Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- klonidin
- Conditions
- Pre- and Postoperative Analgesia
- Sponsor
- Umeå University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- postoperative mobilisation index
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus, shorten the hospital stay and rehabilitation of the patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •all patients in ASA score I - III, planned to be treated with open radical nephrectomy or nephron-sparing surgery having renal cell carcinoma
Exclusion Criteria
- •patients in ASA score IV-V,
- •patients with advanced tumour thrombus in vena cava inferior,
- •patients with high risk for bleeding
- •patients with previous chronic pain symptoms
- •patients having drug abuse
- •patients having cognitive deficiencies or dementia disease
- •patients with any contraindication of either spinal or epidural anesthesia
- •patients younger than 18 years and pregnant woman
- •patients having a weight less than 45 kg or weight over 120 kg
Arms & Interventions
Spinal anesthesia
The drugs used in the spinal injection are: 12 mg bupivacain, 160 ug morfin och klonidin( \< 60 years 75 ug, 60 - 85 years old 60 ug and older than 85 years 45 ug)
Intervention: klonidin
Epidural anesthesia
Epidural anesthesia patients group gets an epidural catheter at level Th 8- 10 with per- and postoperative infusion with a routine mixture of: bupivacain 1 mg/ml, fentanyl 1 ug/ml, and adrenalin 1 ug/ml) until termination.
Intervention: epidural anesthesia
Outcomes
Primary Outcomes
postoperative mobilisation index
Time Frame: within the first 30 days (plus or minus 5 days) after surgery
Using a number of variables an index of mobilisation has been created; eg pain (10 graded scale), malaise, intravenous substitution, eating in dining room, Walking outside ward room, passage of stool, carrying urinary bladder catheter, can mobilise out of bed without help
Secondary Outcomes
- time of hospitalization(within the first 15 days after surgery)