Clinical trial NCT01059331: Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy
Official title: Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Living Donors
Keywords: Kidney
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)
timeFrame: Daily troughout the hospital stay, approx. 6 days
Secondary outcomes:
measure: Sedation and cognitive function
timeFrame: Daily troughout the hospital stay, approx. 6 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Rikshospitalet
Study officials:
affiliation: Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen
name: Audun Stubhaug, dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.