Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

Phase 3

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: NaCl 0,9%; Drug: Lidocaine

• Registration Number: NCT03677817
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2019-04-03
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NaCl 0,9%	perioperative IV administration regimen of placebo solution (NaCl 0,9%) will be as follows: induction bolus (before intubation and at least 30 minutes before incision) followed by continuous infusion of placebo solution (NaCl 0,9%) until 2 hours after skin closure
Lidocaine	Lidocaine	perioperative IV administration regimen of lidocaine will be as follows: 1.5 mg/kg IV induction bolus dose (before intubation and at least 30 minutes before incision) followed by continuous infusion of 3.mg/kg/h, until 2 hours after skin closure

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Thoracic Surgery,University Hospital of Basel; 🇨🇭 Basel, Switzerland