Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

Living Donors Clinical Trial

Official title:

Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059331
• Other study ID #: 2009/1286-1
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2010
• Last updated: March 20, 2014
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Data Protection AuthorityNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Living Donors

Intervention

Drug:
• Pregabalin
150 mg x 2 daily for 2 days
• Sugar pill
1 tablet x 2 daily, for 2 days

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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. — View 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. Review. — View Citation

Jokela R, Ahonen J, Tallgren M, Haanpää 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. Epub 2007 May 15. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)		Daily troughout the hospital stay, approx. 6 days	No
Secondary	Sedation and cognitive function		Daily troughout the hospital stay, approx. 6 days	No