Comparison of the Effect of Lidocaine Infusion Applied at Different Doses During Lumbar Spinal Surgery on Hemodynamics and Postoperative Pain

NCT ID: NCT05936190

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2024-01-31

Brief Summary

The aim of this study is to investigate the effects of intravenous infusion of lidocaine at different doses (1 mg/kg/h vs. 2 mg/kg/h) in the intraoperative period in patients undergoing lumbar stabilization, whether postoperative pain, postoperative opioid use, opioid-related side effects are reduced, and its effects on intraoperative hemodynamics

Detailed Description

Lumbar stabilization surgery is among the surgical interventions with a high incidence of postoperative pain. Controlling postoperative pain and ensuring early recovery are important in terms of early neurological evaluation. It has been shown that lidocaine infusion administered during the intraoperative period causes peripheral vasodilation, synaptic transmission inhibition, and an increase in the depth of anesthesia. Because of these effects, the effects of lidocaine infusion on hemodynamic responses and recovery have been investigated. The safe dose range of lidocaine is 1-4 mg/kg, and the toxic dose is 5 mg/kg and above. Many studies have shown that lidocaine infusion suppresses the sympathetic reflex response and has a depressive effect on the cardiovascular system. In a study evaluating patients who underwent open radical prostatectomy surgery, it was found that blood pressure values were lower in patients who received intraoperative lidocaine infusion compared to the control group. In a study evaluating 60 female patients who underwent breast surgery, it was shown that the mean blood pressure value was significantly lower in patients who received lidocaine infusion. Lidocaine infusion has been applied at different doses (2-3 mg/kg/hour) and at different times in different surgical procedures, and it has been shown to be more effective in reducing postoperative pain, especially in some surgical procedures. Studies showing that lidocaine infusion provides early recovery in the perioperative period; They explain this effect of lidocaine by reducing the need for opioids and reducing the complications that affect the quality of recovery, such as opioid-related nausea and vomiting. It has been shown that 2 mg/kg/hour lidocaine infusion in patients undergoing vertebral surgery provides early and high-quality recovery by reducing the opioid requirement and reducing pain scores. In a study conducted in patients undergoing spinal fusion surgery, lidocaine was administered as a bolus of 2 mg/kg in the induction of anesthesia and infusion of 3 mg/kg/hour in the intraoperative period until the end of the surgery. Compared to the control group, the first additional analgesic need emerged later and the total amount of morphine consumption was found to be lower. Although there are studies in the literature using different doses of lidocaine in different surgeries, there are limited data on the effect of different doses of lidocaine on intraoperative postoperative pain and hemodynamics in patients who underwent vertebral surgery. In our study, we aimed to investigate the effect of different doses of lidocaine infusion (1 mg/kg/hour and 2 mg/kg/hour) on postoperative pain changes and hemodynamics. The main aim of the study is to evaluate whether 2 mg/kg/h lidocaine infusion doses reduce postoperative pain severity more than 1 mg/kg/h infusion doses in patients undergoing lumbar stabilization surgery.

Conditions

Post Operative Pain; Hemodynamic Instability; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Group L1

Group who gets 1 mg/kg/min IV lidocaine infusion during surgery

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Intravenous infusion rate of lidocaine is 1 mg/kg/min

Group L2

Group who gets 2 mg/kg/min IV lidocaine infusion during surgery

Group Type: EXPERIMENTAL

Lidocaine IV

Intervention Type: DRUG

Intravenous infusion rate of lidocaine is 2 mg/kg/min

Interventions

Lidocaine IV

Intravenous infusion rate of lidocaine is 2 mg/kg/min

Intervention Type: DRUG

Lidocaine

Intravenous infusion rate of lidocaine is 1 mg/kg/min

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ASA 1,2

Exclusion Criteria

• ASA 3,4,5
• Pediatric Patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dilek Yörükoğlu

UNKNOWN

Sponsor Role: collaborator

Ozan Uyan

UNKNOWN

Sponsor Role: collaborator

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Süheyla Karadağ Erkoç

Anesthesiology and Reanimation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Süheyla Karadağ Erkoç

Role: primary

suheylakaradag@hotmail.com

+905063994839

References

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Reference Type: RESULT

PMID: 832175 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 19919581 (View on PubMed)

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Reference Type: RESULT

PMID: 31920239 (View on PubMed)

Ibrahim A, Aly M, Farrag W. Effect of intravenous lidocaine infusion on long-term postoperative pain after spinal fusion surgery. Medicine (Baltimore). 2018 Mar;97(13):e0229. doi: 10.1097/MD.0000000000010229.

Reference Type: RESULT

PMID: 29595671 (View on PubMed)

Weinberg L, Jang J, Rachbuch C, Tan C, Hu R, McNicol L. The effects of intravenous lignocaine on depth of anaesthesia and intraoperative haemodynamics during open radical prostatectomy. BMC Res Notes. 2017 Jul 6;10(1):248. doi: 10.1186/s13104-017-2570-4.

Reference Type: RESULT

PMID: 28683817 (View on PubMed)

Choi SJ, Kim MH, Jeong HY, Lee JJ. Effect of intraoperative lidocaine on anesthetic consumption, and bowel function, pain intensity, analgesic consumption and hospital stay after breast surgery. Korean J Anesthesiol. 2012 May;62(5):429-34. doi: 10.4097/kjae.2012.62.5.429. Epub 2012 May 24.

Reference Type: RESULT

PMID: 22679539 (View on PubMed)

Other Identifiers

AnkaraULumbarSurgeryLidocaine

Identifier Type: -

Identifier Source: org_study_id