MedDataX Logo

Post Operative Pain Control After Pediatric Hip Surgery

NCT ID: NCT03435692

Last Updated: 2021-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-15

Study Completion Date

2014-07-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Surgery Post Operative Pain Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Lumbar Plexus Catheter

Intervention Type PROCEDURE

lumbar plexus catheter placed intraoperatively for perioperative pain control

Fentanyl

Intervention Type 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.

Morphine

Intervention Type 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.

Lorazepam

Intervention Type DRUG

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

Ondansetron

Intervention Type DRUG

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

Diphenhydramine

Intervention Type DRUG

Intravenous Diphenhydramine was administered as needed for itching postoperatively.

Acetaminophen

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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

Ropivacaine

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Lumbar Epidural Catheter

Intervention Type PROCEDURE

lumbar epidural catheter placed intraoperatively for perioperative pain control

Fentanyl

Intervention Type 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.

Morphine

Intervention Type 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.

Lorazepam

Intervention Type DRUG

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

Ondansetron

Intervention Type DRUG

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

Diphenhydramine

Intervention Type DRUG

Intravenous Diphenhydramine was administered as needed for itching postoperatively.

Acetaminophen

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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

Ropivacaine

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Patient Controlled Analgesia

Intervention Type PROCEDURE

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

Fentanyl

Intervention Type 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.

Morphine

Intervention Type 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.

Lorazepam

Intervention Type DRUG

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

Ondansetron

Intervention Type DRUG

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

Diphenhydramine

Intervention Type DRUG

Intravenous Diphenhydramine was administered as needed for itching postoperatively.

Acetaminophen

Intervention Type DRUG

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

Oxycodone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lumbar Plexus Catheter

lumbar plexus catheter placed intraoperatively for perioperative pain control

Intervention Type PROCEDURE

Lumbar Epidural Catheter

lumbar epidural catheter placed intraoperatively for perioperative pain control

Intervention Type PROCEDURE

Patient Controlled Analgesia

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

Intervention Type PROCEDURE

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.

Intervention Type 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.

Intervention Type DRUG

Lorazepam

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

Intervention Type DRUG

Ondansetron

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

Intervention Type DRUG

Diphenhydramine

Intravenous Diphenhydramine was administered as needed for itching postoperatively.

Intervention Type DRUG

Acetaminophen

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

Intervention Type DRUG

Oxycodone

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LPC LEC PCA Ativan Zofran Benadryl Tylenol

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Liston

Assistant Professor, Attending Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND
PMID: 1499229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16520363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12917945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19122076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14612482 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13144

Identifier Type: -

Identifier Source: org_study_id