Clinical trial NCT03672162: Preoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy
Official title: Comparison of Effectiveness of Preoperative Gabapentin With Celecoxib in Reducing Acute Postoperative Pain in Abdominal Hysterectomy, A Randomized Double Blindcontrolled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-09-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Subjective pain at 24 hours post operation: numeric analog scale
timeFrame: During acute post operation peroid as 24 hours post operation
Secondary outcomes:
measure: Adverse effects of Gabepentin and Celecoxib at 24 hours post operation
timeFrame: During acute post operation peroid as 24 hours post operation
measure: First opioid rescue dose at 24 hours post operation
timeFrame: During acute post operation peroid as 24 hours post operation
measure: Opioid consumption at 24 hours post operation (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery )
timeFrame: During acute post operation peroid as 24 hours post operation
measure: Subjective pain at the time of discharge: numeric analog pain scale
timeFrame: Date of discharge ,not longer than 7 days after admit
measure: Length of hospitalization stay
timeFrame: Date from of admit to date of discharge,not longer than 7 days after admit
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
References: