Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

March 20, 2014 updated by: Marianne Myhre, Oslo University Hospital

Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, N-0027
        • Oslo Universitetssykehus, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar pill
Drug: Sugar pill
1 tablet x 2 daily, for 2 days
Experimental: Pregabalin
Drug: Pregabalin
150 mg x 2 daily for 2 days
Other Names:
  • Lyrica ATC-nr.: NO3A X 160

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)
Time Frame: Daily troughout the hospital stay, approx. 6 days
Daily troughout the hospital stay, approx. 6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Sedation and cognitive function
Time Frame: Daily troughout the hospital stay, approx. 6 days
Daily troughout the hospital stay, approx. 6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/1286-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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