Intravenous Lidocaine in Open Lung Resection Surgery

Phase 4

Completed

• Conditions: Lidocaine; Pain, Postoperative
• Interventions: Drug: Lidocaine Iv; Drug: Normal Saline

• Registration Number: NCT04480281
• Lead Sponsor: Saint-Joseph University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Status Verified: 2020-07
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-20
• Last Update Submitted: 2020-07-20
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Group	Lidocaine Iv	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
Placebo Group	Normal Saline	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 Measures

Name	Time	Method
Pain scores at rest and at cough	Measurements were made for 24 hours in the post operative period	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
Opioid consumption in the post operative period	Doses were measured for twenty four hours in the post operative period	Total dose of morphine in the post operative period is measured for patients in both arms

Secondary Outcome Measures

Name	Time	Method
Pulmonary complications	Measurements were recorded for 24 hours in the post operative period	Arterial partial carbon dioxide pressure (PCO2) measurements were recorded for patients in both arms

Trial Locations

Locations (1)

Hotel Dieu de France; 🇱🇧 Beirut, Lebanon