Efficacy of Intraoperative Periarticular Injections in Hip Fracture Hemiarthroplasty

NCT06701695 | Completed

• 1 other identifier: AnkaraCHBilkent-ORT-TK-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures; Hemiarthroplasty; Blood Loss Requiring Transfusion

Keywords

Hip Fracture; Hemiarthroplasty; Periarticular injection; Blood loss; Blood transfusion requirement

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss

  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 Outcomes (1)

• Hidden Blood Loss

  Postoperative first three days

Study Arms (2)

Periarticular injection group

ACTIVE COMPARATOR

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); Procedure: Control (Standard treatment)

Control group

SHAM COMPARATOR

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

Procedure: Control (Standard treatment)

Interventions

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.

Periarticular injection group

Control (Standard treatment) PROCEDURE

The control group received the conventional treatment protocol.

Control group; Periarticular injection group

Eligibility Criteria

• Age: 58 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of femoral neck fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (19)

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  PMID: 34709457 RESULT

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MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures; Hemorrhage

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: During the trial, patients were kept unaware of their group assignments, ensuring they remained blinded to the study parameters. While the surgeon possessed knowledge of the group allocations, he was not directly involved in patient data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Two groups were established, one serving as the control group receiving standard hemiarthroplasty treatment.

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: May 11, 2020
• Primary Completion: February 13, 2022
• Study Completion: February 13, 2022
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)