Opioid Free Anesthesia in Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

Opioid-free Anaesthesia Effectiveness in Thoracic Surgery - Objective Measurement With a Skin Conductance Algesimeter: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355468
• Other study ID #: OPA-1
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 2018

Study information

• Verified date: October 2022
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Proper assessment of pain and adequate analgesia in thoracic surgery is a challenging issue for medical practitioners. Basic aspects of thoracic anaesthesia are general anesthesia, intubation with double lumen tube and separation of lung ventilation, however proper analgesia needs to be standardized. Role of opioids in this clinical setting is reduced due to high risk of respiratory system complications. Instead, use of opioid free anaesthesia and regional anaesthesia is proposed. The aim of this study is to compare the use of opioid anaesthesia with opioid free anaesthesia and paravertebral block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Analgesics, Opioid
• Anesthesia, Conduction
• Aneurysm, Dissecting
• Thoracic Surgery

Intervention

Drug:
• Opioid Anesthesia
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.
• Opioid Free Anaesthesia
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: immediately after anesthesia induction, lidocaine was administered as an i.v. bolus at a dose of 1.5 mg·kg-1 and ketamine in an i.v. bolus of 0.35 mg·kg-1; followed by an infusion of lidocaine 2.0 mg·kg-1·h-1 for 2 hours, continued at a dose of 1.2 mg·kg-1·h-1, and ketamine infusion 0.2 mg·kg-1·h-1 for 2 hours, continued at a dose of 0.12 mg·kg-1·h-1.

Locations

Country	Name	City	State
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1	Zabrze	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative pain related stress [oscillations per second]	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
Primary	Intraoperative opioid usage [mg]	Intraoperative usage of opioids was noted.	Intraoperative period
Primary	Intraoperative arterial blood pressure [mmHg]	Non-invasive arterial blood pressure was recorded every 5 minutes during operation.	Intraoperative period
Primary	Intraoperative heart rate [bpm]	Heart rate was recorded every 5 minutes during operation.	Intraoperative period
Secondary	Overall postoperative analgesia satisfaction	Overall analgesia satisfaction was recorded at 24 and 48 postoperative hours with Likert scale. The points in Likert scale were assigned as below: Very satisfied.; Satisfied.; Neither satisfied nor dissatisfied.; Dissatisfied.; Very dissatisfied.	48 hours
Secondary	Postoperative pain intensity (VAS)	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
Secondary	Postoperative pain intensity (PHHPS)	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.; Pain during coughing.; Pain during breathing.; Constant light pain.; Constant strong pain.	48 hours
Secondary	Postoperative arterial blood pressure [mmHg]	Non-invasive arterial blood pressure was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.	48 hours
Secondary	Postoperative heart rate [bmp]	Heart rate was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.	48 hours
Secondary	Postoperative sedation level	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: Patient is anxious and agitated or restless, or both.; Patient is co-operative, oriented, and tranquil.; Patient responds to commands only.; Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.; Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.; Patient exhibits no response.	48 hours
Secondary	Postoperative analgesic requirement [mg]	Analgesic requirement was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.	48 hours