Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
Conditions
Brief summary
Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial
Detailed description
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
Interventions
PROCEDURETotal abdominal hysterectomy
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Women ranging age between 18-65 years and having non-gynecological cancerous women who undergoing elective total abdominal hysterectomy * Women who has ASA physical status I-II * Women who agrees to participate in this study
Exclusion criteria
* Women who pregnancy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective pain at 24 hours post operation: numeric analog scale | During acute post operation peroid as 24 hours post operation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects of Gabepentin and Celecoxib at 24 hours post operation | During acute post operation peroid as 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 . |
| First opioid rescue dose at 24 hours post operation | During acute post operation peroid as 24 hours post operation | First time of reciving the opioid after surgery in 24 hours |
| Opioid consumption at 24 hours post operation (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery ) | During acute post operation peroid as 24 hours post operation | Total dose of opioid consumtion in 24 hours after surgery |
| Subjective pain at the time of discharge: numeric analog pain scale | Date of discharge ,not longer than 7 days after admit | Assessment of subjective pain score at the time of discharge ,will use a numeric analog scale from 0-10 . |
| Length of hospitalization stay | Date from of admit to date of discharge,not longer than 7 days after admit | measure days of hospitalization since date of admit to date of discharge in this visitting |
Countries
Thailand
Outcome results
None listed