Trial Outcomes & Findings for Post Operative Pain Control After Pediatric Hip Surgery (NCT NCT03435692)

NCT ID: NCT03435692

Last Updated: 2021-11-02

Results Overview

Total hospital length of stay

Recruitment status

TERMINATED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

Through hospital stay, an average of 2-3 days.

Results posted on

2021-11-02

Participant Flow

All patients were recruited at Seattle Children's Hospital main campus location. Recruitment period ran from 7/15/11 to 7/29/14.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	18	7	17
Overall Study COMPLETED	16	7	15
Overall Study NOT COMPLETED	2	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Lack of Efficacy	2	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumbar Epidural Catheter (< 6 Years Old) n=10 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (< 6 Years Old) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Epidural Catheter (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (6 Years and Older) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Patient Controlled Analgesia (6 Years and Older) n=7 Participants 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 n=42 Participants Total of all reporting groups
Age, Customized < 6 years old	10 Participants n=10 Participants	9 Participants n=9 Participants	0 Participants n=7 Participants	0 Participants n=9 Participants	0 Participants n=7 Participants	19 Participants n=42 Participants
Age, Customized 6 to 18 years old 6 to 18 years old	0 Participants n=10 Participants	0 Participants n=9 Participants	7 Participants n=7 Participants	9 Participants n=9 Participants	7 Participants n=7 Participants	23 Participants n=42 Participants
Sex: Female, Male Female	10 Participants n=10 Participants	8 Participants n=9 Participants	5 Participants n=7 Participants	3 Participants n=9 Participants	5 Participants n=7 Participants	31 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	1 Participants n=9 Participants	2 Participants n=7 Participants	6 Participants n=9 Participants	2 Participants n=7 Participants	11 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
American Society of Anesthesiologists (ASA) Physical Status Classification System American Society of Anesthesiologists (ASA) Physical Status I	7 Participants n=10 Participants	6 Participants n=9 Participants	3 Participants n=7 Participants	1 Participants n=9 Participants	4 Participants n=7 Participants	21 Participants n=42 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System American Society of Anesthesiologists (ASA) Physical Status 2	2 Participants n=10 Participants	3 Participants n=9 Participants	3 Participants n=7 Participants	6 Participants n=9 Participants	3 Participants n=7 Participants	17 Participants n=42 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System American Society of Anesthesiologists (ASA) Physical Status 3	1 Participants n=10 Participants	0 Participants n=9 Participants	1 Participants n=7 Participants	2 Participants n=9 Participants	0 Participants n=7 Participants	4 Participants n=42 Participants
Surgical Approach Anterior w/ Osteotomy	6 Participants n=10 Participants	4 Participants n=9 Participants	2 Participants n=7 Participants	4 Participants n=9 Participants	3 Participants n=7 Participants	19 Participants n=42 Participants
Surgical Approach Anterior	2 Participants n=10 Participants	1 Participants n=9 Participants	2 Participants n=7 Participants	4 Participants n=9 Participants	1 Participants n=7 Participants	10 Participants n=42 Participants
Surgical Approach Lateral w/ Osteotomy	2 Participants n=10 Participants	4 Participants n=9 Participants	3 Participants n=7 Participants	1 Participants n=9 Participants	3 Participants n=7 Participants	13 Participants n=42 Participants
Diagnosis Femoroacetabular Impingement	0 Participants n=10 Participants	0 Participants n=9 Participants	4 Participants n=7 Participants	5 Participants n=9 Participants	4 Participants n=7 Participants	13 Participants n=42 Participants
Diagnosis Hip Dysplasia	10 Participants n=10 Participants	9 Participants n=9 Participants	1 Participants n=7 Participants	4 Participants n=9 Participants	1 Participants n=7 Participants	25 Participants n=42 Participants
Diagnosis Other	0 Participants n=10 Participants	0 Participants n=9 Participants	2 Participants n=7 Participants	0 Participants n=9 Participants	2 Participants n=7 Participants	4 Participants n=42 Participants

PRIMARY outcome

Timeframe: Through hospital stay, an average of 2-3 days.

Total hospital length of stay

Outcome measures

Outcome measures
Measure	Lumbar Epidural Catheter (< 6 Years Old) n=10 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (< 6 Years Old) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Epidural Catheter (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (6 Years and Older) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Patient Controlled Analgesia (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
Hospital Length of Stay	1.9 days Standard Deviation 0.5	2 days Standard Deviation 0.8	2.9 days Standard Deviation 0.8	2.5 days Standard Deviation 1.3	3.2 days Standard Deviation 1.1

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Lumbar Epidural Catheter (< 6 Years Old) n=10 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (< 6 Years Old) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Epidural Catheter (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (6 Years and Older) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Patient Controlled Analgesia (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
Maximum Pain Score	5.5 score on a scale Standard Deviation 0.9	4.3 score on a scale Standard Deviation 1.7	6.4 score on a scale Standard Deviation 1.7	5.5 score on a scale Standard Deviation 1.1	6.5 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Post-Operative Days 0-2

All administered opioids measured as morphine equivalents (mg/kg)

Outcome measures

Outcome measures
Measure	Lumbar Epidural Catheter (< 6 Years Old) n=10 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (< 6 Years Old) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Epidural Catheter (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (6 Years and Older) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Patient Controlled Analgesia (6 Years and Older) n=7 Participants 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 Perioperative Morphine Equivalents	0.54 mg/kg Standard Deviation 0.3	0.7 mg/kg Standard Deviation 0.4	0.85 mg/kg Standard Deviation 0.4	0.83 mg/kg Standard Deviation 0.3	2.23 mg/kg Standard Deviation 1.1

SECONDARY outcome

Timeframe: Post-Operative Days 0-2

% of patients with nausea

Outcome measures

Outcome measures
Measure	Lumbar Epidural Catheter (< 6 Years Old) n=10 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (< 6 Years Old) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Epidural Catheter (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (6 Years and Older) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Patient Controlled Analgesia (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
Nausea	40 percentage of participants	33.3 percentage of participants	71.4 percentage of participants	55.6 percentage of participants	71.4 percentage of participants

SECONDARY outcome

Timeframe: Post-Operative Days 0-2

% of patients with itching

Outcome measures

Outcome measures
Measure	Lumbar Epidural Catheter (< 6 Years Old) n=10 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (< 6 Years Old) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Epidural Catheter (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have an epidural catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Lumbar Plexus Catheter (6 Years and Older) n=9 Participants Children undergoing pediatric hip surgery will have a lumbar plexus catheter placed (with bolus and continuous infusion of ropivacaine) intraoperatively for perioperative pain control.	Patient Controlled Analgesia (6 Years and Older) n=7 Participants Children undergoing pediatric hip surgery will have patient controlled analgesia (with morphine) started in the post anesthesia care unit for post operative pain control.
Itching	40 percentage of participants	33.3 percentage of participants	28.6 percentage of participants	22.2 percentage of participants	42.9 percentage of participants

SECONDARY outcome

Timeframe: Post-Operative days 0-2

% of patients w/ muscle spasm