Intravenous Lidocaine in Open Lung Resection Surgery

Pain, Postoperative Clinical Trial

Official title:

Intravenous Lidocaine Reduces Pain Scores and Opioid Consumption in Open Lung Resection Surgery: A Prospective Randomized Double-Blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480281
• Other study ID #: CEHDF 972
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2020
• Est. completion date: May 15, 2020

Study information

• Verified date: July 2020
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lidocaine
• Pain, Postoperative

Intervention

Drug:
• Lidocaine Iv
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
• Normal Saline
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

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (2)

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: — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption in the post operative period	Total dose of morphine in the post operative period is measured for patients in both arms	Doses were measured for twenty four hours in the post operative period
Primary	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	Measurements were made for 24 hours in the post operative period
Secondary	Pulmonary complications	Arterial partial carbon dioxide pressure (PCO2) measurements were recorded for patients in both arms	Measurements were recorded for 24 hours in the post operative period