Post Operative Pain Control After Pediatric Hip Surgery

NCT03435692 | Terminated Results

• 1 other identifier: 13144
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Surgery; Post Operative Pain Control

Outcome Measures

Primary Outcomes (3)

• Hospital Length of Stay

  Total hospital length of stay

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

• 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)

  Post-Operative Days 0-2

• Total Perioperative Morphine Equivalents

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

  Post-Operative Days 0-2

Secondary Outcomes (3)

• Nausea

  Post-Operative Days 0-2

• Itching

  Post-Operative Days 0-2

• Muscle Spasm

  Post-Operative days 0-2

Study Arms (3)

Lumbar Plexus Catheter

EXPERIMENTAL

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; Drug: Fentanyl; Drug: Morphine; Drug: Lorazepam; Drug: Ondansetron; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Oxycodone; Drug: Ropivacaine

Lumbar Epidural Catheter

ACTIVE COMPARATOR

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.

Procedure: Lumbar Epidural Catheter; Drug: Fentanyl; Drug: Morphine; Drug: Lorazepam; Drug: Ondansetron; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Oxycodone; Drug: Ropivacaine

Patient Controlled Analgesia

ACTIVE COMPARATOR

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.

Procedure: Patient Controlled Analgesia; Drug: Fentanyl; Drug: Morphine; Drug: Lorazepam; Drug: Ondansetron; Drug: Diphenhydramine; Drug: Acetaminophen; Drug: Oxycodone

Interventions

Lumbar Plexus Catheter PROCEDURE

lumbar plexus catheter placed intraoperatively for perioperative pain control

Also known as: LPC

Lumbar Plexus Catheter

Lumbar Epidural Catheter PROCEDURE

lumbar epidural catheter placed intraoperatively for perioperative pain control

Also known as: LEC

Lumbar Epidural Catheter

Patient Controlled Analgesia PROCEDURE

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

Also known as: PCA

Patient Controlled Analgesia

Fentanyl DRUG

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.

Lumbar Epidural Catheter; Lumbar Plexus Catheter; Patient Controlled Analgesia

Morphine DRUG

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.

Lumbar Epidural Catheter; Lumbar Plexus Catheter; Patient Controlled Analgesia

Lorazepam DRUG

Intravenous Lorazepam was administered as needed for muscle spasm post operatively.

Also known as: Ativan

Lumbar Epidural Catheter; Lumbar Plexus Catheter; Patient Controlled Analgesia

Ondansetron DRUG

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

Also known as: Zofran

Lumbar Epidural Catheter; Lumbar Plexus Catheter; Patient Controlled Analgesia

Diphenhydramine DRUG

Intravenous Diphenhydramine was administered as needed for itching postoperatively.

Also known as: Benadryl

Lumbar Epidural Catheter; Lumbar Plexus Catheter; Patient Controlled Analgesia

Acetaminophen DRUG

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

Also known as: Tylenol

Lumbar Epidural Catheter; Lumbar Plexus Catheter; Patient Controlled Analgesia

Oxycodone DRUG

Oral Oxycodone was administered as needed for breakthrough pain post operatively.

Lumbar Epidural Catheter; Lumbar Plexus Catheter; Patient Controlled Analgesia

Ropivacaine DRUG

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.

Lumbar Epidural Catheter; Lumbar Plexus Catheter

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Related Publications (5)

• Tredwell SJ. Neonatal screening for hip joint instability. Its clinical and economic relevance. Clin Orthop Relat Res. 1992 Aug;(281):63-8.

  PMID: 1499229 BACKGROUND

• Horlocker TT, Kopp SL, Pagnano MW, Hebl JR. Analgesia for total hip and knee arthroplasty: a multimodal pathway featuring peripheral nerve block. J Am Acad Orthop Surg. 2006 Mar;14(3):126-35. doi: 10.5435/00124635-200603000-00003.

  PMID: 16520363 BACKGROUND

• Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;2003(3):CD003071. doi: 10.1002/14651858.CD003071.

  PMID: 12917945 BACKGROUND

• Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.

  PMID: 19122076 BACKGROUND

• Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.

  PMID: 14612482 BACKGROUND

MeSH Terms

Interventions

Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Fentanyl; Morphine; Lorazepam; Ondansetron; Diphenhydramine; Acetaminophen; Oxycodone; Ropivacaine

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Codeine

Limitations and Caveats

This study was terminated early because funding was exhausted prior to enrolling intended number of patients. Based on the pre study power analysis we planned to recruit 75 patients; however, we were only able to enroll 42 patients due to limited funding.

Results Point of Contact

• Title: David E. Liston, MD, MPH
• Organization: Seattle Children's Hospital

david.liston@seattlechildrens.org

206-987-3996

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Attending Anesthesiologist

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 19, 2018
• Study Start: July 15, 2011
• Primary Completion: July 29, 2014
• Study Completion: July 29, 2014
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share