Clinical trial NCT06310850: The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety
Official title: The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epidural Catheterization
Thoracic
Procedural Pain
Keywords: ketamine
pain
anxiety
subanesthetic
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized, prospective study
Primary purpose: PREVENTION

Brief summary: The thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure.

Detailed description: The study aimed to assess the impact of subanesthetic intravenous ketamine administration on pain and anxiety during Thoracic Epidural Catheterisation (TEC) procedure, which can be uncomfortable and frightening for patients when performed awake due to the possibility of pain.

After receiving approval from the clinical research ethics committee of Keçiören Education and Research Hospital (KEAH; ID:238), this prospective and randomized study will include 60 adult patients with ASA physical status I-III who are scheduled for elective thoracic surgery via thoracotomy. The study will randomly assign patients into two groups: Group P (n=30) receiving an intravenous placebo and Group K (n=30) receiving intravenous (IV) 0.15 mg kg-1 ketamine. Randomisation will be performed using a computerised table of random numbers.

Patients with chronic pain, bleeding disorders, drug use, liver disease, severe metabolic and endocrine problems, a history of ketamine or local anaesthetic allergy, infection at the site of intervention, or refusal of TEC will be excluded. Patients who report acute pain during preoperative evaluation, have a TEC time of more than five minutes (from needle insertion to catheter insertion), and require more than two Tuohy needle attempts will be excluded. Vital parameters and anxiety levels of each patient will be recorded before premedication. Anxiety (VAS-A) and pain (VAS-P) scores will be measured using the visual analogue scale. Patients will be transported to the operating theatre 20 minutes after premedication. Intravenous administration of 0.15 mg/kg IV ketamine or placebo will take place 3 minutes before TEC placement.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent elective thoracic surgery via thoracotomy
* Patients with ASA physical status I-III

Exclusion Criteria:

* Describing chronic pain,
* Have a bleeding disorder,
* Having a history of analgesia drug use,
* Have a history of liver disease,
* Have serious metabolic and endocrine problems,
* Have a history of allergy to ketamine and local anesthetics,
* Have an infection in the intervention area,
* Rejecting thoracic epidural catheter,
* Describing acute pain in any part of the body during the preoperative evaluation,
* Thoracic epidural catheter duration greater than five minutes (time from needle entry to catheter placement)
* Patients requiring more than two Tuohy injection attempts

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 1 day (5 times)
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Atatürk Sanatorium Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Ankara Ataturk Sanatorium Training and Research Hospital
name: Onur KÜÇÜK, specialist
role: PRINCIPAL_INVESTIGATOR
References: