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

NCT ID: NCT02030717

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pre- and Postoperative Analgesia Spinal Anesthesia Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

klonidin

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

epidural anesthesia

Intervention Type 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

Interventions

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klonidin

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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Umeå

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Borje Ljungberg, MD, PhD

Role: STUDY_CHAIR

Umea University

Locations

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Umea University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

References

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Thurm M, Hultin M, Johansson G, Dahlin BI, Winso O, Ljungberg B. Spinal anaesthesia with clonidine: pain relief and earlier mobilisation after open nephrectomy - a randomised clinical trial. J Int Med Res. 2022 Sep;50(9):3000605221126883. doi: 10.1177/03000605221126883.

Reference Type DERIVED
PMID: 36177827 (View on PubMed)

Other Identifiers

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2008-001491-77

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Dnr 151:2010/81099

Identifier Type: -

Identifier Source: org_study_id

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