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Cold Spray for Pain and Ecchymosis After Anticoagulant Prophylaxis in Orthopedic Surgery

NCT07195955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-10-07

No results posted yet for this study

Summary

Heparin is a widely used anticoagulant for thrombosis prevention, and low molecular weight heparin (LMWH) has become the preferred option due to its higher bioavailability, strong antithrombotic effect, and lower risk of complications. However, subcutaneous LMWH injections-commonly administered in the abdomen, arm, or thigh-often cause local side effects such as pain, ecchymosis, and hematoma. The incidence of ecchymosis after injection ranges between 26-89%, and various factors such as injection site, needle size, injection duration, and techniques can influence these outcomes. Cold application is frequently used to reduce injection-related pain and bruising by inducing vasoconstriction, decreasing nerve conduction, and increasing pain tolerance.

In orthopedic surgery patients, limited injection sites due to dressings, casts, or splints may increase the risk of repeated bruising and pain. Although cold compresses have been studied in reducing injection-related complications, no research has evaluated the effect of cold spray prior to LMWH administration in this patient group. Therefore, standardized studies are needed to determine whether cold spray is an effective, practical alternative for reducing pain and ecchymosis following LMWH prophylaxis after orthopedic surgery.

Conditions

  • Nursing Care
  • Cold Application
  • Pain
  • Ecchymosis

Interventions

OTHER

Cold Spray Application

A cold spray is applied to the skin at the planned injection site immediately before LMWH administration to reduce pain and ecchymosis.

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Principal Investigators

  • YASEMİN ÖZHANLI, Assist.Prof · Kocaeli University

  • HATİCE MERVE ALPTEKİN, Research Assistant · Kocaeli University

  • ALİ OSMAN ALTUNTAŞ, Student · Kocaeli University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-02-03
Completion
2025-02-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07195955 on ClinicalTrials.gov