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

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

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

Study Overview

• Status: Completed
• Conditions: Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
• Intervention / Treatment: Procedure: Total abdominal hysterectomy

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gabapentin Group; 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	Procedure: Total abdominal hysterectomy; Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Active Comparator: Celecoxib Group; 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	Procedure: Total abdominal hysterectomy; Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Placebo Comparator: Placebo group; 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	Procedure: Total abdominal hysterectomy; Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: GabaCele

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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