Skip to main content
OpenTrials
Completed

NCT Number: NCT05299788

Post-thoracotomy Pain Management With Active External Warming and Ice Application

The aim of study is to investigate the effects of active external warming of patient concurrently with application of ice to incision site on thoracotomy pain and analgesic consumption. The research is a quasi-experimental design with control and study groups.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University Hospital

Antalya, Mediterrian, 07058, Turkey (Türkiye)

About this study

The study was initiated after obtaining the written approval of the study centers. The center of the study and the hospital where the research was conducted. Written permission was obtained from the hospital management. Within the scope of the research, the research was explained to the participants and their consent was obtained.

The routine analgesia protocol was applied to patients in the control group. In addition to the routine analgesia protocol, the study group was administered non-pharmacological pain control interventions comprising active external warming and ice application. In the Intensive Care Unit (ICU), all patients stayed in the same area without a separator so they could easily observe each other's interventions and hear the conversations occurring during medical intervention. For this reason, the control group was evaluated first. After the last patient in the control group was transferred to the clinic, the study group was evaluated.

Active External Warming: In the literature, the use of electric blankets and warm blowing devices were recommended as the best methods for postoperative active external warming.In this study, methods used routinely in the Intensive Care Unit (ICU) such as cotton blankets and socks were used for the control group. In addition to the cotton blankets and socks, electric blankets were used for the patients in the intervention group. In accordance with the literature, the temperature of the electric blanket was set at 38 °C (Celsius) at the beginning and increased to a maximum of 40-41 °C based on the patient's body temperature.

Application of ice to the incision site: Studies have reported that the cooling effect of ice packs is higher than that of cooled gel packs. In the intervention group, an ice pack was applied to the incision site for pain control in addition to active external warming. Ice packs at 0-5 °C with external dimensions of 160 × 91 × 34 mm and a filled weight of 363 g that were kept in the fridge were used for ice application. In this study, ice packs were applied in the first 12 postoperative hours for 20 minutes every 2 hours, and a parallel pain assessment was performed.

Measurements of body temperature, analgesic consumption, and pain level were made to evaluate the effectiveness of active external warming and ice application. The measurements and follow-up of the patients in the study and control groups in the ICU were carried out by these investigators.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged between 18 and 65 years who were not underweight or obese (body mass index 19-30 kg/m2)
  • Patients woke up within the first two postoperative hours, and had been extubated were included in the study group.

Exclusion criteria

  • Patients in whom hemodynamic stabilization was not achieved 2 hours after thoracotomy,
  • patients with Raynaud's phenomenon, neuropathy, or peripheric vascular disease,
  • patients who underwent postoperative procedures that directly affect pain levels, such as decortication and thoracic wall resection,
  • patients who received preemptive analgesia for pain control,
  • patients who received analgesia through pleural, thoracal, and other catheter methods were excluded from the study.

Treatment and study plan

Active external warming

Other

In this study, methods used routinely in the Intensive Care Unit (ICU) such as cotton blankets and socks were used for the control group. In addition to the cotton blankets and socks, electric blankets were used for the patients in the intervention group. In accordance with the literature, the temperature of the electric blanket was set at 38 °C (Celsius) at the beginning and increased to a maximum of 40-41 °C based on the patient's body temperature .

ice application

Other

In the intervention group, an ice pack was applied to the incision site for pain control in addition to active external warming. Ice packs at 0-5 °C with external dimensions of 160 × 91 × 34 mm and a filled weight of 363 g that were kept in the fridge were used for ice application. To prevent direct contact of the ice pack with the patient's skin, the ice pack was wrapped in a thin cotton sheath.

Primary outcomes

  1. Pain score

    Time frame: Pain scoring was initiated when the patient was extubated and until the postoperative 48th hour were recorded

    McGill Pain Questionnaire Short-Form was used for pain assessment. The Verbal Pain Scale, contained in the McGill Pain Questionnaire Short-Form, measured pain intensity at the four-hour mark rating pain of 0 - 5 with 0 = no pain, 1 = mild pain, 2 = discomforting pain, 3 distressing pain, 4 = horrible pain and 5 = excruciating pain.

  2. Analgesic consumption (mg)

    Time frame: Analgesic consumption was started to be recorded when the patient was admitted to the intensive care unit, and until the postoperative 48th hour were recorded

    Algesic consumption: The analgesic consumption of the patient was evaluated with the analgesics used until the postoperative 48th hour. The amount of analgesic administered to the patient was recorded in milligrams.

  3. Body temperature degree

    Time frame: The patient's body temperature was measured in the first four hours postoperatively

    The patient's body temperature was recorded in degrees Celsius.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

The Effectiveness of Active External Warming of Patient Concurrently With Ice Application on the Incision Site on Post-thoracotomy Pain and Analgesic Consumption

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2022
Registry last updated
Mar 29, 2022

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.

Published trials that share one or more normalized conditions with this study.