Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , CelecoxibNCT03672162
Preoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy
A study testing Total abdominal hysterectomy in people with Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
- What is being tested?
- Total abdominal hysterectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Total abdominal hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total abdominal hysterectomyProcedure or surgery
Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Total abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During acute post operation peroid as 24 hours post operation
Secondary outcomes (5)
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 .
Measured: 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
Measured: 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
Measured: 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 .
Measured: 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
Measured: Date from of admit to date of discharge,not longer than 7 days after admit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Feb 2019
- Primary completion1 Feb 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , CelecoxibStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672162
- Sponsor's protocol ID
- GabaCele
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Preoperative Gabapentin With Celecoxib in Reducing Acute Postoperative Pain in Abdominal Hysterectomy, A Randomized Double Blindcontrolled Trial
- ClinicalTrials.gov ID
- NCT03672162
- Acronym / sponsor ID
- GabaCele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gabapentin Group | Active comparator | Procedure: Total abdominal hysterectomySubjects 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 |
| Celecoxib Group | Active comparator | Procedure: Total abdominal hysterectomySubjects 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 |
| Placebo group | Placebo comparator | Procedure: Total abdominal hysterectomySubjects will receive Placebo (two capsules of placebo) at two hours prior to surgery with clear water 30 ml and undergo elective total abdominal hysterectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total abdominal hysterectomyEach drug group undergo elective total abdominal hysterectomy with the same general anesthesia | Procedure or surgery | Celecoxib Group, Gabapentin Group, Placebo group |
Primary outcome
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
5 secondary outcomes
Adverse effects of Gabepentin and Celecoxib at 24 hours post operation
Time frame: During acute post operation peroid as 24 hours post operation
First opioid rescue dose at 24 hours post operation
Time frame: 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 )
Time frame: During acute post operation peroid as 24 hours post operation
Subjective pain at the time of discharge: numeric analog pain scale
Time frame: Date of discharge ,not longer than 7 days after admit
Length of hospitalization stay
Time frame: Date from of admit to date of discharge,not longer than 7 days after admit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total abdominal hysterectomy in people with Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective pain at 24 hours post operation: numeric analog scale (time frame: During acute post operation peroid as 24 hours post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.