Clinical trial NCT06974071: Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery
Official title: Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery, Study Protocol
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain Management
Keywords: cardiac surgery
pain management
chest drain
non-pharmacological therapy
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Specific treatment protocol for each group. The procedures will be performed by two nurses who are part of the research, as co-investigators and project assistants, being clinical nurses of the Unit, the procedures to be performed will be assisted by Senior Nursing Technicians (TENS) on duty. This will be performed between 11:00 - 13:00, at a time to be agreed upon by the nurses, this time is preferred because of the time difference with the administration of usual analgesic treatment. The nurses do not need separate training in drain removal due to experience in the area, and the recent refresher course in the management of chest drains, and the drain removal protocol in which they participated as authors.
* Usual treatment: Patients with indication for drainage removal after cardiac surgery, with analgesia according to the protocol indicated by the resident physician, the routine technique will be performed.
* Experimental treatment with
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

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Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of patient-reported pain using the visual numerical pain scale.
timeFrame: Pain measurement at 5, 10 and 20 minutes after drain removal.
Secondary outcomes:
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Claro Solar 115, Temuco
state: Araucanía (IX)
Study officials:
References: