Hip Surgery, Post Operative Pain Control
Conditions
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.
Interventions
PROCEDURELumbar Plexus Catheter
lumbar plexus catheter placed intraoperatively for perioperative pain control
PROCEDURELumbar Epidural Catheter
lumbar epidural catheter placed intraoperatively for perioperative pain control
PROCEDUREPatient Controlled Analgesia
Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control
DRUGFentanyl
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.
DRUGMorphine
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.
DRUGLorazepam
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
DRUGOndansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
DRUGDiphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
DRUGAcetaminophen
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
DRUGOxycodone
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
DRUGRopivacaine
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.
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 9 |
| 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. | 7 |
| 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. | 9 |
| 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. | 7 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | 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) |
|---|---|---|---|---|---|---|
| Age, Customized 6 to 18 years old 6 to 18 years old | 23 Participants | 0 Participants | 0 Participants | 7 Participants | 9 Participants | 7 Participants |
| Age, Customized < 6 years old | 19 Participants | 10 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants |
| American Society of Anesthesiologists (ASA) Physical Status Classification System American Society of Anesthesiologists (ASA) Physical Status 2 | 17 Participants | 2 Participants | 3 Participants | 3 Participants | 6 Participants | 3 Participants |
| American Society of Anesthesiologists (ASA) Physical Status Classification System American Society of Anesthesiologists (ASA) Physical Status 3 | 4 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants |
| American Society of Anesthesiologists (ASA) Physical Status Classification System American Society of Anesthesiologists (ASA) Physical Status I | 21 Participants | 7 Participants | 6 Participants | 3 Participants | 1 Participants | 4 Participants |
| Diagnosis Femoroacetabular Impingement | 13 Participants | 0 Participants | 0 Participants | 4 Participants | 5 Participants | 4 Participants |
| Diagnosis Hip Dysplasia | 25 Participants | 10 Participants | 9 Participants | 1 Participants | 4 Participants | 1 Participants |
| Diagnosis Other | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — | — |
| Sex: Female, Male Female | 31 Participants | 10 Participants | 8 Participants | 5 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 11 Participants | 0 Participants | 1 Participants | 2 Participants | 6 Participants | 2 Participants |
| Surgical Approach Anterior | 10 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants |
| Surgical Approach Anterior w/ Osteotomy | 19 Participants | 6 Participants | 4 Participants | 2 Participants | 4 Participants | 3 Participants |
| Surgical Approach Lateral w/ Osteotomy | 13 Participants | 2 Participants | 4 Participants | 3 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 | 0 / 7 | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 0 / 10 | 0 / 9 | 0 / 7 | 0 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 | 0 / 7 | 0 / 9 | 0 / 7 |
Outcome results
Primary
Hospital Length of Stay
Total hospital length of stay
Time frame: Through hospital stay, an average of 2-3 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Epidural Catheter (< 6 Years Old) | Hospital Length of Stay | 1.9 days | Standard Deviation 0.5 |
| Lumbar Plexus Catheter (< 6 Years Old) | Hospital Length of Stay | 2 days | Standard Deviation 0.8 |
| Lumbar Epidural Catheter (6 Years and Older) | Hospital Length of Stay | 2.9 days | Standard Deviation 0.8 |
| Lumbar Plexus Catheter (6 Years and Older) | Hospital Length of Stay | 2.5 days | Standard Deviation 1.3 |
| Patient Controlled Analgesia (6 Years and Older) | Hospital Length of Stay | 3.2 days | Standard Deviation 1.1 |
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)
Time frame: Post-Operative Days 0-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Epidural Catheter (< 6 Years Old) | Maximum Pain Score | 5.5 score on a scale | Standard Deviation 0.9 |
| Lumbar Plexus Catheter (< 6 Years Old) | Maximum Pain Score | 4.3 score on a scale | Standard Deviation 1.7 |
| Lumbar Epidural Catheter (6 Years and Older) | Maximum Pain Score | 6.4 score on a scale | Standard Deviation 1.7 |
| Lumbar Plexus Catheter (6 Years and Older) | Maximum Pain Score | 5.5 score on a scale | Standard Deviation 1.1 |
| Patient Controlled Analgesia (6 Years and Older) | Maximum Pain Score | 6.5 score on a scale | Standard Deviation 1.7 |
Primary
Total Perioperative Morphine Equivalents
All administered opioids measured as morphine equivalents (mg/kg)
Time frame: Post-Operative Days 0-2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumbar Epidural Catheter (< 6 Years Old) | Total Perioperative Morphine Equivalents | 0.54 mg/kg | Standard Deviation 0.3 |
| Lumbar Plexus Catheter (< 6 Years Old) | Total Perioperative Morphine Equivalents | 0.7 mg/kg | Standard Deviation 0.4 |
| Lumbar Epidural Catheter (6 Years and Older) | Total Perioperative Morphine Equivalents | 0.85 mg/kg | Standard Deviation 0.4 |
| Lumbar Plexus Catheter (6 Years and Older) | Total Perioperative Morphine Equivalents | 0.83 mg/kg | Standard Deviation 0.3 |
| Patient Controlled Analgesia (6 Years and Older) | Total Perioperative Morphine Equivalents | 2.23 mg/kg | Standard Deviation 1.1 |
Secondary
Itching
% of patients with itching
Time frame: Post-Operative Days 0-2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumbar Epidural Catheter (< 6 Years Old) | Itching | 40 percentage of participants |
| Lumbar Plexus Catheter (< 6 Years Old) | Itching | 33.3 percentage of participants |
| Lumbar Epidural Catheter (6 Years and Older) | Itching | 28.6 percentage of participants |
| Lumbar Plexus Catheter (6 Years and Older) | Itching | 22.2 percentage of participants |
| Patient Controlled Analgesia (6 Years and Older) | Itching | 42.9 percentage of participants |
Secondary
Muscle Spasm
% of patients w/ muscle spasm
Time frame: Post-Operative days 0-2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumbar Epidural Catheter (< 6 Years Old) | Muscle Spasm | 80 percentage of participants |
| Lumbar Plexus Catheter (< 6 Years Old) | Muscle Spasm | 55.6 percentage of participants |
| Lumbar Epidural Catheter (6 Years and Older) | Muscle Spasm | 100 percentage of participants |
| Lumbar Plexus Catheter (6 Years and Older) | Muscle Spasm | 44.4 percentage of participants |
| Patient Controlled Analgesia (6 Years and Older) | Muscle Spasm | 71.4 percentage of participants |
Secondary
Nausea
% of patients with nausea
Time frame: Post-Operative Days 0-2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lumbar Epidural Catheter (< 6 Years Old) | Nausea | 40 percentage of participants |
| Lumbar Plexus Catheter (< 6 Years Old) | Nausea | 33.3 percentage of participants |
| Lumbar Epidural Catheter (6 Years and Older) | Nausea | 71.4 percentage of participants |
| Lumbar Plexus Catheter (6 Years and Older) | Nausea | 55.6 percentage of participants |
| Patient Controlled Analgesia (6 Years and Older) | Nausea | 71.4 percentage of participants |