Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

NCT ID: NCT01059331

Last Updated: 2014-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Living Donors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pregabalin

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

150 mg x 2 daily for 2 days

Sugar pill

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

1 tablet x 2 daily, for 2 days

Interventions

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Pregabalin

150 mg x 2 daily for 2 days

Intervention Type DRUG

Sugar pill

1 tablet x 2 daily, for 2 days

Intervention Type DRUG

Other Intervention Names

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Lyrica ATC-nr.: NO3A X 160

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Myhre

cand.med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Audun Stubhaug, dr.med.

Role: PRINCIPAL_INVESTIGATOR

Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen

Locations

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Oslo Universitetssykehus, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 17513656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18653493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18716003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17507163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17873599 (View on PubMed)

Other Identifiers

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2009/1286-1

Identifier Type: -

Identifier Source: org_study_id

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