Clinical trial NCT06701695: Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty
Official title: Efficacy of Intraoperative Periarticular Injections in Reducing Blood Loss and Transfusion Requirements in Hip Fracture Hemiarthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Hemiarthroplasty
Blood Loss Requiring Transfusion
Keywords: Hip Fracture
Hemiarthroplasty
Periarticular injection
Blood loss
Blood transfusion requirement
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 84
Sex: ALL
Minimum age (years): 58
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups were established, one serving as the control group receiving standard hemiarthroplasty treatment.
Primary purpose: TREATMENT

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?

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of femoral neck fracture

Exclusion Criteria:

* Anti-aggregant, anti-coagulant or anti-thrombotic therapy
* Pathological fractures, periprosthetic fractures, or revision procedures
* Intolerance or allergy to the medications utilized in the study
* Refused to participation

Primary outcomes:
measure: Total Blood Loss
timeFrame: Preoperative and postoperative hematocrit (HCT) and hemoglobin (Hb) levels measured over the first three days
Secondary outcomes:
measure: Hidden Blood Loss
timeFrame: Postoperative first three days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
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