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

NCT07195955 | Completed

• 1 other identifier: 2024/07.40.
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nursing care; cold application; pain; ecchymosis

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  Pain intensity at the injection site will be measured using the Visual Analog Scale (VAS). 10-cm VAS scale (0 = no pain, 10 = worst possible pain).

  Immediately after each LMWH injection.

• Ecchymosis Area

  The size of ecchymosis at the injection site will be measured using the Opsite-Flexigrid transparent film. Area calculated in cm² by tracing the ecchymosis on the grid.

  48 and 72 hours after injection.

Study Arms (2)

Cold Spray Application

EXPERIMENTAL

In patients who receive standard and routine subcutaneous low molecular weight heparin (LMWH) prophylaxis after orthopedic surgery, cold spray is applied to the injection site before this injection.

Other: Cold Spray Application

Standart (Routine) Care

NO INTERVENTION

This injection is administered without cold application to patients receiving standard and routine subcutaneous low molecular weight heparin (LMWH) prophylaxis after orthopedic surgery.

Interventions

Cold Spray Application OTHER

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

Cold Spray Application

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are:
• years of age or older
• Receiving 1 x 0.4 ml anticoagulant therapy
• Are on the first day of LMWH therapy
• Have no infection, scar tissue, lipodystrophy, or incision at the injection site
• Have not received any other parenteral therapy at the injection site
• Are not allergic to cold or heparin
• Volunteer to participate in the study

You may not qualify if:

• Patients were excluded from the study if they were: • Pregnant, • Had any acute or chronic coagulation disorder or hematological disease,
• Had a subcutaneous injection into the same area 24 hours prior,
• Wanted to withdraw from the study.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Köseköy, Kocaeli, 41100, Turkey (Türkiye)

Location

Related Publications (16)

• Ekanayake C, Gamage JCPH, Mendis P, Weerasinghe P. Revolution in orthopedic immobilization materials: A comprehensive review. Heliyon. 2023 Feb 16;9(3):e13640. doi: 10.1016/j.heliyon.2023.e13640. eCollection 2023 Mar.

  PMID: 36915506 RESULT

• Sendir M, Buyukyilmaz F, Celik Z, Taskopru I. Comparison of 3 methods to prevent pain and bruising after subcutaneous heparin administration. Clin Nurse Spec. 2015 May-Jun;29(3):174-80. doi: 10.1097/NUR.0000000000000129.

  PMID: 25856035 RESULT

• Erek Kazan, E. (2021). Hot and cold applications. In M. Kara Kaşıkçı & E. Akın (Eds.), Fundamentals of nursing: Concepts, principles, practices (1st ed., pp. 492-515). Istanbul Medical Bookstores.

  RESULT

• Lafcı, D. (2021). Hot and cold applications. In N. Sabuncu, S. Erkal İlhan, & Z. Koç (Eds.), Fundamentals of nursing care: Concepts, principles, practices (pp. 801-823). Alter Publishing.

  RESULT

• Çalışkan, N. (2021). Hot and cold applications. In T. Atabek Aşti & A. Karadağ (Eds.), Fundamentals of nursing: From knowledge to practice - Concepts, principles, skills (2nd ed., pp. 567-586). Akademi Publishing.

  RESULT

• Altaie, A. H., AbdulRazzaq, H. A., & Abd Al-hadi, A. (2013). Dose effect and risk factors on the severity of enoxaparin bruising side effect. International Journal of Clinical Pharmacy, 35(5), 950.

  RESULT

• Palese A, Aidone E, Dante A, Pea F. Occurrence and extent of bruising according to duration of administration of subcutaneous low-molecular-weight heparin: a quasi-experimental case-crossover study. J Cardiovasc Nurs. 2013 Sep-Oct;28(5):473-82. doi: 10.1097/JCN.0b013e3182578b87.

  PMID: 22760174 RESULT

• Bayram SB, Gulnar E, Caliskan N, Kosucu P, Bektas O, Bayram A, Aksoy F. The Effect of Two Types of Subcutaneous Heparin Injections on Pain, Ecchymosis, Hematoma and Drug Absorption: A Quasi-Experimental Study. J Eval Clin Pract. 2025 Feb;31(1):e14266. doi: 10.1111/jep.14266.

  PMID: 39660578 RESULT

• Amaniyan S, Varaei S, Vaismoradi M, Haghani H, Sieloff C. Effect of local cold and hot pack on the bruising of enoxaparin sodium injection site: a randomized controlled trial. Contemp Nurse. 2016 Feb;52(1):30-41. doi: 10.1080/10376178.2016.1190289. Epub 2016 Jun 5.

  PMID: 27207493 RESULT

• Karadag S, Aydinli A, Yilmaz C, Tutar N. Effect of cold application and compression on pain and bruising in subcutaneous heparin injection. J Vasc Nurs. 2023 Mar;41(1):22-26. doi: 10.1016/j.jvn.2023.01.002. Epub 2023 Jan 17.

  PMID: 36898801 RESULT

• Tosun, H. (2019). Medication management: Oral and local drug administration. In T. Atabek Aşti & A. Karadağ (Eds.), Fundamentals of nursing: From knowledge to practice - Concepts, principles, skills. Akademi Publishing.

  RESULT

• Taylor, C., Lynn, P., & Bartlett, J. (2018). Fundamentals of nursing: The art and science of person-centered care (pp. 59-380). Wolters Kluwer.

  RESULT

• Duruk, N. (2023). Nursing functions and roles. In M. Kara Kaşıkçı & E. Akın (Eds.), Fundamentals of nursing: Concepts, principles, practices (pp. 11-17). Istanbul Medical Bookstores.

  RESULT

• Flevas DA, Megaloikonomos PD, Dimopoulos L, Mitsiokapa E, Koulouvaris P, Mavrogenis AF. Thromboembolism prophylaxis in orthopaedics: an update. EFORT Open Rev. 2018 Apr 27;3(4):136-148. doi: 10.1302/2058-5241.3.170018. eCollection 2018 Apr.

  PMID: 29780621 RESULT

• Hallan SS, Kaur V, Jain V, Mishra N. Development and characterization of polymer lipid hybrid nanoparticles for oral delivery of LMWH. Artif Cells Nanomed Biotechnol. 2017 Dec;45(8):1631-1639. doi: 10.1080/21691401.2016.1276920. Epub 2017 Jan 10.

  PMID: 28071140 RESULT

• Wang H, Guan J, Zhang X, Wang X, Ji T, Hou D, Wang G, Sun J. Effect of Cold Application on Pain and Bruising in Patients With Subcutaneous Injection of Low-Molecular-Weight Heparin: A Meta-Analysis. Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620905349. doi: 10.1177/1076029620905349.

  PMID: 32372652 RESULT

MeSH Terms

Conditions

Pain; Ecchymosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations

Study Officials

• YASEMİN ÖZHANLI, Assist.Prof

  Kocaeli University

  STUDY DIRECTOR

• HATİCE MERVE ALPTEKİN, Research Assistant

  Kocaeli University

  STUDY CHAIR

• ALİ OSMAN ALTUNTAŞ, Student

  Kocaeli University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study employed a single-blind design. To prevent bias in the analysis of the research data, blinding was also applied to the outcomes assessor and statistician. The care provider and researcher in the study were composed of different individuals. When coding the research data, the study groups were coded as A and B, preventing the statistician from knowing which letter represented which group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The study was conducted experimentally with a pre-test and post-test control group.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: February 1, 2024
• Primary Completion: February 3, 2024
• Study Completion: February 1, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)