical Status 3 | 1 | 0 | 1 | 2 | 0 | 4 |
| Surgical Approach(Participants) | 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 |
|---|---|---|---|---|---|---|
| Anterior w/ Osteotomy | 6 | 4 | 2 | 4 | 3 | 19 |
| Anterior | 2 | 1 | 2 | 4 | 1 | 10 |
| Lateral w/ Osteotomy | 2 | 4 | 3 | 1 | 3 | 13 |
| Diagnosis(Participants) | 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 |
|---|---|---|---|---|---|---|
| Femoroacetabular Impingement | 0 | 0 | 4 | 5 | 4 | 13 |
| Hip Dysplasia | 10 | 9 | 1 | 4 | 1 | 25 |
| Other | 0 | 0 | 2 | 0 | 2 | 4 |
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