Back to resultsPreoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy
Primary Purpose
Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Total abdominal hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
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
Sites / Locations
- Rajavithi hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Gabapentin Group
Celecoxib Group
Placebo group
Arm 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
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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 .
First opioid rescue dose at 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 )
Total dose of opioid consumtion in 24 hours after surgery
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 .
Length of hospitalization stay
measure days of hospitalization since date of admit to date of discharge in this visitting
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03672162
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin Group
Arm Type
Active Comparator
Arm 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
Arm Title
Celecoxib Group
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Total abdominal hysterectomy
Intervention Description
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Primary Outcome Measure Information:
Title
Subjective pain at 24 hours post operation: numeric analog scale
Description
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 Outcome Measure Information:
Title
Adverse effects of Gabepentin and Celecoxib at 24 hours post operation
Description
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
Title
First opioid rescue dose at 24 hours post operation
Description
First time of reciving the opioid after surgery in 24 hours
Time Frame
During acute post operation peroid as 24 hours post operation
Title
Opioid consumption at 24 hours post operation (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery )
Description
Total dose of opioid consumtion in 24 hours after surgery
Time Frame
During acute post operation peroid as 24 hours post operation
Title
Subjective pain at the time of discharge: numeric analog pain scale
Description
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
Title
Length of hospitalization stay
Description
measure days of hospitalization since date of admit to date of discharge in this visitting
Time Frame
Date from of admit to date of discharge,not longer than 7 days after admit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Rajavithi hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Preoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy
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