Hip Surgery Clinical Trial
Official title:
Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial
NCT number | NCT03435692 |
Other study ID # | 13144 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | July 15, 2011 |
Est. completion date | July 29, 2014 |
Verified date | October 2021 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Seattle Children's Research Institute Center for Clinical and Translational Research |
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
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 |
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