CompletedNCT01059331Updated Mar 21, 2014

Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

A Phase 4 interventional study of Pregabalin and Sugar pill in Living Donors, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-03-21.

Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Living Donors

Keywords

Kidney

In context

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 80 participants (actual)

Study arms

Experimental
Pregabalin
Drug: Pregabalin
Placebo comparator
Sugar pill
Drug: Sugar pill

Interventions

DrugPregabalin
150 mg x 2 daily for 2 days
Also known as: Lyrica ATC-nr.: NO3A X 160
DrugSugar pill
1 tablet x 2 daily, for 2 days

What researchers measure

Primary outcomes

Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)
Time frame: Daily troughout the hospital stay, approx. 6 days

Secondary outcomes

Sedation and cognitive function
Time frame: Daily troughout the hospital stay, approx. 6 days

Study locations

1 site

Oslo Universitetssykehus, Rikshospitalet
Oslo, N-0027, Norway

References and documents

Publications

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. PubMed 17513656 ↗
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. PubMed 18653493 ↗
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. PubMed 18716003 ↗
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. PubMed 17507163 ↗
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. PubMed 17873599 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01059331
Lead sponsor: Oslo University Hospital
Responsible party: Marianne Myhre (cand.med., Oslo University Hospital) — Principal investigator
First posted: Jan 29, 2010
Start date: Feb 2010
Primary completion: Oct 2011
Completion: Dec 2012
Last update: Mar 21, 2014

Study contacts

Audun Stubhaug, dr.med.

principal investigator · Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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