Postoperative PainPhase 4NCT01319682
The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion
A Phase 4 study testing Intravenous lidocaine injection and Intravenous normal saline injection in people with Postoperative Pain, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intravenous lidocaine injection and Intravenous normal saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1-level posterior lumbar fusion
Who cannot join
- mental change
- allergy to local anesthetics
- chronic analgesics user
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Lidocaine for Effective Pain Relief After Posterior Lumbar Spinal Fusion: a Prospective, Randomized, Double-blind, Placebo-controlled Study
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.
Read more
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.
- Conditions
- Postoperative Pain
- Being tested
- Intravenous lidocaine injection, Intravenous normal saline injection
- Keywords
- Pain, Preemptive, Lidocaine, Intravenous, Lumbar fusion
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lidocaine injectionDrug
Also called IV lidocaine
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.
Intravenous normal saline injectionDrug
Also called IV saline
The patients in Group C (placebo control group) received normal saline intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine injection group | Active comparator | 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. Receives: Drug: Intravenous lidocaine injection |
| Placebo control group | Placebo comparator | Patients in Group C (placebo control group) received normal saline intravenous injection Receives: Drug: Intravenous normal saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postopeartive pain measured using Visual analogue scale at postoperative 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.
Measured: post op 4hour
Secondary outcomes (11)
visual analogue scale 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.
Measured: Post op 12 hour
visual analogue scale 24hour
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.
Measured: Post op 24 hour
Visual analogue scale 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.
Measured: Post Op 48hour
Opioid consumption 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.
Measured: Post Op 4hour
Opioid consumption 24hour
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.
Measured: Post op 24 hour
Opioid consumption 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.
Measured: Post Op 12 hour
Opioid consumption 48hour
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
Measured: Post Op 48 hour
FPB 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.
Measured: Post Op 4 hour
FPB 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.
Measured: post op 12 hour
FPB 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.
Measured: Post Op 24 hour
FPB 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.
Measured: Post Op 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Kang, Chung-Ang University Hospital
- Investigators
- Hyun Kang, Ph.D.,, Study chair, Chung-Ang University HospitalYoung-Baeg Kim, Ph.D., Study director, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319682
- Sponsor's protocol ID
- ChungAngUH2
- Status last verified
- Mar 2011
- First submitted
- 21 Mar 2011
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.
PubMed 24216403
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine for Effective Pain Relief After Posterior Lumbar Spinal Fusion: a Prospective, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01319682
- Acronym / sponsor ID
- ChungAngUH2
- Conditions
- Postoperative Pain
- Keywords
- Pain, Preemptive, Lidocaine, Intravenous, Lumbar fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine injection group | Active comparator | Drug: Intravenous lidocaine injectionPatients 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. |
| Placebo control group | Placebo comparator | Drug: Intravenous normal saline injectionPatients in Group C (placebo control group) received normal saline intravenous injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1-level posterior lumbar fusion
Key exclusion criteria (3 listed)
- mental change
- allergy to local anesthetics
- chronic analgesics user
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous lidocaine injectionAlso: IV lidocainePatients 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. | Drug | Intravenous lidocaine injection group |
| Intravenous normal saline injectionAlso: IV salineThe patients in Group C (placebo control group) received normal saline intravenous injection | Drug | Placebo control group |
Primary outcome
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.
11 secondary outcomes
visual analogue scale 12 hour
Time frame: Post op 12 hour
visual analogue scale 24hour
Time frame: Post op 24 hour
Visual analogue scale 48hour
Time frame: Post Op 48hour
Opioid consumption 4hour
Time frame: Post Op 4hour
Opioid consumption 24hour
Time frame: Post op 24 hour
Opioid consumption 12 hour
Time frame: Post Op 12 hour
Opioid consumption 48hour
Time frame: Post Op 48 hour
FPB 4 hour
Time frame: Post Op 4 hour
FPB 12 hour
Time frame: post op 12 hour
FPB 24 hour
Time frame: Post Op 24 hour
FPB 48 hour
Time frame: Post Op 48 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Derived from this study: PubMed 24216403Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Kang, Ph.D., study chair
Chung-Ang University Hospital
Young-Baeg Kim, Ph.D. study director
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous lidocaine injection and Intravenous normal saline injection in people with Postoperative Pain, run by Chung-Ang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postopeartive pain measured using Visual analogue scale at postoperative 4hour (time frame: post op 4hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.