Post Operative Pain Control After Pediatric Hip Surgery

Hip Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03435692
• Other study ID #: 13144
• Status: Terminated
• Phase: N/A
• Start date: July 15, 2011
• Est. completion date: July 29, 2014

Study information

• Verified date: October 2021
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: July 29, 2014
• Est. primary completion date: July 29, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Surgery
• Pain, Postoperative
• Post Operative Pain Control

Intervention

Procedure:
• Lumbar Plexus Catheter
lumbar plexus catheter placed intraoperatively for perioperative pain control
• Lumbar Epidural Catheter
lumbar epidural catheter placed intraoperatively for perioperative pain control
• 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.
• 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.
• Lorazepam
Intravenous Lorazepam was administered as needed for muscle spasm post operatively.
• Ondansetron
Intravenous Ondansetron was administered as needed for nausea and vomiting post operatively.
• Diphenhydramine
Intravenous Diphenhydramine was administered as needed for itching postoperatively.
• Acetaminophen
Oral Acetaminophen was administered as needed for pain in the Post-Anesthesia Care Unit (PACU) and then scheduled for 72 hours.
• Oxycodone
Oral Oxycodone was administered as needed for breakthrough pain post operatively.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Seattle Children's Research Institute Center for Clinical and Translational Research

References & Publications (5)

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. Review. — View Citation

Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;(3):CD003071. Review. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	Total hospital length of stay	Through hospital stay, an average of 2-3 days.
Primary	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
Primary	Total Perioperative Morphine Equivalents	All administered opioids measured as morphine equivalents (mg/kg)	Post-Operative Days 0-2
Secondary	Nausea	% of patients with nausea	Post-Operative Days 0-2
Secondary	Itching	% of patients with itching	Post-Operative Days 0-2
Secondary	Muscle Spasm	% of patients w/ muscle spasm	Post-Operative days 0-2