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Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Marianne Myhre, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01059331
First received: January 28, 2010
Last updated: February 16, 2012
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sedation and cognitive function [ Time Frame: Daily troughout the hospital stay, approx. 6 days ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: February 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 28, 2010
Last Updated: February 16, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Data Protection Authority
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Kidney

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 16, 2013