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

NCT05299788 | Completed

• 1 other identifier: 70904504/07
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Pain, Acute; Thoracic Injury

Keywords

Postthoracotomy pain control; Active external warming; Pain management; Ice application; Nursing care

Outcome Measures

Primary Outcomes (3)

• Pain score

  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.

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

• Analgesic consumption (mg)

  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.

  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

• Body temperature degree

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

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

Study Arms (2)

The routine analgesia group

NO INTERVENTION

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.

The routine analgesia+active external warming+ice application group

EXPERIMENTAL

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

Other: Active external warming; Other: Ice application

Interventions

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 .

The routine analgesia+active external warming+ice application group

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.

The routine analgesia+active external warming+ice application group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, Mediterrian, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Thoracic Injuries; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Emine Kol, Dr

  Researher

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 29, 2022
• Study Start: January 15, 2018
• Primary Completion: January 10, 2019
• Study Completion: August 15, 2019
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After complated to study
• Access Criteria: Information will be shared by Akdeniz University Scientific Research Unit

Locations

TU (1)