Epidural CatheterizationPhase 3NCT06310850
The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety
A Phase 3 study testing Ketamine in people with Epidural Catheterization and Thoracic, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidural Catheterization, Thoracic, Procedural Pain
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2013to 1 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent elective thoracic surgery via thoracotomy
- Patients with ASA physical status I-III
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Keçiören, 06290
About this study
Official title: The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial
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.
Read the 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.
- Conditions
- Epidural Catheterization, Thoracic, Procedural Pain
- Being tested
- Ketamine, Placebo
- Keywords
- ketamine, pain, anxiety, subanesthetic
- Medical subject headings
- Pain, Procedural, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Patients will be administered 0.15 mg kg-1 intravenous ketamine (The sample provided contains equal proportions of two enantiomers, S and R ketamine hydrochloride.) 3 minutes before thoracic epidural catheter placement.
PlaceboOther
Intravenous saline will be administered to patients 3 minutes before the thoracic epidural catheter is placed.
| Study group | Role | What they receive |
|---|---|---|
| Group Placebo | Placebo comparator | intravenous placebo Receives: Other: Placebo |
| Group Ketamine | Active comparator | intravenous ketamine 0.15 mg kg-1 Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
For anxiety, on a 100 mm scale, 0 mm was defined as no anxiety, whereas 100 mm was as unbearable anxiety (VAS-A). A similar scoring method was used to assess pain intensity. 0 mm was defined as no pain and 100 mm as unbearable pain (VAS-P).
Measured: 1 day (5 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jun 2013
- Primary completion1 Jan 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a randomized, prospective study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Onur Kucuk, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Onur KÜÇÜK, specialist, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310850
- Sponsor's protocol ID
- KEAH-238
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06310850
- Acronym / sponsor ID
- KEAH-238
- Conditions
- Epidural Catheterization, Thoracic, Procedural Pain
- Keywords
- ketamine, pain, anxiety, subanesthetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was designed as a randomized, prospective study
| Arm | Type | Receives |
|---|---|---|
| Group Placebo | Placebo comparator | Other: Placebointravenous placebo |
| Group Ketamine | Active comparator | Drug: Ketamineintravenous ketamine 0.15 mg kg-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent elective thoracic surgery via thoracotomy
- Patients with ASA physical status I-III
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetaminePatients will be administered 0.15 mg kg-1 intravenous ketamine (The sample provided contains equal proportions of two enantiomers, S and R ketamine hydrochloride.) 3 minutes before thoracic epidural catheter placement. | Drug | Group Ketamine |
| PlaceboIntravenous saline will be administered to patients 3 minutes before the thoracic epidural catheter is placed. | Other | Group Placebo |
Primary outcome
Visual analog scale (VAS)
Time frame: 1 day (5 times)
For anxiety, on a 100 mm scale, 0 mm was defined as no anxiety, whereas 100 mm was as unbearable anxiety (VAS-A). A similar scoring method was used to assess pain intensity. 0 mm was defined as no pain and 100 mm as unbearable pain (VAS-P).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onur KÜÇÜK, specialist principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine in people with Epidural Catheterization and Thoracic, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: 1 day (5 times)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.