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

Sponsor
Ankara University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05936190
Collaborator
Dilek Yörükoğlu (Other), Ozan Uyan (Other)
80
1
2
10.6
7.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Comparison of the Effect of Lidocaine Infusion Applied at Different Doses During Lumbar Spinal Surgery on Hemodynamics and Postoperative Pain
Actual Study Start Date :
Feb 10, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group L1

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

Drug: Lidocaine
Intravenous infusion rate of lidocaine is 1 mg/kg/min

Experimental: Group L2

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

Drug: Lidocaine IV
Intravenous infusion rate of lidocaine is 2 mg/kg/min

Outcome Measures

Primary Outcome Measures

  1. Assessing Postoperative pain with the pain scoring system (Visual Pain Scale). [24 hours]

    The primary endpoint was the evaluation and comparison of two different infusion doses (2 mg/kg/hr and 1 mg/kg/hr) of postoperative pain with the pain scoring system (Visual Pain Scale).

Secondary Outcome Measures

  1. Monitoring Intraoperative blood pressure [2 hours]

    The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative blood pressure

  2. Monitoring intraoperative heart rate [2 hours]

    The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA 1,2
Exclusion Criteria:
  • ASA 3,4,5

  • Pediatric Patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara University Ankara Turkey 06230

Sponsors and Collaborators

  • Ankara University
  • Dilek Yörükoğlu
  • Ozan Uyan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Süheyla Karadağ Erkoç, Anesthesiology and Reanimation, Ankara University
ClinicalTrials.gov Identifier:
NCT05936190
Other Study ID Numbers:
  • AnkaraULumbarSurgeryLidocaine
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Süheyla Karadağ Erkoç, Anesthesiology and Reanimation, Ankara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023