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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 (ASA)

U

Umeå University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Pre- and Postoperative Analgesia
Spinal Anesthesia
Renal Cell Carcinoma

Treatments

Drug: klonidin
Drug: epidural anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT02030717
Dnr 151:2010/81099
2008-001491-77 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Spinal anesthesia
Experimental group
Description:
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)
Treatment:
Drug: klonidin
Epidural anesthesia
Active Comparator group
Description:
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.
Treatment:
Drug: epidural anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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