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Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma

Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02030717
Acronym
ASA
Enrollment
120
Registered
2014-01-08
Start date
2012-02-29
Completion date
2015-05-31
Last updated
2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre- and Postoperative Analgesia, Renal Cell Carcinoma, Spinal Anesthesia

Keywords

Spinal anesthesia, Epidural anesthesia, Klonidin, renal cell carcinoma

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.

Interventions

DRUGklonidin

spinal injection of 12 mg bupivacain,160 ug morfin och klonidin, according to age

DRUGepidural anesthesia

epidural anesthesia: patients get an continuous infusion of a solution with bupivacain 1 mg/ml, fentanyl 1 ug/ml and adrenalin 1 ug/ml

Sponsors

University Hospital, Umeå
CollaboratorOTHER
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative mobilisation indexwithin the first 30 days (plus or minus 5 days) after surgeryUsing 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

MeasureTime frameDescription
time of hospitalizationwithin the first 15 days after surgerytime in hospital after surgery until discharge

Other

MeasureTime frameDescription
Need of rescue analgeticswithin the first 15 days after surgerythe total amount of analgetics used besides the spinal infusion or the epidural infusion used

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026