Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty

Ankara City Hospital

Status: Completed

Conditions: Blood Loss Requiring Transfusion; Hemiarthroplasty; Femoral Neck Fractures

Treatments: Procedure: Periarticular Injection (PAI); Procedure: Control (Standard treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT06701695

AnkaraCHBilkent-ORT-TK-01

Details and patient eligibility

About

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.

Full 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?

Enrollment: 84 patients

Sex: All

Ages: 58 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Periarticular injection group

Active Comparator group

Description:

Patients in the periarticular injection group were administered a 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.

Treatment:

Procedure: Control (Standard treatment)

Procedure: Periarticular Injection (PAI)

Control group

Sham Comparator group

Description:

Participants in the control group underwent standard hemiarthroplasty treatment, with no administration of periarticular injections.

Treatment:

Procedure: Control (Standard treatment)