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Post Operative Pain Control After Pediatric Hip Surgery

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ClinicalTrials.gov Identifier: NCT03435692
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Seattle Children's Research Institute Center for Clinical and Translational Research
Information provided by (Responsible Party):
David Liston, Seattle Children's Hospital

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 with intravenous morphine (PCA).

Condition or disease Intervention/treatment Phase
Hip Surgery Post Operative Pain Control Procedure: Lumbar Plexus Catheter Procedure: Lumbar Epidural Catheter Procedure: Patient Controlled Analgesia Drug: Fentanyl Drug: Morphine Drug: Lorazepam Drug: Ondansetron Drug: Diphenhydramine Drug: Acetaminophen Drug: Oxycodone Drug: Ropivacaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial
Actual Study Start Date : July 15, 2011
Actual Primary Completion Date : July 29, 2014
Actual Study Completion Date : July 29, 2014

Resource links provided by the National Library of Medicine


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 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.

Procedure: Lumbar Plexus Catheter
lumbar plexus catheter placed intraoperatively for perioperative pain control
Other Name: LPC

Drug: Fentanyl
IV fentanyl was administered in the OR for induction of anesthesia. Subsequent doses in the OR 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 OR patients, IV 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. IV Morphine was also administered in the OR if the patient was randomized to the PCA arm of the study. Post operatively IV Morphine was administered as needed for severe pain.

Drug: Lorazepam
IV Lorazepam was administered PRN for muscle spasm post operatively.
Other Name: Ativan

Drug: Ondansetron
IV Ondansetron was administered PRN for nausea and vomiting post operatively.
Other Name: Zofran

Drug: Diphenhydramine
IV Diphenhydramine was administered PRN for itching postoperatively.
Other Name: Benadyrl

Drug: Acetaminophen
PO Acetaminophen was administered PRN for pain in the PACU and then scheduled for 72 hours.
Other Name: Tylenol

Drug: Oxycodone
PO Oxycodone was administered PRN for breakthrough pain post operatively.

Drug: Ropivacaine
IV 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 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.

Procedure: Lumbar Epidural Catheter
lumbar epidural catheter placed intraoperatively for perioperative pain control
Other Name: LEC

Drug: Fentanyl
IV fentanyl was administered in the OR for induction of anesthesia. Subsequent doses in the OR 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 OR patients, IV 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. IV Morphine was also administered in the OR if the patient was randomized to the PCA arm of the study. Post operatively IV Morphine was administered as needed for severe pain.

Drug: Lorazepam
IV Lorazepam was administered PRN for muscle spasm post operatively.
Other Name: Ativan

Drug: Ondansetron
IV Ondansetron was administered PRN for nausea and vomiting post operatively.
Other Name: Zofran

Drug: Diphenhydramine
IV Diphenhydramine was administered PRN for itching postoperatively.
Other Name: Benadyrl

Drug: Acetaminophen
PO Acetaminophen was administered PRN for pain in the PACU and then scheduled for 72 hours.
Other Name: Tylenol

Drug: Oxycodone
PO Oxycodone was administered PRN for breakthrough pain post operatively.

Drug: Ropivacaine
IV 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: 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.

Procedure: Patient Controlled Analgesia
A PCA started post operatively for perioperative pain control
Other Name: PCA

Drug: Fentanyl
IV fentanyl was administered in the OR for induction of anesthesia. Subsequent doses in the OR 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 OR patients, IV 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. IV Morphine was also administered in the OR if the patient was randomized to the PCA arm of the study. Post operatively IV Morphine was administered as needed for severe pain.

Drug: Lorazepam
IV Lorazepam was administered PRN for muscle spasm post operatively.
Other Name: Ativan

Drug: Ondansetron
IV Ondansetron was administered PRN for nausea and vomiting post operatively.
Other Name: Zofran

Drug: Diphenhydramine
IV Diphenhydramine was administered PRN for itching postoperatively.
Other Name: Benadyrl

Drug: Acetaminophen
PO Acetaminophen was administered PRN for pain in the PACU and then scheduled for 72 hours.
Other Name: Tylenol

Drug: Oxycodone
PO Oxycodone was administered PRN for breakthrough pain post operatively.




Primary Outcome Measures :
  1. Length of Stay [ Time Frame: Post operative days 0-2 ]
    Hospital length of stay


Secondary Outcome Measures :
  1. Post operative pain: ages 1-3 years [ Time Frame: Post operative day 0-2 ]
    The FLACC (Faces, Legs, Activity, Cry, Consolability) pain intensity rating scale was used to assess post operative pain by the patient's nurse in either the PACU or the floor. The FLACC is a validated behavior pain assessment scale for use in non-verbal patients unable to provide reports of pain. Each of the 5 assessments are given a score from 0-2 for a total pain scale range from 0 to 10.

  2. Post operative pain: ages 3-7 years [ Time Frame: Post operative day 0-2 ]
    The Faces Pain Scale - Revised (FPS-R) was used to assess post operative pain by the patient's nurse in either the PACU or the floor. The Faces Pain Scale - Revised is a validated visual scale of 6 faces that represent different levels of pain (0,2,4,6,8,10). Patients were asked to point to the face that shows how much they hurt for a pain scale range from 0 to 10.

  3. Post operative pain: ages 8 years and older [ Time Frame: Post operative day 0-2 ]
    Numeric Rating Scale was used to assess post operative pain by the patient's nurse in either the PACU or the floor. The Numeric Rating Scale is a validated self reported pain scale range from 0 to 10.

  4. Opioid Consumption [ Time Frame: Post operative day 0-2 ]
    All administered opioids (measured as morphine equivalents / kg / day)

  5. Side Effects [ Time Frame: Post operative day 0-2 ]
    Nausea, muscle spasm, pruritus



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Layout table for eligibility information
Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Publications:
Layout table for additonal information
Responsible Party: David Liston, Assistant Professor, Attending Anesthesiologist, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03435692    
Other Study ID Numbers: 13144
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Diphenhydramine
Promethazine
Fentanyl
Morphine
Oxycodone
Lorazepam
Ondansetron
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Antipyretics
Antiemetics
Autonomic Agents