- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355468
Opioid Free Anesthesia in Thoracic Surgery
Opioid-free Anaesthesia Effectiveness in Thoracic Surgery - Objective Measurement With a Skin Conductance Algesimeter: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Silesia
-
Zabrze, Silesia, Poland, 41-800
- Samodzielny Publiczny Szpital Kliniczny Nr 1
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- body mass index between 19-30 kg/m2,
- American Society of Anesthesiology (ASA) physical status between 1 and 3
Exclusion Criteria:
- lack of consent
- significant coagulopathy,
- contraindication to drugs used in protocol
- history of chronic pain,
- chest wall neoplastic invasion,
- previous thoracic spine surgery,
- mental state preventing from effective use of PCA device,
- renal failure (GFR <60 ml/min/1,73 m2)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1.
The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally.
Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane.
The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required.
After surgery, if a patient complained of pain then she/he was given i.v.
oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA).
This dose was titrated to achieve adequate analgesia.
Each patient then commenced PCA.
The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min.
Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.
|
Intraoperatively, fentanyl in fractional doses of 1-3 µg∙kg-1 were applied if the heart rate (HR; Heart Rate) or mean blood pressure (MBP; Mean Blood Pressure) increased by more than 20% above the baseline value obtained just before surgery commencement.
|
Experimental: Opioid Free Aneasthesia group
General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1.
The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally.
Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane.
The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required.
After surgery, if a patient complained of pain then she/he was given i.v.
oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA).
This dose was titrated to achieve adequate analgesia.
Each patient then commenced PCA.
The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min.
Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.
|
Before the induction of general anesthesia, a single-shot thoracic paravertebral block (ThPVB) was performed at the Th3-Th4 level. An insulated needle was used, connected to a peripheral nerve stimulator. 0.5% bupivacaine (0.3 ml∙kg-1) was then injected after a negative aspiration test. The efficacy of the blockade was checked after 20 min on both sides of the thorax with a plastic ampoule of saline. A difference in the sensation of cold between the sides of the thorax was assumed to indicate an effective block. Afterwards a continuous intravenous infusion of lidocaine and ketamine was started:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative pain related stress [oscillations per second]
Time Frame: Period before induction of anaesthesia to termination of anaesthesia
|
During general anesthesia the pain-related stress was assessed using a method of skin conductance fluctuations.
The measurement was based on changes in skin conductance that arise under the influence of a pain stimulus.
|
Period before induction of anaesthesia to termination of anaesthesia
|
Intraoperative opioid usage [mg]
Time Frame: Intraoperative period
|
Intraoperative usage of opioids was noted.
|
Intraoperative period
|
Intraoperative arterial blood pressure [mmHg]
Time Frame: Intraoperative period
|
Non-invasive arterial blood pressure was recorded every 5 minutes during operation.
|
Intraoperative period
|
Intraoperative heart rate [bpm]
Time Frame: Intraoperative period
|
Heart rate was recorded every 5 minutes during operation.
|
Intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall postoperative analgesia satisfaction
Time Frame: 48 hours
|
Overall analgesia satisfaction was recorded at 24 and 48 postoperative hours with Likert scale. The points in Likert scale were assigned as below:
|
48 hours
|
Postoperative pain intensity (VAS)
Time Frame: 48 hours
|
Pain intensity at rest was recorded with Visual Analogue Scale (VAS) at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.
Patient pointed intensity of symptoms on a 10cm ruler, where 0cm corresponded to no pain and 10cm corresponded to the strongest possible pain.
|
48 hours
|
Postoperative pain intensity (PHHPS)
Time Frame: 48 hours
|
Pain intensity at rest was recorded with Prince Henry Hospital Pain Score (PHHPS) at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. The points in PHHPS score were assigned as below: 0. No pain during coughing.
|
48 hours
|
Postoperative arterial blood pressure [mmHg]
Time Frame: 48 hours
|
Non-invasive arterial blood pressure was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.
|
48 hours
|
Postoperative heart rate [bmp]
Time Frame: 48 hours
|
Heart rate was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.
|
48 hours
|
Postoperative sedation level
Time Frame: 48 hours
|
Sedation level was was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours with Ramsay scale. The points in Ramsay scale were assigned as below:
|
48 hours
|
Postoperative analgesic requirement [mg]
Time Frame: 48 hours
|
Analgesic requirement was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.
|
48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPA-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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