Reviewed by Michael Gill, B. Sc.
Image of Department of Obstetrics and Gynecology, Mount Sinai Hospital in Toronto, Canada.
Phase-Based Progress Estimates
2
Effectiveness
3
Safety

Gabapentinfor Pelvic Organ Prolapse

18+
Female
Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed. Opioids are the first choice for pain medication administered after surgery, but carry significant side effects. Several studies have demonstrated that if patients are given gabapentin before surgery, they require less opioids after surgery. However, there have not been any studies examining gabapentin's effects on post-operative pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence. Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore patients experience a "bulge" or "pressure" in the vagina. Patients with these conditions are typically offered medical treatments, but some may require surgery, and this usually consists of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to patients undergoing urogynecologic surgery on their pain levels after surgery, including the amount of opioid pain medication required. We hypothesize that the patients who receive gabapentin before surgery will require significantly less opioids. Over a six-month period, patients seen in Urogynecology clinics will be invited to participate in the study. Women who are already on gabapentin for other reasons, have an allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand spoken English will be excluded from the study. After providing informed consent, they will be randomized to either receive gabapentin or a placebo pill. They will receive the standard surgical care, including the usual anesthesia for surgery and routine pain medications available after surgery. We will then compare the differences in opioid consumption in the first 24 hours after surgery as well as the time from the end of surgery to leaving to the recovery room and the length of recovery room stay between the gabapentin and placebo groups. We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the patients in each group.
Phase 3
Waitlist Available
Department of Obstetrics and Gynecology, Mount Sinai HospitalDanny Lovatsis, MD
25 Gabapentin Clinical Trials Near Me
Top Cities for Gabapentin Clinical Trials
Image of Boston in Massachusetts.
Boston
4Active Trials
Department of Oral and Maxillofacial Surgery, Massachusetts General HospitalTop Active Site
Most Recent Gabapentin Clinical Trials

What Are Gabapentin Clinical Trials?

Gabapentin clinical trials are research studies that test the safety and effectiveness of a new medication or treatment. Gabapentin is a medication commonly used to treat seizures and nerve pain.

However, clinical trials can be studied to see if Gabapentin can be applied to treat other conditions such as anxiety disorders, Depression, and Migraines. Also, Bipolar disorder and chronic pain conditions such as fibromyalgia.

Why Is Gabapentin Being Studied in Clinical Trials?

Gabapentin is being studied in clinical trials for its possible uses in a variety of conditions and illnesses, including:

  • Migraines
  • Pain relief
  • Seizures
  • Depression
  • Anxiety disorders
  • Restless legs syndrome (RLS)

Gabapentin is already approved by the U.S. Food and Drug Administration (FDA) for treating seizures and pain relief. However, researchers are still studying Gabapentin in clinical trials to see if it is effective for other conditions.

It's generally prescribed for seizure disorders such as epilepsy. Gabapentin is also approved to treat nerve-related pain, such as the pain that sometimes follows shingles. However, further testing is needed to see if Gabapentin is effective for other conditions such as migraines, bipolar disorder, and chronic pain.

How Does Gabapentin Work?

Gabapentin works by binding to a specific site on voltage-gated calcium channels found in nerve cells. This action decreases the release of neurotransmitters from these cells, such as glutamate and the substance P.

Gabapentin has also been shown to bind to the α2δ subunit of voltage-gated calcium channels. This binding may be responsible for Gabapentin's analgesic effects. Gabapentin may help relieve pain by affecting how the body senses pain.

Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter in the brain. However, more research needs to be tested to see how Gabapentin works in the brain to treat conditions such as seizures, pain relief, migraines, anxiety disorders, and depression.

What Are Some of The Breakthrough Clinical Trials Involving Gabapentin?

Gabapentin has shown promise in several clinical trials for various conditions. However, significant breakthroughs include the following studies:

2001: Gabapentin has also been studied as a treatment for migraine headaches. In one study, Gabapentin was found to be as effective as amitriptyline (a tricyclic antidepressant) in reducing the frequency of migraine headaches.

2002: Gabapentin has also been studied as a treatment for RLS. In one clinical trial, Gabapentin was shown to be more effective than a placebo in reducing the severity of RLS symptoms.

2004: For example, Gabapentin has been studied as a possible treatment for hot flashes in menopausal women. In one study, Gabapentin was shown to be more effective than a placebo in reducing the frequency and severity of hot flashes.

Who Are The Key Opinion Leaders On Gabapentin Clinical Trial Research?

Dr. Andrew Wilner. He has researched Gabapentin as a treatment for migraines, RLS, and other conditions. He is a board-certified internist, neurologist, and epilepsy specialist. He is also an Associate Professor of Neurology at the University of Tennessee Health Science Center in Memphis, TN.

Dr. Scott Fishman. He is the current vice president of the Department of Anesthesiology and Pain Medicine. He is also the Director of the Center for Advancing Pain Relief and a Professor at UC Davis. His research focuses on chronic pain, cancer management, and neuropathic pain treatment strategies.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 25th, 2021

Last Reviewed: October 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References1 Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. https://pubmed.ncbi.nlm.nih.gov/27487712 Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993 Jun;88(6):791-804. https://pubmed.ncbi.nlm.nih.gov/83299703 Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. https://pubmed.ncbi.nlm.nih.gov/4447884 Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. https://pubmed.ncbi.nlm.nih.gov/51464915 Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952. Review. https://pubmed.ncbi.nlm.nih.gov/280973056 Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. https://pubmed.ncbi.nlm.nih.gov/89919727 Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. https://pubmed.ncbi.nlm.nih.gov/25978118 Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. https://pubmed.ncbi.nlm.nih.gov/7286929 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. Review. https://pubmed.ncbi.nlm.nih.gov/1751365610 Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6. https://pubmed.ncbi.nlm.nih.gov/32253535