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NCT Number: NCT02030717

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

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.

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Key information

Conditions

Pre- and Postoperative Analgesia Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Cell Carcinoma Spinal Anesthesia Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Umea University Hospital

Umeå, 901 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

klonidin

Drug

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

Other names: Brand name: Duraclon - FDA Apl No (NDA) 020615.

Epidural anesthesia

Drug

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

Primary outcomes

  1. 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

  1. time of hospitalization

    Time frame: within the first 15 days after surgery

    time in hospital after surgery until discharge

Other outcomes

  1. Need of rescue analgetics

    Time frame: within the first 15 days after surgery

    the total amount of analgetics used besides the spinal infusion or the epidural infusion used

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • University Hospital, Umeå

Registry information

Acronym: ASA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2014
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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