Persistent Postoperative Pain Incidence With Gabapentin Used

Pain, Postoperative Clinical Trial

— PPP  

Official title:

Persistent Postoperative Pain Incidence With Long Term Perioperative Gabapentin Used

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02693821
• Other study ID #: 2575
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: June 2022

Study information

• Verified date: February 2023
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study's objective will be to evaluate the gabapentine efficiency in orally and long term used after painfully surgeries.

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:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2022
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Gabapentin
gabapentin 300 mg per day, orally during 30 days
• Placebo
Placebo 300 mg per day, orally during 30 days

Locations

Country	Name	City	State
Argentina	Sofía Konekny	Almagro	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2012 Nov 21;308(19):1973. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pain after using gabapentin.	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.	Two years