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Completed

NCT Number: NCT06701695

Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty

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.

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Key information

Age range

58 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06560, Turkey (Türkiye)

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Periarticular Injection (PAI)

Procedure

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 prior to 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.

Control (Standard treatment)

Procedure

The control group received the conventional treatment protocol.

Primary outcomes

  1. Total Blood Loss

    Time frame: Preoperative and postoperative hematocrit (HCT) and hemoglobin (Hb) levels measured over the first three days

    The calculation of Total Blood Volume (TBV) was conducted using the following manner:

    TBV= k1 x H3 + k2 x W+ k3 For males, k1 = 0.3669, k2 = 0.03219, and k3 = 0.1833; for females, k1 = 0.3561, k2 = 0.03308, and k3 = 0.1833; H=height (m) and W=weight (kg)

    The calculation of Total blood loss (TBL) was conducted using the Gross formula method as follows:

    TBL= TBV x (Preoperative HCT (Hematocrit) - Postoperative 3-day HCT) / Mean HCT

Secondary outcomes

  1. Hidden Blood Loss

    Time frame: Postoperative first three days

    Intraoperative Blood Loss (IBL) was determined through anesthesia recordings during the operation, which included measuring blood suction bottles and the weight of surgical swabs.

    Visible Blood Loss = Intraoperative Blood Loss + Postoperative suction drain volume The Total Hidden Blood Loss (HBL) volume was determined by deducting the visible blood loss volume from the TBL volume.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Efficacy of Intraoperative Periarticular Injections in Reducing Blood Loss and Transfusion Requirements in Hip Fracture Hemiarthroplasty: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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