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.
Exclusion Criteria:
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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asklepieion Voulas General Hospital