Preoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy

Department of Medical Services Ministry of Public Health of Thailand90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib

Interventions

Total abdominal hysterectomyPROCEDURE

Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rajavithi hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

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

Time frame: During acute post operation peroid as 24 hours post operation

Secondary Outcomes

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 .

Time frame: 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

Time frame: 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

Time frame: 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 .

Time frame: Date of discharge ,not longer than 7 days after admit

Length of hospitalization stay

Data from ClinicalTrials.gov

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