Post Operative Pain Control After Pediatric Hip Surgery

October 4, 2021 updated by: David Liston, Seattle Children's Hospital

Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • LPC
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:
  • Ativan
Drug: Ondansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Other Names:
  • Zofran
Drug: Diphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Other Names:
  • Benadryl
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:
  • Tylenol
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.
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:
  • Ativan
Drug: Ondansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Other Names:
  • Zofran
Drug: Diphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Other Names:
  • Benadryl
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:
  • Tylenol
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.
Procedure: Lumbar Epidural Catheter
lumbar epidural catheter placed intraoperatively for perioperative pain control
Other Names:
  • LEC
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.
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:
  • Ativan
Drug: Ondansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
Other Names:
  • Zofran
Drug: Diphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
Other Names:
  • Benadryl
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:
  • Tylenol
Drug: Oxycodone
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
Procedure: Patient Controlled Analgesia
Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control
Other Names:
  • PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: Through hospital stay, an average of 2-3 days.
Total hospital length of stay
Through hospital stay, an average of 2-3 days.
Maximum Pain Score
Time Frame: 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)
Post-Operative Days 0-2
Total Perioperative Morphine Equivalents
Time Frame: Post-Operative Days 0-2
All administered opioids measured as morphine equivalents (mg/kg)
Post-Operative Days 0-2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea
Time Frame: Post-Operative Days 0-2
% of patients with nausea
Post-Operative Days 0-2
Itching
Time Frame: Post-Operative Days 0-2
% of patients with itching
Post-Operative Days 0-2
Muscle Spasm
Time Frame: Post-Operative days 0-2
% of patients w/ muscle spasm
Post-Operative days 0-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

Seattle Children's Research Institute Center for Clinical and Translational Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2011

Primary Completion (Actual)

July 29, 2014

Study Completion (Actual)

July 29, 2014

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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