Preoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy
NCT ID: NCT03672162
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2019-02-01
2019-09-30
Brief Summary
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Detailed Description
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ERAS guidelines has considered to use preoperative analgesics for reducing post-operative opioids consumption, including Gabapentin and Celecoxib.
Gabapentin and celecoxib widely used for treatment of pain and many studies have demonstrated the preoperative efficacy and safety of Gabapentin and Celecoxib in variety procedures involving hysterectomy.However, no definite conclusion of optimal dose and timing for preopearive uptake ,apart from no good evidences based supported preoperative Gabapentin or Celecoxib in hysterectomy in Thailand . In addition, the protocol for preoperative analgesics in hysterectomy, has not been performed in the investigator's center.
Therefore the aim of this study is to assess and compare the efficacy and safety of preoperative Gabapentin and Celecoxib to reduce acute postoperative pain in non-gynecological cancerous woman undergoing total abdominal hysterectomy
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Gabapentin Group
Subjects will receive Gabapentin 600 mg (two capsules of Gabapentin 300 mg) at two hours prior to surgery with clear water 30 ml and undergo elective total abdominal hysterectomy
Total abdominal hysterectomy
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Celecoxib Group
Subjects will receive Celecoxib 400 mg (two capsules of Celecoxib 200 mg) at two hours prior to surgery with clear water 30 ml and undergo elective total abdominal hysterectomy
Total abdominal hysterectomy
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Placebo group
Subjects will receive Placebo (two capsules of placebo) at two hours prior to surgery with clear water 30 ml and undergo elective total abdominal hysterectomy
Total abdominal hysterectomy
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Interventions
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Total abdominal hysterectomy
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Eligibility Criteria
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Inclusion Criteria
* Women who has ASA physical status I-II
* Women who agrees to participate in this study
Exclusion Criteria
* Women who have abnormal kidney function test (Cr \> 1.5 )
* Women who have abnormal liver function test
* Women with history or present of thrombosis such as myocardial infarction, ischemic stroke, deep venous thrombosis or pulmonic embolism
* Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding
* Women who take the antiplatelet or anticoagulant medications
* Women with history of allergy to Gabapentin ,Celecoxib and Sulfa
* Women who have used or known Gabapentin or Celecoxib before
* Women who have chronic alcoholism
* Women who underwent previous surgery
* Women who undergo extended low midline incision
* Women who undergo lysis adhesion
* Women who undergo further operations except salpingo-oophorectomy
* Women who cannot evaluated pain score
18 Years
65 Years
FEMALE
Yes
Sponsors
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Department of Medical Services Ministry of Public Health of Thailand
OTHER_GOV
Responsible Party
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Locations
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Rajavithi hospital
Bangkok, , Thailand
Countries
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Other Identifiers
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GabaCele
Identifier Type: -
Identifier Source: org_study_id
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