Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial

Study Overview
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Brief Summary
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Study hypothesis: Combination of antioxidants and pregabalin results in better pain relief than placebo in patients with chronic pancreatitis. Chronic pancreatitis (CP) is a clinical enigma, with pain being the most distressing symptom that brings the patient to clinical attention. Pain in chronic pancreatitis is multifactorial, and may be related to pancreatic ductal hypertension, tissue hypertension, inflammatory cytokines, oxidative stress and neuropathic mechanisms like mechanical allodynia, inflammatory hyperalgesia and temporal summation. The mainstay of treatment for pain in CP due to pancreatic ductal stone is endotherapy (ESWL and ERCP). Recent randomized controlled trials have shown that antioxidant cocktail and pregabalin (a presynaptic voltage gated calcium channel blocking agent) can result in significant reduction of pain in CP. In this study, the investigators will study the efficacy of the combination of antioxidants and pregabalin in reducing pain and compare that with placebo. The investigators will randomize patients with documented chronic pancreatitis with recurrent/persistent pain after undergoing endotherapy and ductal clearance into three groups: Group A- antioxidants + pregabalin; Group B- Placebo. The primary outcome will be change in pain score and the secondary outcomes will be change in the number of painful days, analgesic requirements, quality of life and depression scale. Pain score will be quantified by the Izbicki pain score and visual analog scale; while quality of life and depression will be measured by the EORTC QLQ-C30/PAN26 and Beck depression inventory respectively. Comparison between Group A vs B will be made by the Chi square test/Fischer Exact and the Student's 't' tests respectively and analysis will be done on a intention to treat and per protocol basis. With an expected improvement of pain by 40% (at 80% power and alpha of 0.05) and adjusting for a presumed 10% drop out rate, the required sample size in each group will be at least 40.

Official Title
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Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Drug: Placebo
* Drug: Antioxidant plus Pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epigastric pain +/- radiation at least thrice in one month over the past three month. Endotherapy/Surgery and ducal clearance Exclusion Criteria: Age <18 and >65yrs MPD and biliary obstruction Pancreatic neoplastic lesions Acute flare Pancreatic pseudocysts Pregnancy Cardiac and renal diseases Use of other anti epileptics Hypersensitivity to gabapentin/pregabalin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>This group will contain a placebo for antioxidant cocktail and pregabalin | Drug: Placebo<br>* This group will include placebo.<br>|
| Experimental: Antioxidant plus pregabalin<br>This group will contain antioxidant cocktail and pregabalin | Drug: Antioxidant plus Pregabalin<br>* This group will contain combination of antioxidant cocktail and pregabalin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the pain score | Pain score will be assessed by the Izbicki pain score, Visual analog scale and painDETECT tool for neuropathic pain. | Baseline and 8weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of painful days | The number of days of pain per week will be measured. | Baseline and 8weeks | 
| Change in analgesic requirement | The type (opiate/non-opiate), number and route of additional analgesic medicines that were required within the study period will be evaluated. | Baseline and 8weeks | 
| Change in quality of life | QOL will be evaluated with the EORTC QLQ-C30/PAN26 questionnaire | Baseline and 8weeks | 
| Change in depression scale | Depression will be assessed with the Beck's Depression Inventory. | Baseline and 8weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pancreatitis, pregabalin, antioxidant