Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

Postoperative Pain Clinical Trial

Official title:

Prospective, Randomized, Double Blind, Superiority Trial, Evaluating the Effect of Perioperative Lidocaine on Postoperative Opioid Consumption, Pain Ratings, Duration of Hospital Stay, Time to First Defecation, 30-day Mortality and Development of Chronic Pain in Patients Undergoing Video-assisted Thoracoscopic Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677817
• Other study ID #: 2016-00259; ch15Toffel
• Status: Completed
• Phase: Phase 3
• Start date: April 3, 2019
• Est. completion date: August 28, 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 28, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine
regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h
• NaCl 0,9%
IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%

Locations

Country	Name	City	State
Switzerland	Division of Thoracic Surgery,University Hospital of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total morphine consumption (TMC)	change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA)	within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure
Primary	change in pain intensity	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])	within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure
Secondary	Duration of hospital stay	length of hospital stay (in days)	from day of surgery until day of discharge from hospital (an average of 2 days)
Secondary	time to first defecation - Defined as the time from skin closure to the time of first defecation	time to first defecation - Defined as the time from skin closure to the time of time to first defecation (measured in hours)	From timepoint of surgical skin closure (end of surgery) to the timepoint of first defecation after surgical skin closure (an average of 2 days)
Secondary	Change in chronic pain	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])	2 weeks, 3 months and 6 months after surgery
Secondary	occurrence of nausea and/or vomiting	occurrence of nausea and/or vomiting	from the date of surgery until the date of discharge from hospital (an average of 2 days)