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

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

Official title:

Comparison of Effectiveness of Preoperative Gabapentin With Celecoxib in Reducing Acute Postoperative Pain in Abdominal Hysterectomy, A Randomized Double Blindcontrolled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672162
• Other study ID #: GabaCele
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Total abdominal hysterectomy
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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 .	During acute post operation peroid as 24 hours post operation
Secondary	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
Secondary	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
Secondary	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
Secondary	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