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

Rajavithi Hospital

Status: Completed

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

Treatments: Procedure: Total abdominal hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03672162

GabaCele

Details and patient eligibility

About

Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial

Full 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

Enrollment: 90 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Gabapentin Group

Active Comparator group

Description:

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

Treatment:

Procedure: Total abdominal hysterectomy

Celecoxib Group

Active Comparator group

Description:

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

Treatment:

Procedure: Total abdominal hysterectomy

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Procedure: Total abdominal hysterectomy