Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT06701695
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2024-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
Efficacy of Intraoperative Periarticular Injections in Reducing Blood Loss and Transfusion Requirements in Hip Fracture Hemiarthroplasty: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study was to assess the effectiveness of the intraoperative periarticular solution in reducing blood loss and minimizing transfusion requirements in patients with femoral neck fractures who underwent hemiarthroplasty.
Detailed Description:
Hip fractures in the elderly represent a significant public health challenge, marked by elevated rates of morbidity and mortality. The worldwide increase in life expectancy has led to a corresponding rise in the incidence of hip fractures. Notably, increased perioperative blood loss has been identified as a critical factor that heightens the risk of complications and mortality. Consequently, contemporary research efforts have focused on addressing this pivotal issue. Various strategies have been developed, including controlled hypotensive anesthesia and the utilization of pharmacological agents aimed at reducing the perioperative blood products. The necessity for the efficacy of tranexamic acid (TXA) in mitigating blood loss has been well-established across numerous surgical specialties. This study is motivated by the need for an effective and safe approach to perioperative blood salvage. To date, there appears to be a lack of research examining the effectiveness of the intraoperative periarticular injection technique (100 mL periarticular solution comprising 200 mg of bupivacaine (40 mL), 60 mg of ketorolac (2 mL), 8 mg of dexamethasone (2 mL), 2 mg of 1:1000 epinephrine (2 mL), and standard saline solution (54 mL). This solution was prepared in two 50 mL syringes. The first syringe containing 50 mL of the cocktail was injected into the capsule and gluteal muscles before femoral stem insertion. Following joint capsule closure, the second syringe containing 50 mL of the periarticular injection cocktail was infiltrated into the fascia lata muscle, subcutaneous tissue, and wound layers) regarding blood loss reduction. Therefore, this study aims to investigate the following questions: 1) Is intraoperative periarticular injection an effective technique for minimizing blood loss in patients with hip fractures? and 2) What proportion of the salvaged blood loss can be attributed to hidden blood loss?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: