Clinical trial NCT05299788: Post-thoracotomy Pain Management With Active External Warming and Ice Application
Official title: The Effectiveness of Active External Warming of Patient Concurrently With Ice Application on the Incision Site on Post-thoracotomy Pain and Analgesic Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Pain, Acute
Thoracic Injury
Keywords: Postthoracotomy pain control
Active external warming
Pain management
Ice application
Nursing care
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain score
timeFrame: Pain scoring was initiated when the patient was extubated and until the postoperative 48th hour were recorded
measure: Analgesic consumption (mg)
timeFrame: 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
measure: Body temperature degree
timeFrame: The patient's body temperature was measured in the first four hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
state: Mediterrian
Study officials:
affiliation: Researher
name: Emine Kol, Dr
role: STUDY_CHAIR
References: