Persistent Postoperative Pain Incidence With Gabapentin Used
NCT ID: NCT02693821
Last Updated: 2023-02-06
Study Results
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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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2015-12-31
2022-06-30
Brief Summary
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Detailed Description
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Its main objective will be to evaluate the pre and postoperative Gabapentin efficiency in orally doses and long term used of it in order to prevent or decrease persistent postoperative pain (PPP) in surgeries with high incidence of it (Pain). Patients will be randomly divided in two branches; one of them will take 600 mg of Gabapentin twice a day and the other group will take Placebo (twice a day also).
Both groups of patients will have to take one pill the day before the surgery (300 mg) and other pill on the surgery day (300mg). After that, the patients will have to continue this treatment during 30 days (two doses per day of Gabapentin or placebo).
After the surgery and after taking the second pill, it will be evaluated:
postoperative sharp pain, sickness, vomiting, sedation and adverse effects.
Patients will be evaluated in the pain treatment office (consulting room) the following times:
1. 30 days after the surgery. (taking drugs suspended)
2. 3 month after the surgery.
3. 6 months after the surgery.
4. 12 months after the surgery
This monitoring treatment will be done in order to evaluate the presence or absence of persistent postoperative pain (PPP).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
La analgesia será la convencional para cada cirugía y se continuará con el uso de catéteres epidurales, para analgesia en aquellas intervenciones donde su aplicación sea habitual.
Study Groups
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Gabapentin
300mg of Gabapentin per day (two doses), orally during 30 days
Gabapentin
gabapentin 300 mg per day, orally during 30 days
Placebo
300mg of Placebo per day (two doses), orally during 30 days
Placebo
Placebo 300 mg per day, orally during 30 days
Interventions
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Gabapentin
gabapentin 300 mg per day, orally during 30 days
Placebo
Placebo 300 mg per day, orally during 30 days
Eligibility Criteria
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Inclusion Criteria
* Patients that had already signed the informed consent.
* Patients aged between 21 and 75.
* ASA I - II \_ III (Classification system that the American Society of Anesthesiologists (ASA) uses to estimate the anesthesiology risk that patients may suffer)
* BMI, not more than 35 Kg/m2.
Exclusion Criteria
* Patients that suffer liver and renal failure (plasma creatinine over 1.5 mg/ml or creatinine clearance less than 60 ml/min),heart failure or neurological dysfunction.
* Diabetic patients
* Gabapentine allergic patients
21 Years
75 Years
ALL
Yes
Sponsors
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Hospital Italiano de Buenos Aires
OTHER
Responsible Party
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FRANCISCO CARLOS BONOFIGLIO
Anesthesiology Doctor
Principal Investigators
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Francisco FB Bonofiglio, Doctor
Role: STUDY_DIRECTOR
Hospital Italiano de Buenos Aires
Locations
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Sofía Konekny
Almagro, Buenos Aires, Argentina
Countries
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References
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Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.
Werner MU, Kongsgaard UE. I. Defining persistent post-surgical pain: is an update required? Br J Anaesth. 2014 Jul;113(1):1-4. doi: 10.1093/bja/aeu012. Epub 2014 Feb 18. No abstract available.
Borsook D, Kussman BD, George E, Becerra LR, Burke DW. Surgically induced neuropathic pain: understanding the perioperative process. Ann Surg. 2013 Mar;257(3):403-12. doi: 10.1097/SLA.0b013e3182701a7b.
Crombie IK, Davies HT, Macrae WA. Cut and thrust: antecedent surgery and trauma among patients attending a chronic pain clinic. Pain. 1998 May;76(1-2):167-71.
Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
Gilron I, Watson CP, Cahill CM, Moulin DE. Neuropathic pain: a practical guide for the clinician. CMAJ. 2006 Aug 1;175(3):265-75. doi: 10.1503/cmaj.060146.
Matthews EA, Dickenson AH. Effects of spinally delivered N- and P-type voltage-dependent calcium channel antagonists on dorsal horn neuronal responses in a rat model of neuropathy. Pain. 2001 May;92(1-2):235-46. doi: 10.1016/s0304-3959(01)00255-x.
Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002 Nov-Dec;18(6):350-4. doi: 10.1097/00002508-200211000-00002.
Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.
Backonja MM, Galer BS. Pain assessment and evaluation of patients who have neuropathic pain. Neurol Clin. 1998 Nov;16(4):775-90. doi: 10.1016/s0733-8619(05)70097-9.
Lavand'homme P. From preemptive to preventive analgesia: time to reconsider the role of perioperative peripheral nerve blocks? Reg Anesth Pain Med. 2011 Jan-Feb;36(1):4-6. doi: 10.1097/AAP.0b013e31820305b8. No abstract available.
Rosner H, Rubin L, Kestenbaum A. Gabapentin adjunctive therapy in neuropathic pain states. Clin J Pain. 1996 Mar;12(1):56-8. doi: 10.1097/00002508-199603000-00010.
Dauri M, Faria S, Gatti A, Celidonio L, Carpenedo R, Sabato AF. Gabapentin and pregabalin for the acute post-operative pain management. A systematic-narrative review of the recent clinical evidences. Curr Drug Targets. 2009 Aug;10(8):716-33. doi: 10.2174/138945009788982513.
Miller A, Price G. Gabapentin toxicity in renal failure: the importance of dose adjustment. Pain Med. 2009 Jan;10(1):190-2. doi: 10.1111/j.1526-4637.2008.00492.x. Epub 2008 Aug 18.
Other Identifiers
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2575
Identifier Type: -
Identifier Source: org_study_id
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