Colorectal SurgeryNCT02012244
Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer
A study testing fentanyl-based analgesia and local anesthetic wound infiltration-based anlagesia in people with Colorectal Surgery, run by Severance Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- fentanyl-based analgesia and local anesthetic wound infiltration-based anlagesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-III
- 20-80 years old
- elective laparoscopic colorectal surgery for cancer
Who cannot join
- drug allergy
- significant renal or hepatic impairment
- sign of infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Sedoul
About this study
The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery
- Conditions
- Colorectal Surgery
- Being tested
- fentanyl-based analgesia, local anesthetic wound infiltration-based anlagesia
- Keywords
- analgesia; colorectal surgery; immunity; local anesthetics; opioids
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl-based analgesiaDrug
fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour
local anesthetic wound infiltration-based anlagesiaDrug
continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour
| Study group | Role | What they receive |
|---|---|---|
| fentanyl-based analgesia | Experimental | fentanyl intravenous patient-controlled analgesia + additional pethidine Receives: Drug: fentanyl-based analgesia |
| local anesthetic wound infiltration-based anlagesia | Experimental | continuous wound inflitration with ropivacaine + tramadol intravenous patient-controlled analgesia + additional ketorolac or propacetamol Receives: Drug: local anesthetic wound infiltration-based anlagesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
NK cell activity
NK cell activity : preoperation, POD 1, POD 2
Measured: 48 hours
IL-2
IL-2 level : preoperation, POD 1, POD 2
Measured: 48 hours
Secondary outcomes (1)
Complication and recurrence
Postoperative complication, recurrence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2015
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 Colorectal SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012244
- Sponsor's protocol ID
- 4-2013-0044
- Status last verified
- Jan 2016
- First submitted
- 7 Dec 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Nunez-Rodriguez E, Zhang H, Sah D, Cata JP. Intersection Between Local Anesthetics and Cancer Biology: What Now? Where Are We Going? Adv Biol (Weinh). 2025 Oct;9(10):e00122. doi: 10.1002/adbi.202500122. Epub 2025 Aug 7.
PubMed 40772525
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02012244
- Acronym / sponsor ID
- 4-2013-0044
- Conditions
- Colorectal Surgery
- Keywords
- analgesia; colorectal surgery; immunity; local anesthetics; opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Dec 2013 (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.
The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fentanyl-based analgesia | Experimental | Drug: fentanyl-based analgesiafentanyl intravenous patient-controlled analgesia + additional pethidine |
| local anesthetic wound infiltration-based anlagesia | Experimental | Drug: local anesthetic wound infiltration-based anlagesiacontinuous wound inflitration with ropivacaine + tramadol intravenous patient-controlled analgesia + additional ketorolac or propacetamol |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA class I-III
- 20-80 years old
- elective laparoscopic colorectal surgery for cancer
Key exclusion criteria (3 listed)
- drug allergy
- significant renal or hepatic impairment
- sign of infection
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 |
|---|---|---|
| fentanyl-based analgesiafentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour | Drug | fentanyl-based analgesia |
| local anesthetic wound infiltration-based anlagesiacontinuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour | Drug | local anesthetic wound infiltration-based anlagesia |
Primary outcome
NK cell activity
Time frame: 48 hours
NK cell activity : preoperation, POD 1, POD 2
IL-2
Time frame: 48 hours
IL-2 level : preoperation, POD 1, POD 2
1 secondary outcome
Complication and recurrence
Time frame: 1 year
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 12 Jan 2016.
- Derived from this study: PubMed 40772525Nunez-Rodriguez E, Zhang H, Sah D, Cata JP. Intersection Between Local Anesthetics and Cancer Biology: What Now? Where Are We Going? Adv Biol (Weinh). 2025 Oct;9(10):e00122. doi: 10.1002/adbi.202500122. Epub 2025 Aug 7.
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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.
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 fentanyl-based analgesia and local anesthetic wound infiltration-based anlagesia in people with Colorectal Surgery, run by Severance 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 3 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 12 Jan 2016. 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 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?
NK cell activity (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 NCT02012244, 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 12 Jan 2016.