Intravenous Lidocaine in Open Lung Resection Surgery

NCT04480281 | Completed Phase 4

• 1 other identifier: CEHDF 972
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Lidocaine; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Pulmonary complications

  Measurements were recorded for 24 hours in the post operative period

Study Arms (2)

Lidocaine Group

ACTIVE COMPARATOR

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

Drug: Lidocaine Iv

Placebo Group

PLACEBO COMPARATOR

Equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively

Drug: Normal Saline

Interventions

Lidocaine Iv DRUG

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

Lidocaine Group

Normal Saline DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Hotel Dieu de France

Beirut, 1104 2020, Lebanon

Location

Related Publications (2)

• 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.

  PMID: 20588151 BACKGROUND

• 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.

  PMID: 19478674 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist specialized in cardiovascular and thoracic surgery

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: January 10, 2020
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)