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

Primary Purpose

Post Operative Pain, Pain, Acute, Thoracic Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Active external warming
Ice application
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain focused on measuring Postthoracotomy pain control, Active external warming, Pain management, Ice application, Nursing care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Akdeniz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

The routine analgesia group

The routine analgesia+active external warming+ice application group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2022
Last Updated
March 18, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05299788
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Pain, Acute, Thoracic Injury
Keywords
Postthoracotomy pain control, Active external warming, Pain management, Ice application, Nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The routine analgesia group
Arm Type
No Intervention
Arm Description
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.
Arm Title
The routine analgesia+active external warming+ice application group
Arm Type
Experimental
Arm Description
In addition to the routine analgesia protocol, the study group was administered non-pharmacological pain control interventions.
Intervention Type
Other
Intervention Name(s)
Active external warming
Intervention Description
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
Intervention Name(s)
Ice application
Intervention Description
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 Outcome Measure Information:
Title
Pain score
Description
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.
Time Frame
Pain scoring was initiated when the patient was extubated and until the postoperative 48th hour were recorded
Title
Analgesic consumption (mg)
Description
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.
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
Title
Body temperature degree
Description
The patient's body temperature was recorded in degrees Celsius.
Time Frame
The patient's body temperature was measured in the first four hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine Kol, Dr
Organizational Affiliation
Researher
Official's Role
Study Chair
Facility Information:
Facility Name
Akdeniz University Hospital
City
Antalya
State/Province
Mediterrian
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information will be shared by Akdeniz University Scientific Research Unit
IPD Sharing Time Frame
After complated to study
IPD Sharing Access Criteria
Information will be shared by Akdeniz University Scientific Research Unit
IPD Sharing URL
http://www.akdeniz.edu.tr/

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

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