PPP: Persistent Postoperative Pain
Study Details
Study Description
Brief Summary
The study's objective will be to evaluate the gabapentine efficiency in orally and long term used after painfully surgeries.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This study will be: controlled, prospective, randomized and double blind.
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:
-
30 days after the surgery. (taking drugs suspended)
-
3 month after the surgery.
-
6 months after the surgery.
-
12 months after the surgery
This monitoring treatment will be done in order to evaluate the presence or absence of persistent postoperative pain (PPP).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gabapentin 300mg of Gabapentin per day (two doses), orally during 30 days |
Drug: Gabapentin
gabapentin 300 mg per day, orally during 30 days
|
| Placebo Comparator: Placebo 300mg of Placebo per day (two doses), orally during 30 days |
Other: Placebo
Placebo 300 mg per day, orally during 30 days
|
Outcome Measures
Primary Outcome Measures
- Prevalence of pain after using gabapentin. [Two years]
It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients that require persistent painfully surgeries such as breast surgeries (mastectomies and breast implants), herniorrhaphies (not laparoscopical) unilateral or bilateral, amputations of upper and lower limbs and chest surgeries (thoracotomy, thoracoscopy , sternotomies).
-
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:
-
Pregnant women
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sofía Konekny | Almagro | Buenos Aires | Argentina | C1199ABB |
Sponsors and Collaborators
- Hospital Italiano de Buenos Aires
Investigators
- Study Director: Francisco FB Bonofiglio, Doctor, Hospital Italiano de Buenos Aires
Study Documents (Full-Text)
None provided.More Information
Publications
- Backonja MM, Galer BS. Pain assessment and evaluation of patients who have neuropathic pain. Neurol Clin. 1998 Nov;16(4):775-90. Review.
- 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. Review.
- Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-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. Epub 2005 Jan 26.
- 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.
- 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. Review.
- Gärtner 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. Erratum in: JAMA. 2012 Nov 21;308(19):1973.
- Gilron I, Watson CP, Cahill CM, Moulin DE. Neuropathic pain: a practical guide for the clinician. CMAJ. 2006 Aug 1;175(3):265-75. Review.
- Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review.
- 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.
- 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. Review.
- 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.
- 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.
- Rosner H, Rubin L, Kestenbaum A. Gabapentin adjunctive therapy in neuropathic pain states. Clin J Pain. 1996 Mar;12(1):56-8.
- 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. Review.
- 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.
- 2575