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Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01059331
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
34
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to investigate if perioperative administration of pregabalin vil reduce postoperative pain and the postoperative need for intravenous opioids compared with todays standard treatment which consist of paracetamol, corticoids and ketobemidone.

In addition potential sideeffects as sedation and effect on cognitive function will be recorded.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pregabalin

Drug: Pregabalin
150 mg x 2 daily for 2 days
Other Names:
  • Lyrica ATC-nr.: NO3A X 160

    		•
    Placebo Comparator: Sugar pill

    Drug: Sugar pill
    1 tablet x 2 daily, for 2 days

    Outcome Measures

    Primary Outcome Measures

    1. Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS) [Daily troughout the hospital stay, approx. 6 days]

    Secondary Outcome Measures

    1. Sedation and cognitive function [Daily troughout the hospital stay, approx. 6 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18, < 75 years

    • healthy patients accepted for laparoscopic living donor nephrectomy

    Exclusion Criteria:

    • not familiar to the Norwegian language (spoken and written)

    • allergic to one or more of the medication given in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo Universitetssykehus, Rikshospitalet Oslo Norway N-0027

    Sponsors and Collaborators

    • Oslo University Hospital

    Investigators

    • Principal Investigator: Audun Stubhaug, dr.med., Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marianne Myhre, cand.med., Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT01059331
    Other Study ID Numbers:
    • 2009/1286-1
    First Posted:
    Jan 29, 2010
    Last Update Posted:
    Mar 21, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Marianne Myhre, cand.med., Oslo University Hospital
    Kidney
    Additional relevant MeSH terms:
    Pregabalin

    Study Results

    No Results Posted as of Mar 21, 2014