Living DonorsPhase 4NCT01059331
Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy
A Phase 4 study testing Pregabalin and Sugar pill in people with Living Donors, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Living Donors
- What is being tested?
- Pregabalin and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18, < 75 years
- healthy patients accepted for laparoscopic living donor nephrectomy
Who cannot join
- not familiar to the Norwegian language (spoken and written)
- allergic to one or more of the medication given in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study
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
- Living Donors
- Being tested
- Pregabalin, Sugar pill
- Keywords
- Kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica ATC-nr.: NO3A X 160
150 mg x 2 daily for 2 days
Sugar pillDrug
1 tablet x 2 daily, for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Not described Receives: Drug: Pregabalin |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)
Measured: Daily troughout the hospital stay, approx. 6 days
Secondary outcomes (1)
Sedation and cognitive function
Measured: Daily troughout the hospital stay, approx. 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Living DonorsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Myhre, Oslo University Hospital
- Investigators
- Audun Stubhaug, dr.med., Principal investigator, Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059331
- Sponsor's protocol ID
- 2009/1286-1
- Status last verified
- Mar 2014
- First submitted
- 28 Jan 2010
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 17513656Mathiesen 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 18653493Agarwal 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 18716003Jokela 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 17507163Gilron 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01059331
- Acronym / sponsor ID
- 2009/1286-1
- Conditions
- Living Donors
- Keywords
- Kidney
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin |
| Sugar pill | Placebo comparator | Drug: Sugar pill |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18, < 75 years
- healthy patients accepted for laparoscopic living donor nephrectomy
Key exclusion criteria (2 listed)
- not familiar to the Norwegian language (spoken and written)
- allergic to one or more of the medication given in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: Lyrica ATC-nr.: NO3A X 160150 mg x 2 daily for 2 days | Drug | Pregabalin |
| Sugar pill1 tablet x 2 daily, for 2 days | Drug | Sugar pill |
Primary outcome
Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS)
Time frame: Daily troughout the hospital stay, approx. 6 days
1 secondary outcome
Sedation and cognitive function
Time frame: Daily troughout the hospital stay, approx. 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
- Background: PubMed 17513656Tiippana 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.
- Background: PubMed 18653493Mathiesen 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.
- Background: PubMed 18716003Agarwal 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.
- Background: PubMed 17507163Jokela 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.
- Background: PubMed 17873599Gilron 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.
Related trials for Living Donors
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
RecruitingObservational study
Liver Transplantation for Colorectal Cancer
Colorectal Cancer, Liver Metastasis
Not yet recruiting
Technology-enabled Social Network Intervention to Increase Live Donor Kidney Transplantation
End-Stage Renal Disease, Chronic Kidney Diseases
Enrolling by invitationPhase 4
Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
Postoperative Pain
RecruitingPhase 2
Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue
Liver Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audun Stubhaug, dr.med. principal investigator
Universitetet i Oslo, Rikshospitaelt, Anestesi- og intensivavdelingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin and Sugar pill in people with Living Donors, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption in milligrams Pain Score given as Numeric Rating Scale (NRS) (time frame: Daily troughout the hospital stay, approx. 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01059331, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.