Chronic Pancreatitis
Conditions
Keywords
chronic pancreatitis, pregabalin, antioxidant
Brief summary
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.
Interventions
DRUGPlacebo
This group will include placebo.
DRUGAntioxidant plus Pregabalin
This group will contain combination of antioxidant cocktail and pregabalin
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Epigastric pain +/- radiation at least thrice in one month over the past three month. 2. Endotherapy/Surgery and ducal clearance
Exclusion criteria
1. Age \<18 and \>65yrs 2. MPD and biliary obstruction 3. Pancreatic neoplastic lesions 4. Acute flare 5. Pancreatic pseudocysts 6. Pregnancy 7. Cardiac and renal diseases 8. Use of other anti epileptics 9. Hypersensitivity to gabapentin/pregabalin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the pain score | Baseline and 8weeks | Pain score will be assessed by the Izbicki pain score, Visual analog scale and painDETECT tool for neuropathic pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of painful days | Baseline and 8weeks | The number of days of pain per week will be measured. |
| Change in analgesic requirement | Baseline and 8weeks | The type (opiate/non-opiate), number and route of additional analgesic medicines that were required within the study period will be evaluated. |
| Change in quality of life | Baseline and 8weeks | QOL will be evaluated with the EORTC QLQ-C30/PAN26 questionnaire |
| Change in depression scale | Baseline and 8weeks | Depression will be assessed with the Beck's Depression Inventory. |
Countries
India
Outcome results
None listed