Postoperative PainPhase 4NCT01608373
The Effect of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation on Pain After Laparoscopic Cholecystectomy
A Phase 4 study testing Intravenous lidocaine injection, Intraperitoneal lidocaine irrigation group 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 comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intravenous lidocaine injection, Intraperitoneal lidocaine irrigation group 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
- 83 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Jul 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic cholecystectomy
Who cannot join
- mental change
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hyun Kang
Seoul
SeongDeok Kim, M.D. & Ph.D., 82-2-6299-2571, ksdeok@cau.ac.kr
Hyun Kang, Ph.D.
About this study
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
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.
Read more
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.
- Conditions
- Postoperative Pain
- Being tested
- Intravenous lidocaine injection, Intraperitoneal lidocaine irrigation group, Intravenous normal saline injection
- Keywords
- Pain, Lidocaine, Intravenous, Intraperitoneum, Laparoscopic cholecystectomy
- 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
Intraperitoneal lidocaine irrigation groupDrug
Also called IP lidocaine
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.
Intravenous normal saline injectionDrug
Also called IV normal 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 |
| Intraperitoneal lidocaine irrigation group | Active comparator | Patients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc. Receives: Drug: Intraperitoneal lidocaine irrigation group |
| Intravenous normal saline group | Placebo comparator | The 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.
Postoperative pain measuring using Visual analogue scale at postoperative 2hour
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.
Measured: Post op 2 hour
Secondary outcomes (17)
Visual analogue scale 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 4 hour
Visual analogue scale 8hour
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.
Measured: Post op 8 hour
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 12hour.
Measured: Post op 12hour
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 24hour.
Measured: Post op 24hour
Visual analogue scale 48 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 48hour.
Measured: Post op 48hour
Opioid consumption 2hour
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.
Measured: Post op 2 hour
Opioid consumption 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. 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 4 hour
Opioid consumption 8 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 fom immediately after operation to post op 8hour will be measured.
Measured: Post op 8 hour
Opioid consumption 12 hout
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.
Measured: Post op 12 hour
Opioid consumption 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 fom immediately after operation to post op 24hour will be measured.
Measured: Post op 24 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 fom immediately after operation to post op 48hour will be measured.
Measured: Post op 48 hour
FPB 2 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 2 hour will be measured.
Measured: Post op 2 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 8 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 8 hour will be measured.
Measured: Post op 8 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 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.
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 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.
Measured: Post op 24hour
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 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.
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 posted31 May 2012 (estimated)
- Study startJul 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
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
- 83 participants (estimated)
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 HospitalEun Jin Ahn, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608373
- Sponsor's protocol ID
- ChungAngUH4
- Status last verified
- Jul 2011
- First submitted
- 26 May 2012
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang SY, Kang H, Choi GJ, Shin HY, Baek CW, Jung YH, Choi YS. Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. J Int Med Res. 2014 Apr;42(2):307-19. doi: 10.1177/0300060513505493.
PubMed 24648482
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
- Comparison of Intravenous Lidocaine and Intraperitoneal Lidocaine Irrigation for Effective Pain Relief After Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01608373
- Acronym / sponsor ID
- ChungAngUH4
- Conditions
- Postoperative Pain
- Keywords
- Pain, Lidocaine, Intravenous, Intraperitoneum, Laparoscopic cholecystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 May 2012 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| 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. |
| Intraperitoneal lidocaine irrigation group | Active comparator | Drug: Intraperitoneal lidocaine irrigation groupPatients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc. |
| Intravenous normal saline group | Placebo comparator | Drug: Intravenous normal saline injectionThe patients in Group C (placebo control group) received normal saline intravenous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Laparoscopic cholecystectomy
Key exclusion criteria (2 listed)
- mental change
- allergy to local anesthetics
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 |
| Intraperitoneal lidocaine irrigation groupAlso: IP lidocainePatients 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. | Drug | Intraperitoneal lidocaine irrigation group |
| Intravenous normal saline injectionAlso: IV normal salineThe patients in Group C (placebo control group) received normal saline intravenous injection | Drug | Intravenous normal saline group |
Primary outcome
Postoperative pain measuring using Visual analogue scale at postoperative 2hour
Time frame: Post op 2 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 2hour.
17 secondary outcomes
Visual analogue scale 4hour
Time frame: Post op 4 hour
Visual analogue scale 8hour
Time frame: Post op 8 hour
Visual analogue scale 12 hour
Time frame: Post op 12hour
visual analogue scale 24hour
Time frame: Post op 24hour
Visual analogue scale 48 hour
Time frame: Post op 48hour
Opioid consumption 2hour
Time frame: Post op 2 hour
Opioid consumption 4 hour
Time frame: Post op 4 hour
Opioid consumption 8 hour
Time frame: Post op 8 hour
Opioid consumption 12 hout
Time frame: Post op 12 hour
Opioid consumption 24 hour
Time frame: Post op 24 hour
Opioid consumption 48hour
Time frame: Post op 48 hour
FPB 2 hour
Time frame: Post op 2 hour
FPB 4 hour
Time frame: Post op 4 hour
FPB 8 hour
Time frame: Post op 8 hour
FPB 12 hour
Time frame: Post op 12 hour
FPB 24 hour
Time frame: Post op 24hour
FPB 48 hour
Time frame: Post op 48 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Derived from this study: PubMed 24648482Yang SY, Kang H, Choi GJ, Shin HY, Baek CW, Jung YH, Choi YS. Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. J Int Med Res. 2014 Apr;42(2):307-19. doi: 10.1177/0300060513505493.
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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
Eun Jin Ahn principal investigator
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, Intraperitoneal lidocaine irrigation group 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 2 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Kang, Ph.D (82-2-6299-2571, roman00@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain measuring using Visual analogue scale at postoperative 2hour (time frame: Post op 2 hour). 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 NCT01608373, 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.