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

Primary Purpose

Post Operative Pain, Hemodynamic Instability, Opioid Use

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lidocaine IV
Lidocaine
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Post Operative Pain focused on measuring lidocaine, infusion, postoperative pain, lumbar surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA 1,2 Exclusion Criteria: ASA 3,4,5 Pediatric Patients

Sites / Locations

  • Ankara UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group L1

Group L2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assessing Postoperative pain with the pain scoring system (Visual Pain Scale).
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

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

Full Information

First Posted
March 23, 2023
Last Updated
June 28, 2023
Sponsor
Ankara University
Collaborators
Dilek Yörükoğlu, Ozan Uyan
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1. Study Identification

Unique Protocol Identification Number
NCT05936190
Brief Title
Comparison of the Effect of Lidocaine Infusion Applied at Different Doses During Lumbar Spinal Surgery on Hemodynamics and Postoperative Pain
Official Title
Comparison of the Effect of Lidocaine Infusion Applied at Different Doses During Lumbar Spinal Surgery on Hemodynamics and Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
Collaborators
Dilek Yörükoğlu, Ozan Uyan

4. Oversight

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

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Hemodynamic Instability, Opioid Use
Keywords
lidocaine, infusion, postoperative pain, lumbar surgery

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group L1
Arm Type
Active Comparator
Arm Description
Group who gets 1 mg/kg/min IV lidocaine infusion during surgery
Arm Title
Group L2
Arm Type
Experimental
Arm Description
Group who gets 2 mg/kg/min IV lidocaine infusion during surgery
Intervention Type
Drug
Intervention Name(s)
Lidocaine IV
Intervention Description
Intravenous infusion rate of lidocaine is 2 mg/kg/min
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Intravenous infusion rate of lidocaine is 1 mg/kg/min
Primary Outcome Measure Information:
Title
Assessing Postoperative pain with the pain scoring system (Visual Pain Scale).
Description
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).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Monitoring Intraoperative blood pressure
Description
The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative blood pressure
Time Frame
2 hours
Title
Monitoring intraoperative heart rate
Description
The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative heart rate
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1,2 Exclusion Criteria: ASA 3,4,5 Pediatric Patients
Facility Information:
Facility Name
Ankara University
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Süheyla Karadağ Erkoç
Phone
+905063994839
Email
suheylakaradag@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
832175
Citation
Abou-Madi MN, Keszler H, Yacoub JM. Cardiovascular reactions to laryngoscopy and tracheal intubation following small and large intravenous doses of lidocaine. Can Anaesth Soc J. 1977 Jan;24(1):12-9. doi: 10.1007/BF03006808.
Results Reference
result
PubMed Identifier
29864216
Citation
Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.
Results Reference
result
PubMed Identifier
19919581
Citation
Saadawy IM, Kaki AM, Abd El Latif AA, Abd-Elmaksoud AM, Tolba OM. Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2010 May;54(5):549-56. doi: 10.1111/j.1399-6576.2009.02165.x. Epub 2009 Nov 16.
Results Reference
result
PubMed Identifier
31920239
Citation
Koshyari HS, Asthana V, Agrawal S. Evaluation of lignocaine infusion on recovery profile, quality of recovery, and postoperative analgesia in patients undergoing total abdominal hysterectomy. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):528-532. doi: 10.4103/joacp.JOACP_209_18.
Results Reference
result
PubMed Identifier
29595671
Citation
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.
Results Reference
result
PubMed Identifier
28683817
Citation
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.
Results Reference
result
PubMed Identifier
22679539
Citation
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.
Results Reference
result

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

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