Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery (NPT)

Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery, Study Protocol

The objective of this clinical trial is to determine the effectiveness of pain reduction between an experimental treatment and the usual one when removing thoracic drains in post cardiac surgery patients, in a Cardiovascular Critical Patient Unit, in Temuco, between the years 2024- 2026. Its safety will also be analyzed. The main questions to be answered are:

- What is the effectiveness of non-pharmacological therapies in reducing pain in the removal of chest drains in post-operated patient of cardiac surgery, in Cardiovascular Critical Patient Unit, Temuco, between the years 2024- 2026?

Participants:

• Two non-pharmacological therapies will be applied, to one group aromatherapy with lavender essential oils, which were previously submitted to oil property analysis. And another group with local cold therapy, there will also be a control group with the usual pharmacological therapy.
• All the groups will receive the usual pharmacological treatment, the non pharmacological therapies will only be of support, in no case they will replace the usual medical therapy.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain Management
• Intervention / Treatment: Other: Local cold therapy.; Other: Lavender oil.

Detailed Description

Controlled clinical trial, randomized, single-blind, with a sample of 100 postoperative cardiac surgery patients who meet inclusion and exclusion criteria. The sample will be obtained by two nurses with more than 8 years of experience in cardiac intensive care and specializations, of these patients all will receive the usual pharmacological therapy, will be divided into three groups: 25 patients (local cold); 25 patients (aromatherapy); 50 patients (with usual pharmacological therapy, indicated by medical team, without adding TNF). Data will be collected through a form. The database will be exported to STATA CORP18 software, where they will be analyzed. The ethical requirements of Ezequiel Emanuel will be considered.

Translated with DeepL.com (free version)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Araucanía (IX)
    • Temuco, Araucanía (IX), Chile, 4780000
      • Claro Solar 115, Temuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Postoperative cardiac surgery patient with indication of the cardiac surgeon to remove chest drains within the first 24 hours postoperatively.
• Patient who follows orders and with vigil state of consciousness, temporally and spatially oriented.
• Usual analgesic treatment indicated by physician: paracetamol 1 g every 8 hours; or Metamizole 1 g every 8 hours; Ketoprofen every 8 hours, or pregabalin 75 mg every 24 hours, last administration at 07:00 am.
• INR < 2.5; Platelets > 50,000.

Exclusion Criteria:

• Patient with psychomotor agitation
• Dependence on psychotropic drugs, alcohol, or with abstinence syndrome.
• Patient in postoperative course with cardiogenic shock, with need for 2 or more vasoactive drugs (VAD).
• Older than 80 years old.
• Maintained with continuous infusion pump (CIB) of analgesia.
• Refractory pain, with second line management: Lidocaine patches, Buprenorphine patches, Patient controlled analgesia pump.
• Administration of anticoagulant at 07:00 am.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local cold application group; patients with indication for removal of drains after cardiac surgery, with analgesia according to the protocol indicated by the resident physician, to whom local cold will be applied . If after the removal of drains there is pain that does not subside with complementary therapy, extra analgesia may be requested.	Other: Local cold therapy.; It will be applied by means of a refrigerated unit based on gel pack, these units will be stored in the refrigerator of the Unit, which is kept between 2 - 6 degrees, the application protocol is described in Annex B, this was reviewed in conjunction with quality nurses of the Cardiovascular Unit, to avoid biases.
Experimental: Aromatherapy group; Patients with indication for removal of drains after cardiac surgery, with analgesia according to protocol indicated by resident physician, who at the time of removal of drains will be applied aromatherapy with lavender oil. If after the removal of drains has a pain that does not subside, with complementary therapy, you can request extra analgesia.	Other: Lavender oil.; Lavender essential oil will be used by applying 5 drops in a sterile dressing 15x15 which will be placed on the side of the patient's bedside at 10 cm from the patient. To maintain the safety of the patients and ensure the quality of the products, two essential oils will be chosen, certified by the Institute of Public Health (ISP), the first one "Lavender essential oil, body and aromatherapy use" of the Weleda brand, with sanitary authorization N° 154C-15 and the essential oil Doterra, sanitary authorization N° 2832C-6/21, with authorization by the Food and Drugs Administration (FDA), in charge of ensuring the quality of substances that are marketed from the United States to the rest of the world. These oils will be subjected to a characterization process, choosing the one with the highest quality and purity, through the protocol sent by the Scientific and Technological Nucleus in Bioresources (BioRen), which are specified in section 5.10.
No Intervention: Control group.; Patients with indication for removal of drains after cardiac surgery, with analgesia according to the protocol indicated by the resident physician, the routine technique will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of patient-reported pain using the visual numerical pain scale.	Pain measurement at 5, 10 and 20 minutes after drain removal. For quantification of pain using the visual numerical pain scale. it was divided into mild 1 -3 , moderate 4-6 and severe 7-10. It is necessary for the patient to understand the meaning and content of the scale, for which reason the patient must be in adequate cognitive condition to guarantee his or her ability to collaborate.	Pain measurement at 5, 10 and 20 minutes after drain removal.

Collaborators and Investigators

• Sponsor: Universidad de La Frontera

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2025
• Primary Completion (Estimated): September 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: May 7, 2025
• First Submitted That Met QC Criteria: May 14, 2025
• First Posted (Actual): May 15, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; pain management; non-pharmacological therapy; chest drain
• Other Study ID Numbers: DIM24-0009 (Other Grant/Funding Number: UNIVERSIDAD DE LA FRONTERA.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Under no circumstances will personal information of the enrolled subjects be shared, data such as:

• Ages.
• Pain assessment.
• Gender.
• Type of surgery.
• Number of drains.

• IPD Sharing Time Frame: Beginning 3 months and ending 3 years after the publication of results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No