The Effect of Intravenous Lidocaine on Pain After Thyroidectomy
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Purpose
This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy.
A total 56 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 normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr.
Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain |
Drug: Intravenous lidocaine injection Drug: Intravenous normal saline injection |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intravenous Lidocaine for Effective Pain Relief After Thyroidectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study |
- Postoperative pain measured using Visual analogue scale at postoperative 2hour [ Time Frame: post op 2hour ] [ Designated as safety issue: No ]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 2hour.
- visual analogue scale 4hour [ Time Frame: post op 4 hour ] [ Designated as safety issue: No ]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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.
- visual analogue scale 8 hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 8hour.
- Visual analogue scale 12hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 12hour.
- visual analogue scale 24hour [ Time Frame: Post op 24 hour ] [ Designated as safety issue: No ]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 24hour.
- visual analogue scale 48 hour [ Time Frame: Post op 48hour ] [ Designated as safety issue: No ]
Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 48hour.
- Opioid consumption 2hour [ Time Frame: post op 2hour ] [ Designated as safety issue: No ]The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ 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 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 2hour will be measured.
- Opioid consumption 4 hour [ Time Frame: Post op 4 hour ] [ Designated as safety issue: No ]The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ 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 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 4hour will be measured
- Opioid consumption 8hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ 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 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 8hour will be measured
- Opioid consumption 12 hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ 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 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 12hour will be measured
- Opioid consumption 24 hour [ Time Frame: Post op 24 hour ] [ Designated as safety issue: No ]The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ 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 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 24hour will be measured
- Opioid consumption 48 hour [ Time Frame: Post op 48 hour ] [ Designated as safety issue: No ]The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ 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 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 48hour will be measured
- FPB 2hour [ Time Frame: Post op 2 hour ] [ Designated as safety issue: No ]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 2 hour will be measured.
- FPB 4hour [ Time Frame: Post op 4 hour ] [ Designated as safety issue: No ]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.
- FPB 8 hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]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 8 hour will be measured.
- FPB 12 hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]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 12 hour will be measured.
- FPB 24hour [ Time Frame: Post op 24hour ] [ Designated as safety issue: No ]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 24 hour will be measured.
- FPB 48 hour [ Time Frame: Post op 48 hour ] [ Designated as safety issue: No ]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 48 hour will be measured.
| Estimated Enrollment: | 56 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Intravenous lidocaine injection group
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.
|
Drug: Intravenous lidocaine injection
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 Name: IV lidocaine
|
|
Placebo Comparator: Placebo control group
Patients in Group C (placebo control group) received normal saline intravenous injection
|
Drug: Intravenous normal saline injection
The patients in Group C (placebo control group) received normal saline intravenous injection
Other Name: IV saline
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Total thyroidectomy
Exclusion Criteria:
- mental change
- allergy to local anesthetics
Contacts and Locations| Contact: Hyun Kang, Ph.D | 82-2-6299-2571 | roman00@naver.com |
| Korea, Republic of | |
| ChungAng University | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: SeongDeok Kim, M.D. & Ph.D. 82-2-6299-2571 ksdeok@cau.ac.kr | |
| Principal Investigator: Hyun Kang, Ph.D. | |
| Sub-Investigator: Eun Jin Ahn | |
| Study Chair: | Hyun Kang, Ph.D | Chungang University Hospital |
| Principal Investigator: | Eun Jin Ahn | Chungang University Hospital |
More Information
No publications provided
| Responsible Party: | Hyun Kang, Assistant professor, Chung-Ang Univerisity Hospital |
| ClinicalTrials.gov Identifier: | NCT01608360 History of Changes |
| Other Study ID Numbers: | ChungAngUH3 |
| Study First Received: | May 26, 2012 |
| Last Updated: | May 30, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Chung-Ang University Hospital:
|
Pain Lidocaine Intravenous Thyroidectomy |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013