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NCT Number: NCT01319682

The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion

This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion.

A total of 54 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.

Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ChungAng University

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1-level posterior lumbar fusion

Exclusion criteria

  • mental change
  • allergy to local anesthetics
  • chronic analgesics user

Treatment and study plan

Intravenous lidocaine injection

Drug

Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Other names: IV lidocaine

Intravenous normal saline injection

Drug

The patients in Group C (placebo control group) received normal saline intravenous injection

Other names: IV saline

Primary outcomes

  1. Postopeartive pain measured using Visual analogue scale at postoperative 4hour

    Time frame: post op 4hour

    Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    To check the severity of pain VAS will be measured at post op 4hour.

Secondary outcomes

  1. visual analogue scale 12 hour

    Time frame: Post op 12 hour

    Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    To check the severity of pain VAS will be measured at post op 12 hour.

  2. visual analogue scale 24hour

    Time frame: Post op 24 hour

    Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    To check the severity of pain VAS will be measured at post op 24 hour.

  3. Visual analogue scale 48hour

    Time frame: Post Op 48hour

    Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    To check the severity of pain VAS will be measured at post op 48 hour.

  4. Opioid consumption 4hour

    Time frame: Post Op 4hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.

  5. Opioid consumption 24hour

    Time frame: Post op 24 hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from 12 hour to post op 24 hour will be measured.

  6. Opioid consumption 12 hour

    Time frame: Post Op 12 hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 4hour to post op 12 hour will be measured.

  7. Opioid consumption 48hour

    Time frame: Post Op 48 hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 24 hour to post op 48 hour will be measured

  8. FPB 4 hour

    Time frame: Post Op 4 hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.

  9. FPB 12 hour

    Time frame: post op 12 hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) from post op 4 hour to post op 12 hour will be measured.

  10. FPB 24 hour

    Time frame: Post Op 24 hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 12 hour to post op 24 hour will be measured.

  11. FPB 48 hour

    Time frame: Post Op 48 hour

    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 24 hour to post op 48 hour will be measured.

Sponsors and collaborators

Lead sponsor

Chung-Ang University Hospital

Other

Registry information

Official study title

Intravenous Lidocaine for Effective Pain Relief After Posterior Lumbar Spinal Fusion: a Prospective, Randomized, Double-blind, Placebo-controlled Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2011
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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