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Completed

NCT Number: NCT03672162

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 blind controlled trial

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi hospital

Bangkok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total abdominal hysterectomy

Procedure

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

Primary outcomes

  1. Subjective pain at 24 hours post operation: numeric analog scale

    Time frame: During acute post operation peroid as 24 hours post operation

    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 outcomes

  1. Adverse effects of Gabepentin and Celecoxib at 24 hours post operation

    Time frame: During acute post operation peroid as 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 .

  2. First opioid rescue dose at 24 hours post operation

    Time frame: During acute post operation peroid as 24 hours post operation

    First time of reciving the opioid after surgery in 24 hours

  3. Opioid consumption at 24 hours post operation (at first visit at inpatient ward , 4,5,8,12 and 24 hours after surgery )

    Time frame: During acute post operation peroid as 24 hours post operation

    Total dose of opioid consumtion in 24 hours after surgery

  4. Subjective pain at the time of discharge: numeric analog pain scale

    Time frame: Date of discharge ,not longer than 7 days after admit

    Assessment of subjective pain score at the time of discharge ,will use a numeric analog scale from 0-10 .

  5. Length of hospitalization stay

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

    measure days of hospitalization since date of admit to date of discharge in this visitting

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.