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

Renal Cell Carcinoma Clinical Trial

— ASA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030717
• Other study ID #: Dnr 151:2010/81099
• Secondary ID: 2008-001491-77
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 7, 2014
• Last updated: June 3, 2015
• Start date: February 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• klonidin
spinal injection of 12 mg bupivacain,160 ug morfin och klonidin, according to age
• epidural 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

Locations

Country	Name	City	State
Sweden	Umea University Hospital	Umea

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need of rescue analgetics	the total amount of analgetics used besides the spinal infusion or the epidural infusion used	within the first 15 days after surgery	No
Primary	postoperative mobilisation index	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	within the first 30 days (plus or minus 5 days) after surgery	No
Secondary	time of hospitalization	time in hospital after surgery until discharge	within the first 15 days after surgery	No