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

NCT ID: NCT05299788

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2019-08-15

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.

Conditions

Post Operative Pain; Pain, Acute; Thoracic Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

The routine analgesia group

The routine analgesia and warming protocol was applied to patients in the control group.The routine postoperative analgesic treatment protocol at the unit comprises the administration of 75 mg IM (Intramuscular) Diclofenac Sodium before the patient wakes up, 30 mg intravenous (IV) Tramadol if the patient complains of pain when awake (maximum dose of 100 mg/day), and 10 mg/day Morphine Sulfate. In addition to, methods used routinely in the Intensive Care Unit (ICU) such as cotton blankets and socks were used for warming.

Group Type: NO_INTERVENTION

No interventions assigned to this group

The routine analgesia+active external warming+ice application group

In addition to the routine analgesia protocol, the study group was administered non-pharmacological pain control interventions.

Group Type: EXPERIMENTAL

Active external warming

Intervention Type: 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

Intervention Type: 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.

Interventions

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 .

Intervention Type: OTHER

Ice application

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Emine Kol

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine Kol, Dr

Role: STUDY_CHAIR

Researher

Locations

Akdeniz University Hospital

Antalya, Mediterrian, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

70904504/07

Identifier Type: -

Identifier Source: org_study_id