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A single centre, parallel group, pilot study to investigate the effect of opioids on immunomarkers using gene expression profiling. - Opioid Immunosuppression Study

A single centre, parallel group, pilot study to investigate the effect of opioids on immunomarkers using gene expression profiling. - Opioid Immunosuppression Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004071-34-GB
Enrollment
45
Registered
2006-10-09
Start date
2009-01-14
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study is not looking at any disease process

Interventions

Trade Name: Oxycodone Product Name: Oxycodone Pharmaceutical Form: Intravenous infusion Trade Name: Morphine sulphate Product Name: Morphine sulphate Pharmaceutical Form: Intravenous infusion Trade

Sponsors

Queen Mary, University of London (QMUL)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 18 years and above. Patients who are ASA 1-3 Patients must be inpatients Patients who are scheduled for elective gynaecological surgery (via a Pfannenstiel abdominal) incision under general anaesthesia Patient has given written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who are allergic to morphine, oxycodone or bupivicaine Patients with a history of anaesthetic complications Patients with a history of substance abuse Patients who have been on long-term opioid therapy, or have taken strong opioids within the last one month Patients who have undergone surgery or received general anaesthesia within the last month Patients who have received blood transfusion in last month Patients who have a history of immune or haematological/bone marrow disorder Known HIV-positive patients Patients with any contra-indication to epidural analgesia (e.g. back surgery, clotting abnormality, local infection, refusal ) Patients having laparoscopic surgery Patients who have participated in another study in the past month.

Design outcomes

Primary

MeasureTime frame
Main Objective: The main objective is to examine the role of the tissue microenvironment and immune system specifically investiagating differences in CD4, CD8 and NK cells beween morphine, oxycodone and epidural treatment groups.;Secondary Objective: The results of this study will allow us to design a long-term outcome study to measure the effect of different opioids on metatstic rate after surgery for bowel cancer.;Primary end point(s): The primary objective of the study is to investigate the effect of opioids, morphine and oxycodone on immune pathways associated with immunosuppression in patients undergoing surgery under general anaesthesia, specifically CD4, CD8 and NK cells. The results of this study will allow us to design a long-term outcome study to measure the effect of different opioids on metatasis rate after surgery for bowel cancer

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026