Laparoscopic Colorectal Resection Due to CancerNCT03462836
The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery
A study testing IV ketamine/lidocaine/IV PCA apply and IV PCA only apply in people with Laparoscopic Colorectal Resection Due to Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Traditionally, pain control methods based on narcotic analgesics have been used to control severe pain after surgery, but this has resulted in side effects such as vomiting, constipation, dizziness, mental confusion due to drugs, and respiratory depression. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Laparoscopic Colorectal Resection Due to Cancer
- What is being tested?
- IV ketamine/lidocaine/IV PCA apply and IV PCA only apply
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2019to 28 Sep 2021
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic colorectal resection due to colorectal cancer
- curative, resectable operation
- ASA classification Ⅰ-Ⅲ
Who cannot join
- elective co-operation due to distance metastasis
- preoperative chemo/radiation therapy
- drug allergy to opioid, tramadol, local anesthetics
- MAOi medication (within 14 days of surgery)
- decreased hepatic/renal function
- Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner
- pregnant, lactating women
- palliative surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea
Seoul, 03722
About this study
Traditionally, pain control methods based on narcotic analgesics have been used to control severe pain after surgery, but this has resulted in side effects such as vomiting, constipation, dizziness, mental confusion due to drugs, and respiratory depression. This slowed the recovery of the patient after surgery and increased the duration of hospitalization, which had a negative impact on the patient 's prognosis. In addition, research has been conducted on the use of various painkillers in a variety of ways over the past decade to reduce the dose of narcotic analgesics and to increase the effectiveness of pain control, since studies of anesthetics and narcotic analgesics have shown immunosuppressive effects.
This study investigate the effect of multimodal analgesics for postoperative pain control on immune function amd prognosis in patients undergoing laparoscopic colorectal cancer resection.
- Being tested
- IV ketamine/lidocaine/IV PCA apply, IV PCA only apply
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ketamine/lidocaine/IV PCA applyDrug
In the MA group, 1.0 mg / kg of ketamine is diluted to a total volume of 10 ml. Slowly apply for 1 minute during surgical drape. 1 mg / kg of Lidocaine is loaded at the beginning of surgery. Lidocaine 1.5 mg / kg / hr is administered until the end of the operation.
IV PCA only applyDrug
IV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| IV ketamine/lidocaine/IV PCA (MA) group | Experimental | In addition to basic anesthetic methods, multimodal analgesia with IV ketamine, lidocaine and IV PCA apply Receives: Drug: IV ketamine/lidocaine/IV PCA apply |
| IV PCA only (CA) group | Active comparator | In addition to basic anesthetic methods, only IC PCA apply for pain control Receives: Drug: IV PCA only apply |
What is being measured
The primary outcome is the main question the study is designed to answer.
natural killer cell cytotoxicity
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Measured: postoperative day #3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startApr 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion28 Sep 2021 (estimated)
Why it stopped: The results of the primary endpoints of this study are expected to be difficult to identify, thus canceling the study to readjust the study plan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Colorectal Resection Due to CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462836
- Sponsor's protocol ID
- 4-2017-0773
- Status last verified
- Jul 2019
- First submitted
- 6 Feb 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Optimizing Post-operative Pain Management With Multi Modal Analgesia on Immune Suppression and Oncologic Outcome in Patients Undergoing Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03462836
- Acronym / sponsor ID
- 4-2017-0773
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The results of the primary endpoints of this study are expected to be difficult to identify, thus canceling the study to readjust the study plan.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 28 Sep 2021 (estimated)
- First posted
- 13 Mar 2018 (actual)
- 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.
Traditionally, pain control methods based on narcotic analgesics have been used to control severe pain after surgery, but this has resulted in side effects such as vomiting, constipation, dizziness, mental confusion due to drugs, and respiratory depression. This slowed the recovery of the patient after surgery and increased the duration of hospitalization, which had a negative impact on the patient 's prognosis. In addition, research has been conducted on the use of various painkillers in a variety of ways over the past decade to reduce the dose of narcotic analgesics and to increase the effectiveness of pain control, since studies of anesthetics and narcotic analgesics have shown immunosuppressive effects.
This study investigate the effect of multimodal analgesics for postoperative pain control on immune function amd prognosis in patients undergoing laparoscopic colorectal cancer resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV ketamine/lidocaine/IV PCA (MA) group | Experimental | Drug: IV ketamine/lidocaine/IV PCA applyIn addition to basic anesthetic methods, multimodal analgesia with IV ketamine, lidocaine and IV PCA apply |
| IV PCA only (CA) group | Active comparator | Drug: IV PCA only applyIn addition to basic anesthetic methods, only IC PCA apply for pain control |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective laparoscopic colorectal resection due to colorectal cancer
- curative, resectable operation
- ASA classification Ⅰ-Ⅲ
Key exclusion criteria (8 listed)
- elective co-operation due to distance metastasis
- preoperative chemo/radiation therapy
- drug allergy to opioid, tramadol, local anesthetics
- MAOi medication (within 14 days of surgery)
- decreased hepatic/renal function
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 |
|---|---|---|
| IV ketamine/lidocaine/IV PCA applyIn the MA group, 1.0 mg / kg of ketamine is diluted to a total volume of 10 ml. Slowly apply for 1 minute during surgical drape. 1 mg / kg of Lidocaine is loaded at the beginning of surgery. Lidocaine 1.5 mg / kg / hr is administered until the end of the operation. | Drug | IV ketamine/lidocaine/IV PCA (MA) group |
| IV PCA only applyIV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery. | Drug | IV PCA only (CA) group |
Primary outcome
natural killer cell cytotoxicity
Time frame: postoperative day #3
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV ketamine/lidocaine/IV PCA apply and IV PCA only apply in people with Laparoscopic Colorectal Resection Due to Cancer, run by Yonsei University 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 8 Jul 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
natural killer cell cytotoxicity (time frame: postoperative day #3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2019; AzTrials last refreshed its copy on 5 Nov 2026.