Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

NCT03677817 | Completed Phase 3

• 1 other identifier: 2016-00259; ch15Toffel
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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 .

Conditions

Postoperative Pain

Keywords

thoracoscopic surgery; Perioperative intravenous lidocaine administration; Lidocaine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Duration of hospital stay

  from day of surgery until day of discharge from hospital (an average of 2 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)

• Change in chronic pain

  2 weeks, 3 months and 6 months after surgery

• occurrence of nausea and/or vomiting

  from the date of surgery until the date of discharge from hospital (an average of 2 days)

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

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

Drug: NaCl 0,9%

Interventions

Lidocaine DRUG

regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h

Lidocaine

NaCl 0,9% DRUG

IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Division of Thoracic Surgery,University Hospital of Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Hojski A, Bolliger D, Mallaev M, Dackam S, Tsvetkov N, Wiese M, Schneider T, Lampart A, Lardinois D. Perioperative intravenous lidocaine in thoracoscopic surgery for improved postoperative pain control: a randomized, placebo-controlled, double-blind, superiority trial. J Thorac Dis. 2024 Mar 29;16(3):1923-1932. doi: 10.21037/jtd-23-1438. Epub 2024 Mar 25.

  PMID: 38617784 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Didier Lardinois, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 19, 2018
• Study Start: April 3, 2019
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

CH (1)