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

NCT03672162 | Completed DMC

• 1 other identifier: GabaCele
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Adverse effects of Gabepentin and Celecoxib at 24 hours post operation

  During acute post operation peroid as 24 hours post operation

• First opioid rescue dose at 24 hours post operation

  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 )

  During acute post operation peroid as 24 hours post operation

• Subjective pain at the time of discharge: numeric analog pain scale

  Date of discharge ,not longer than 7 days after admit

• Length of hospitalization stay

  Date from of admit to date of discharge,not longer than 7 days after admit

Study Arms (3)

Gabapentin Group

ACTIVE COMPARATOR

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

Celecoxib Group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Total abdominal hysterectomy PROCEDURE

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

Celecoxib Group; Gabapentin Group; Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 14, 2018
• Study Start: February 1, 2019
• Primary Completion: February 1, 2019
• Study Completion: September 30, 2019
• Last Updated: October 19, 2020

Record last verified: 2018-08

Locations

TH (1)