Post Operative Pain Control After Pediatric Hip Surgery

NCT03435692 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-11-02

Study results available
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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.

Conditions

  • Hip Surgery
  • Post Operative Pain Control

Interventions

PROCEDURE

Lumbar Plexus Catheter

lumbar plexus catheter placed intraoperatively for perioperative pain control

PROCEDURE

Lumbar Epidural Catheter

lumbar epidural catheter placed intraoperatively for perioperative pain control

PROCEDURE

Patient Controlled Analgesia

Patient Controlled Analgesia (PCA) was started post operatively for perioperative pain control

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.

DRUG

Ondansetron

Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.

DRUG

Diphenhydramine

Intravenous Diphenhydramine was administered as needed for itching postoperatively.

DRUG

Acetaminophen

Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.

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.

Sponsors & Collaborators

  • Seattle Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-15
Primary Completion
2014-07-29
Completion
2014-07-29

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03435692 on ClinicalTrials.gov