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Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial
Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide.Some studies noticed about overused of opioids in postoperative care , leaded to more adverse effect of opioids , slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin Group | Active Comparator | 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 |
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| Celecoxib Group | Active Comparator | 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 |
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| Placebo group | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total abdominal hysterectomy | Procedure | Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective pain at 24 hours post operation: numeric analog scale | Assessment of subjective pain score post operation at 24 hours (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery ),by using a numeric analog pain scale from .Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid | During acute post operation peroid as 24 hours post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects of Gabepentin and Celecoxib at 24 hours post operation | Will assess for known symptoms of Gabapentin post operation 24 hours (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery ).We will survey subjects regarding their experience of the following symptoms : nausea and vomiting ,dizziness, drowsiness ,allergic reaction ,chest pain ,and gastrointestinal bleeding . |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi hospital | Bangkok | 10400 | Thailand |
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| During acute post operation peroid as 24 hours post operation |
| First opioid rescue dose at 24 hours post operation | First time of reciving the opioid after surgery in 24 hours | During acute post operation peroid as 24 hours post operation |
| Opioid consumption at 24 hours post operation (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery ) | Total dose of opioid consumtion in 24 hours after surgery | During acute post operation peroid as 24 hours post operation |
| Subjective pain at the time of discharge: numeric analog pain scale | Assessment of subjective pain score at the time of discharge ,will use a numeric analog scale from 0-10 . | Date of discharge ,not longer than 7 days after admit |
| Length of hospitalization stay | measure days of hospitalization since date of admit to date of discharge in this visitting | Date from of admit to date of discharge,not longer than 7 days after admit |