PainNCT02669186
Effects of Anesthetic Technique on NK Cells
A study testing Bupivacaine + Fentanyl and Bupivacaine in people with Pain and Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The proposed study is a pilot prospective, single-blinded, randomized controlled trial evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural killer cell population size and cytotoxicity in patients undergoing exploratory abdominal laparotomies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anesthesia, Cancer
- What is being tested?
- Bupivacaine + Fentanyl and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to Dec 2025
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 80 years old of either gender
- Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon
- Must be able to have an epidural
Who cannot join
- ASA IV and above
- Intolerance, allergy, or contraindication to use of either fentanyl or bupivacaine.
- Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
- Uncontrolled hypertension (BP > 140/90)
- Cardiac arrhythmias particularly prolonged QT syndrome
- Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
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- Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
- Pregnant or lactating women
- Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
- Chronic renal failure ( creatinine > 2.0 mg/dL)
- Liver failure e.g., active cirrhosis
- Alcohol or substance abuse within in the past 3 months
- Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
- Neuropathic pain
- Chronic opioid consumption (>30mg oxycodone or greater per day)
- Cachexia from any cause
- Systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery
- HIV or other immunosuppressive condition
- Preoperative INR > 1.4 or platelet count < 100
- Sepsis or overlying skin cellulitis at epidural catheter insertion site
- Inability to tolerate/unwillingness to have an epidural catheter for intraoperative/postoperative pain control for any reason, including prior back surgery resulting in distorted anatomy that precludes neuraxial anesthesia.
- Inability to tolerate an epidural solution of either fentanyl or bupivacaine or needs another form of specialized pain control.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity
The proposed study is a pilot prospective, single-blinded, randomized controlled trial evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural killer cell population size and cytotoxicity in patients undergoing exploratory abdominal laparotomies.
- Conditions
- Pain, Anesthesia, Cancer
- Being tested
- Bupivacaine + Fentanyl, Bupivacaine
- Keywords
- analgesia, cancer, natural killer cell, opioid
- Medical subject headings
- Pain, Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine + FentanylDrug
Also called Sublimaze
General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control.
BupivacaineDrug
General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control
| Study group | Role | What they receive |
|---|---|---|
| 'Bupivacaine + Fentanyl' (Opioid Group) | Experimental | Group 1 (opioid group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control. Receives: Drug: Bupivacaine + Fentanyl |
| Bupivacaine (Local Anesthetic Group) | Active comparator | Group 2 (local anesthetic group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural Killer Cell Cytotoxicty
Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start10 Jul 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, MD, PhD, Principal investigator, Program Director, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669186
- Sponsor's protocol ID
- Pro00039201-1
- Status last verified
- Aug 2023
- First submitted
- 6 Oct 2015
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.
PubMed 25009196Beilin B, Shavit Y, Hart J, Mordashov B, Cohn S, Notti I, Bessler H. Effects of anesthesia based on large versus small doses of fentanyl on natural killer cell cytotoxicity in the perioperative period. Anesth Analg. 1996 Mar;82(3):492-7. doi: 10.1097/00000539-199603000-00011.
PubMed 8623949Cata JP, Bauer M, Sokari T, Ramirez MF, Mason D, Plautz G, Kurz A. Effects of surgery, general anesthesia, and perioperative epidural analgesia on the immune function of patients with non-small cell lung cancer. J Clin Anesth. 2013 Jun;25(4):255-62. doi: 10.1016/j.jclinane.2012.12.007. Epub 2013 May 7.
PubMed 23659826
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity
- ClinicalTrials.gov ID
- NCT02669186
- Acronym / sponsor ID
- Pro00039201-1
- Conditions
- Pain, Anesthesia, Cancer
- Keywords
- analgesia, cancer, natural killer cell, opioid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Feb 2016 (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 proposed study is a pilot prospective, single-blinded, randomized controlled trial evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural killer cell population size and cytotoxicity in patients undergoing exploratory abdominal laparotomies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Bupivacaine + Fentanyl' (Opioid Group) | Experimental | Drug: Bupivacaine + FentanylGroup 1 (opioid group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control. |
| Bupivacaine (Local Anesthetic Group) | Active comparator | Drug: BupivacaineGroup 2 (local anesthetic group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 - 80 years old of either gender
- Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon
- Must be able to have an epidural
Key exclusion criteria (22 listed)
- ASA IV and above
- Intolerance, allergy, or contraindication to use of either fentanyl or bupivacaine.
- Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
- Uncontrolled hypertension (BP > 140/90)
- Cardiac arrhythmias particularly prolonged QT syndrome
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 |
|---|---|---|
| Bupivacaine + FentanylAlso: SublimazeGeneral endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control. | Drug | 'Bupivacaine + Fentanyl' (Opioid Group) |
| BupivacaineGeneral endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control | Drug | Bupivacaine (Local Anesthetic Group) |
Primary outcome
Natural Killer Cell Cytotoxicty
Time frame: One Year
Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 25009196Buckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.
- Background: PubMed 8623949Beilin B, Shavit Y, Hart J, Mordashov B, Cohn S, Notti I, Bessler H. Effects of anesthesia based on large versus small doses of fentanyl on natural killer cell cytotoxicity in the perioperative period. Anesth Analg. 1996 Mar;82(3):492-7. doi: 10.1097/00000539-199603000-00011.
- Background: PubMed 23659826Cata JP, Bauer M, Sokari T, Ramirez MF, Mason D, Plautz G, Kurz A. Effects of surgery, general anesthesia, and perioperative epidural analgesia on the immune function of patients with non-small cell lung cancer. J Clin Anesth. 2013 Jun;25(4):255-62. doi: 10.1016/j.jclinane.2012.12.007. Epub 2013 May 7.
- Individual participant dataSharing planned: Undecided
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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.
Roya Yumul, MD, PhD principal investigator
Program Director, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine + Fentanyl and Bupivacaine in people with Pain and Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.
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 22 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 29 Aug 2023. 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 United States. 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?
Results are not available in the source record.
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 Cytotoxicty (time frame: One Year). 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 NCT02669186, which also lists 3 linked publications.
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 29 Aug 2023.