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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936190
• Other study ID #: AnkaraULumbarSurgeryLidocaine
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA 1,2

Exclusion Criteria:

• ASA 3,4,5

• Pediatric Patients

Related Conditions & MeSH terms

• Hemodynamic Instability
• Opioid Use
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Lidocaine IV
Intravenous infusion rate of lidocaine is 2 mg/kg/min
• Lidocaine
Intravenous infusion rate of lidocaine is 1 mg/kg/min

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara

Sponsors (3)

Lead Sponsor	Collaborator
Ankara University	Dilek Yörükoglu, Ozan Uyan

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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/kj — View 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. — View 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: — View 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. — View 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; — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 hours
Secondary	Monitoring Intraoperative blood pressure	The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative blood pressure	2 hours
Secondary	Monitoring intraoperative heart rate	The secondary endpoint was to determine and compare the effect of two different infusion doses on intraoperative heart rate	2 hours