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

Phase 1

• Conditions: This study is not looking at any disease process

• Registration Number: EUCTR2006-004071-34-GB
• Lead Sponsor: Queen Mary, University of London (QMUL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-09
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 45

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified