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Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059331
First Posted: January 29, 2010
Last Update Posted: March 21, 2014
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.
Information provided by (Responsible Party):
Marianne Myhre, Oslo University Hospital
  Purpose

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 Intervention Phase
Living Donors Drug: Pregabalin Drug: Sugar pill Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Marianne Myhre, Oslo University Hospital:

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

Enrollment: 80
Study Start Date: February 2010
Study Completion Date: December 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01059331


Locations
Norway
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
  More Information

Publications:
Responsible Party: Marianne Myhre, cand.med., Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01059331     History of Changes
Other Study ID Numbers: 2009/1286-1
First Submitted: January 28, 2010
First Posted: January 29, 2010
Last Update Posted: March 21, 2014
Last Verified: March 2014

Keywords provided by Marianne Myhre, Oslo University Hospital:
Kidney

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