An interventional study of The intrathecal morphine injection and The intravenous patient-controlled analgesia in Renal Cell Carcinoma, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-03.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.
The open nephrectomy is the treatment of choice for live donor kidney transplantation and renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A single dose of intrathecal morphine(ITM) has been used for the postoperative pain of prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for open nephrectomy has not been studied. Therefore, this prospective, randomized study will evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient controlled analgesia(IV-PCA), comparing to IV-PCA alone.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 46 is close to the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
Drug: The intrathecal morphine injection · Drug: The intravenous patient-controlled analgesia · Drug: Demerol on demand
The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously.
Drug: The intravenous patient-controlled analgesia · Drug: Demerol on demand
A single injection of morphine intrathecally
The intravenous injection of morphine using the patient-controlled analgesia machine
Demerol 25 mg intravenously when pain scores more than 5.
The evaluation of pain at 24 hours after surgery
The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale.
Time frame: at postoperatively 24 hours
The consumption of analgesics
The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.
Time frame: at postoperatively 24 hours
The consumption of intraoperative opioids
The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.
Time frame: From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours
The side effects of opioids after surgery
Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded.
Time frame: During 72 hours after the end of surgery
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital