Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059331
Recruitment Status : Completed
First Posted : January 29, 2010
Last Update Posted : March 21, 2014
Information provided by (Responsible Party):
Marianne Myhre, Oslo University Hospital

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
Living Donors Drug: Pregabalin Drug: Sugar pill Phase 4

Study Type : Interventional  (Clinical Trial)
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 : February 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin
U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. Sedation and cognitive function [ Time Frame: Daily troughout the hospital stay, approx. 6 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059331

Oslo Universitetssykehus, Rikshospitalet
Oslo, Norway, N-0027
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Audun Stubhaug, Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen

Responsible Party: Marianne Myhre,, Oslo University Hospital Identifier: NCT01059331     History of Changes
Other Study ID Numbers: 2009/1286-1
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: March 21, 2014
Last Verified: March 2014

Keywords provided by Marianne Myhre, Oslo University Hospital:

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs