The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy
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Purpose
This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy.
A total of 83 patients will be randomized into one of three groups (group C or group I or group P) 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 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc.
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 2, 4, 8, 12, 24, 48 hours postoperatively.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Pain |
Drug: Intravenous lidocaine injection Drug: Intraperitoneal lidocaine irrigation group 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: | Comparison of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation for Effective Pain Relief After Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-blind, Placebo-controlled Study |
- Postoperative pain measuring using Visual analogue scale at postoperative 2hour [ Time Frame: Post op 2 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, 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 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, 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.
- Visual analogue scale 8hour [ 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, 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 8hour.
- Visual analogue scale 12 hour [ Time Frame: Post op 12hour ] [ Designated as safety issue: Yes ]
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 12hour.
- visual analogue scale 24hour [ Time Frame: Post op 24hour ] [ Designated as safety issue: No ]
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 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, 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 48hour.
- Opioid consumption 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. 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 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 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.
- Opioid consumption 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. 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 8hour will be measured.
- Opioid consumption 12 hout [ 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. 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 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 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 24hour will be measured.
- Opioid consumption 48hour [ 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. 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 48hour will be measured.
- FPB 2 hour [ 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 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 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 24 hour [ 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: | 83 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 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
|
|
Active Comparator: Intraperitoneal lidocaine irrigation group
Patients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc.
|
Drug: Intraperitoneal lidocaine irrigation group
Patients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc. 50cc of irrigation fluid will be spread below diaphragm and 50cc of irrigation fluid will be spread around the gall bladder.
Other Name: IP lidocaine
|
|
Placebo Comparator: Intravenous normal saline group
The 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 normal saline
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Laparoscopic cholecystectomy
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 | |
| Hyun Kang | 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: | NCT01608373 History of Changes |
| Other Study ID Numbers: | ChungAngUH4 |
| 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 Intraperitoneum Laparoscopic cholecystectomy |
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 June 17, 2013