Back to results

Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Lidocaine

NaCl 0,9%

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring thoracoscopic surgery, Perioperative intravenous lidocaine administration, Lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Thoracic Surgery,University Hospital of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in total morphine consumption (TMC)

change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA)

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])

Secondary Outcome Measures

Duration of hospital stay

length of hospital stay (in days)

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)

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])

occurrence of nausea and/or vomiting

Full Information

NCT ID

NCT03677817

First Posted

September 11, 2018

Last Updated

September 5, 2022

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT03677817

Brief Title

Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

April 3, 2019 (Actual)

Primary Completion Date

August 28, 2022 (Actual)

Study Completion Date

August 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

thoracoscopic surgery, Perioperative intravenous lidocaine administration, Lidocaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NaCl 0,9%

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in total morphine consumption (TMC)

Description

change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA)

Time Frame

within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure

Title

change in pain intensity

Description

Time Frame

within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure

Secondary Outcome Measure Information:

Title

Duration of hospital stay

Description

length of hospital stay (in days)

Time Frame

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

Title

time to first defecation - Defined as the time from skin closure to the time of first defecation

Description

time to first defecation - Defined as the time from skin closure to the time of time to first defecation (measured in hours)

Time Frame

From timepoint of surgical skin closure (end of surgery) to the timepoint of first defecation after surgical skin closure (an average of 2 days)

Title

Change in chronic pain

Description

Time Frame

2 weeks, 3 months and 6 months after surgery

Title

occurrence of nausea and/or vomiting

Description

occurrence of nausea and/or vomiting

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier Lardinois, Prof. Dr. MD

Organizational Affiliation

University Hospital, Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Thoracic Surgery,University Hospital of Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

We'll reach out to this number within 24 hrs