Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty

November 21, 2024 updated by: TANER KARLIDAĞ, Ankara City Hospital Bilkent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Periarticular injection group
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.
Procedure: Periarticular Injection (PAI)
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.
Procedure: Control (Standard treatment)
The control group received the conventional treatment protocol.
Sham Comparator: Control group
Participants in the control group underwent standard hemiarthroplasty treatment, with no administration of periarticular injections.
Procedure: Control (Standard treatment)
The control group received the conventional treatment protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative and postoperative hematocrit (HCT) and hemoglobin (Hb) levels measured over the first three days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative first three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2020

Primary Completion (Actual)

February 13, 2022

Study Completion (Actual)

February 13, 2022

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-ORT-TK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In the event that reviewers make such a request, participant data may be made available for sharing in the future.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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