Intravenous Lidocaine in Open Lung Resection Surgery
Primary Purpose
Lidocaine, Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Lidocaine Iv
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Lidocaine
Eligibility Criteria
Inclusion Criteria:
- American society of anesthesiologists (ASA) scores of I, II or III.
- Left or right posterolateral thoracotomy with postoperative monitoring in the intensive care unit (ICU) for at least 24 hours (h).
Exclusion Criteria:
- patient's refusal to participate
- ASA score of IV or higher
- severe hepatic or renal insufficiency
- allergy to lidocaine, morphine or NSAIDs
- cardiac arrhythmias or
- epilepsy,
- delayed extubation for more than 2 h postoperatively
- urgent surgery
Sites / Locations
- Hotel Dieu de France
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lidocaine Group
Placebo Group
Arm Description
Bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery
Equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively
Outcomes
Primary Outcome Measures
Opioid consumption in the post operative period
Total dose of morphine in the post operative period is measured for patients in both arms
Pain scores at rest and at cough
Analogue visual scale ( a 10cm scale , zero representing no pain and 10 representing the worst imaginable pain)) was used to measure pain scores for each patient at rest and at cough
Secondary Outcome Measures
Pulmonary complications
Arterial partial carbon dioxide pressure (PCO2) measurements were recorded for patients in both arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04480281
Brief Title
Intravenous Lidocaine in Open Lung Resection Surgery
Official Title
Intravenous Lidocaine Reduces Pain Scores and Opioid Consumption in Open Lung Resection Surgery: A Prospective Randomized Double-Blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint-Joseph University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in colorectal surgery.
However, no study has evaluated the effect of a continuous lidocaine infusion for open lung resection in the post-operative period. The present study aims to evaluate the influence of IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lidocaine, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine Group
Arm Type
Active Comparator
Arm Description
Bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively
Intervention Type
Drug
Intervention Name(s)
Lidocaine Iv
Intervention Description
Patients in the Lidocaine group received a bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Patients in Group Placebo received an equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively
Primary Outcome Measure Information:
Title
Opioid consumption in the post operative period
Description
Total dose of morphine in the post operative period is measured for patients in both arms
Time Frame
Doses were measured for twenty four hours in the post operative period
Title
Pain scores at rest and at cough
Description
Analogue visual scale ( a 10cm scale , zero representing no pain and 10 representing the worst imaginable pain)) was used to measure pain scores for each patient at rest and at cough
Time Frame
Measurements were made for 24 hours in the post operative period
Secondary Outcome Measure Information:
Title
Pulmonary complications
Description
Arterial partial carbon dioxide pressure (PCO2) measurements were recorded for patients in both arms
Time Frame
Measurements were recorded for 24 hours in the post operative period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American society of anesthesiologists (ASA) scores of I, II or III.
Left or right posterolateral thoracotomy with postoperative monitoring in the intensive care unit (ICU) for at least 24 hours (h).
Exclusion Criteria:
patient's refusal to participate
ASA score of IV or higher
severe hepatic or renal insufficiency
allergy to lidocaine, morphine or NSAIDs
cardiac arrhythmias or
epilepsy,
delayed extubation for more than 2 h postoperatively
urgent surgery
Facility Information:
Facility Name
Hotel Dieu de France
City
Beirut
ZIP/Postal Code
1104 2020
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20588151
Citation
Swenson BR, Gottschalk A, Wells LT, Rowlingson JC, Thompson PW, Barclay M, Sawyer RG, Friel CM, Foley E, Durieux ME. Intravenous lidocaine is as effective as epidural bupivacaine in reducing ileus duration, hospital stay, and pain after open colon resection: a randomized clinical trial. Reg Anesth Pain Med. 2010 Jul-Aug;35(4):370-6. doi: 10.1097/AAP.0b013e3181e8d5da.
Results Reference
background
PubMed Identifier
19478674
Citation
Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.
Results Reference
result
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Intravenous Lidocaine in Open Lung Resection Surgery
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