NCT01059331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

January 28, 2010

Last Update Submit

March 20, 2014

Conditions

Living Donors

Keywords

Kidney

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)

    Daily troughout the hospital stay, approx. 6 days

Secondary Outcomes (1)

  • Sedation and cognitive function

    Daily troughout the hospital stay, approx. 6 days

Study Arms (2)

Pregabalin

EXPERIMENTAL
Drug: Pregabalin

Sugar pill

PLACEBO COMPARATOR
Drug: Sugar pill

Interventions

PregabalinDRUG

150 mg x 2 daily for 2 days

Also known as: Lyrica ATC-nr.: NO3A X 160
Pregabalin
Sugar pillDRUG

1 tablet x 2 daily, for 2 days

Sugar pill

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18, \< 75 years
  • healthy patients accepted for laparoscopic living donor nephrectomy

You may not qualify if:

  • not familiar to the Norwegian language (spoken and written)
  • allergic to one or more of the medication given in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Universitetssykehus, Rikshospitalet

Oslo, N-0027, Norway

Location

Related Publications (5)

  • Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.

    PMID: 17513656BACKGROUND

  • Mathiesen O, Jacobsen LS, Holm HE, Randall S, Adamiec-Malmstroem L, Graungaard BK, Holst PE, Hilsted KL, Dahl JB. Pregabalin and dexamethasone for postoperative pain control: a randomized controlled study in hip arthroplasty. Br J Anaesth. 2008 Oct;101(4):535-41. doi: 10.1093/bja/aen215. Epub 2008 Jul 23.

    PMID: 18653493BACKGROUND

  • Agarwal A, Gautam S, Gupta D, Agarwal S, Singh PK, Singh U. Evaluation of a single preoperative dose of pregabalin for attenuation of postoperative pain after laparoscopic cholecystectomy. Br J Anaesth. 2008 Nov;101(5):700-4. doi: 10.1093/bja/aen244. Epub 2008 Aug 20.

    PMID: 18716003BACKGROUND

  • Jokela R, Ahonen J, Tallgren M, Haanpaa M, Korttila K. A randomized controlled trial of perioperative administration of pregabalin for pain after laparoscopic hysterectomy. Pain. 2008 Jan;134(1-2):106-12. doi: 10.1016/j.pain.2007.04.002. Epub 2007 May 15.

    PMID: 17507163BACKGROUND

  • Gilron I. Gabapentin and pregabalin for chronic neuropathic and early postsurgical pain: current evidence and future directions. Curr Opin Anaesthesiol. 2007 Oct;20(5):456-72. doi: 10.1097/ACO.0b013e3282effaa7.

    PMID: 17873599BACKGROUND

MeSH Terms

Interventions

PregabalinSugars

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Study Officials

  • Audun Stubhaug, dr.med.

    Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cand.med.

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

NO(1)