Postoperative Pain
Conditions
Keywords
thoracoscopic surgery, Perioperative intravenous lidocaine administration, Lidocaine
Brief summary
Placebo-controlled study to analyze the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .
Detailed description
Thoracoscopy (thoracic surgery) is a video-assisted minimally invasive operation in thoracic surgery, which is associated with pain after surgery. Trial drug Lidocaine is approved as pain medication. This placebo-controlled study analyzes the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery . Half of the patients will receive NaCl 0.9% (a saline solution without active ingredient) instead of Lidocaine.
Interventions
DRUGLidocaine
regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h
DRUGNaCl 0,9%
IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing video-assisted thoracoscopic procedures under general anaesthesia. * American Society of Anesthesiologists (ASA) physical Status classes I to III * age ≥ 18 years * Patient informed consent
Exclusion criteria
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product * Contraindications to self-administration of opioids * Women who are pregnant or breast feeding * Steroid therapy * Chronic pain therapy * Atrioventricular block grade II to III * Congestive heart failure * Liver insufficiency * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Enrolment of the investigator, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total morphine consumption (TMC) | within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure | change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA) |
| change in pain intensity | within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure | change in pain intensity of at least 1.5 units on the Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity; the scale is anchored by no pain (score of 0) and worst imaginable pain (score of 100 \[100-mm scale\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | from day of surgery until day of discharge from hospital (an average of 2 days) | length of hospital stay (in days) |
| time to first defecation - Defined as the time from skin closure to the time of first defecation | From timepoint of surgical skin closure (end of surgery) to the timepoint of first defecation after surgical skin closure (an average of 2 days) | time to first defecation - Defined as the time from skin closure to the time of time to first defecation (measured in hours) |
| Change in chronic pain | 2 weeks, 3 months and 6 months after surgery | Change in pain intensity (with and without coughing) on the Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity; the scale is anchored by no pain (score of 0) and worst imaginable pain (score of 100 \[100-mm scale\]) |
| occurrence of nausea and/or vomiting | from the date of surgery until the date of discharge from hospital (an average of 2 days) | occurrence of nausea and/or vomiting |
Countries
Switzerland
Outcome results
None listed