NCT05936190

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 23, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

March 23, 2023

Last Update Submit

January 29, 2024

Conditions

Post Operative PainHemodynamic InstabilityOpioid Use

Keywords

lidocaineinfusionpostoperative painlumbar surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Monitoring Intraoperative blood pressure

    2 hours

  • Monitoring intraoperative heart rate

    2 hours

Study Arms (2)

Group L1

ACTIVE COMPARATOR

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

Drug: Lidocaine

Group L2

EXPERIMENTAL

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

Drug: Lidocaine IV

Interventions

Lidocaine IVDRUG

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

Group L2
LidocaineDRUG

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

Group L1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1,2

You may not qualify if:

  • ASA 3,4,5
  • Pediatric Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Related 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.

    PMID: 832175RESULT

  • 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.

    PMID: 29864216RESULT

  • 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.

    PMID: 19919581RESULT

  • 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.

    PMID: 31920239RESULT

  • 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.

    PMID: 29595671RESULT

  • 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.

    PMID: 28683817RESULT

  • 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.

    PMID: 22679539RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation

Study Record Dates

First Submitted

March 23, 2023

First Posted

July 7, 2023

Study Start

February 10, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

TU(1)