Persistent Postoperative Pain Incidence With Gabapentin Used

NCT02693821 | Completed Phase 4 DMC

• 1 other identifier: 2575
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

Gabapentin; prevention; incidence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gabapentin

EXPERIMENTAL

300mg of Gabapentin per day (two doses), orally during 30 days

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

300mg of Placebo per day (two doses), orally during 30 days

Drug: Placebo

Interventions

Gabapentin DRUG

gabapentin 300 mg per day, orally during 30 days

Gabapentin

Placebo DRUG

Placebo 300 mg per day, orally during 30 days

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Sofía Konekny

Almagro, Buenos Aires, C1199ABB, Argentina

Location

Related Publications (15)

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 18434337 BACKGROUND

• 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.

  PMID: 24554546 BACKGROUND

• 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.

  PMID: 23059501 BACKGROUND

• 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.

  PMID: 9696470 BACKGROUND

• 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.

  PMID: 19903919 BACKGROUND

• 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.

  PMID: 16880448 BACKGROUND

• 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.

  PMID: 11323145 BACKGROUND

• 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.

  PMID: 12441828 BACKGROUND

• 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.

  PMID: 15733628 BACKGROUND

• 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.

  PMID: 9767062 BACKGROUND

• 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.

  PMID: 21455081 BACKGROUND

• 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.

  PMID: 8722736 BACKGROUND

• 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.

  PMID: 19702520 BACKGROUND

• 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.

  PMID: 18721173 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Francisco FB Bonofiglio, Doctor

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cuando el paciente dé su consentimiento, será reclutado y randomizado a un grupo control (recibirá placebo) o a un grupo tratamiento (recibirá gabapentin) Los pacientes recibirán una técnica anestésica habitual, basadas en drogas endovenosas mediante el método TCI (target controlled infusión). Con este método se unifica el uso de las drogas anestésicas, que son utilizadas de acuerdo a sexo, edad, género, peso y altura en cada uno de los pacientes. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Doctor

Model Details: Estudio Controlado, randomizado, prospectivo y ciego.

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: February 29, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)