A Phase 2 interventional study of Ropivacaine and Morphine in Nephrectomy and Analgesia, sponsored by Asklepieion Voulas General Hospital. Completed at 1 site in Greece. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Treatment
60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.
Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thoracic paravertebral block using ropivacaine
Drug: Ropivacaine
Morphine IV
Drug: Morphine
Paravertebral block using ropivacaine preoperatively and postoperatively
Morphine intraoperatively and postoperatively
Postoperative pain
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Time frame: 48 hours
Oxidative stress - lactic acid (mmol/L)
Time frame: 24 hours
Oxidative stress - superoxide dismutase (units/ml)
Time frame: 24 hours
Oxidative stress - malondialdehyde (nmol/mg protein)
Time frame: 24 hours
Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)
Time frame: 24 hours
Complications
Time frame: 48 hours
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Time frame: 48 hours
Patient mobilization
Patient reporting time of first standing to the side of the bed
Time frame: 7 days
Intestinal function
Time of first passing of rectal gas, reported by the patient
Time frame: 7 days
Chronic pain
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ropivacaine · Morphine
Agnosia
Asklepieion Voulas General Hospital