Post-operative PainNCT03796403
Bupivacaine Plus Diclofenac Versus Bupivacaine Alone for Postoperative Pain Relief in Gynecologic Cancer Patients
A study testing Diclofenac in people with Post-operative Pain, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS). Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- 15 Feb 2019to 30 Dec 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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy
- who has scheduled for operation via laparotomy route
- Women who has ASA physical status I-II
- All of the have age more than 20 years old
- able to communicate in Thai
- Women who agrees to participate in this study
Who cannot join
- patient who had emergency conditions - indication for emergency operation
- intraoperative cardiac arrhythmia
- operation purpose for only tumor biopsy
- Women who have abnormal kidney function test (Cr > 1.5)
- Women with history of gastrointestinal bleeding
- Women who take the antiplatelet or anticoagulant medications
- Women with history of allergy to bupivacaine and NSAIDs
- Women who cannot evaluated pain score
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bupivacaine Peritoneal Infiltration and Intramuscular Diclofenac Versus Bupivacaine Peritoneal Infiltration Alone for Postoperative Pain Relief in Gynecologic Cancer Patients Undergoing Open Surgery
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).
Read the detailed description
The primary objective is to compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective is to evaluate the time to first dose and the total amount of morphine requirement after the operation in both groups.
- Conditions
- Post-operative Pain
- Being tested
- Diclofenac
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacOther
Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
| Study group | Role | What they receive |
|---|---|---|
| diclofenac and bupivacaine group | Experimental | Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. Receives: Other: Diclofenac |
| bupivacaine only group | Placebo comparator | Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure. Receives: Other: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain relief
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). 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 (1)
Morphine requirement
evaluate the time to first dose post operation and the total amount of morphine requirement after the operation in both groups. Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.
Measured: During acute post operation period as 24 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start15 Feb 2019
- Primary completion30 Sep 2019
- Study completion30 Dec 2019
Why it stopped: Diclofenac is no longer recommend for intramuscular administration by the Medical Council of Thailand
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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
- Model description
- randomized into two groups by simple random. In bupivacaine and diclofenac group (n=70), Twenty ml of bupivacaine was infiltrated into surgical-site peritoneum and diclofenac 75 mg was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. In the bupivacaine alone group (n=70), 20 ml of bupivacaine was infiltrated into surgical-site peritoneum before closure and a 3 ml of sterile water was intramuscularly injected immediately after complete the procedure. Intravenous morphine injection was given if the pain score was more than 6 in the first 24 hours. Post-operation; time to first request of pain medication, doses, side effects, and vital signs were recorded. VAS was recorded at 2, 6, 12 and 24 hours post-operation and patients' satisfied score was recorded after 24 hours post-operation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Suphet Tuipae, MD, Principal investigator, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796403
- Sponsor's protocol ID
- Suphetgyn2516
- Status last verified
- Jan 2019
- First submitted
- 28 Sep 2018
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bupivacaine Peritoneal Infiltration and Intramuscular Diclofenac Versus Bupivacaine Peritoneal Infiltration Alone for Postoperative Pain Relief in Gynecologic Cancer Patients Undergoing Open Surgery
- ClinicalTrials.gov ID
- NCT03796403
- Acronym / sponsor ID
- Suphetgyn2516
- Conditions
- Post-operative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Diclofenac is no longer recommend for intramuscular administration by the Medical Council of Thailand
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 8 Jan 2019 (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.
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).
Detailed description
The primary objective is to compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective is to evaluate the time to first dose and the total amount of morphine requirement after the operation in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized into two groups by simple random. In bupivacaine and diclofenac group (n=70), Twenty ml of bupivacaine was infiltrated into surgical-site peritoneum and diclofenac 75 mg was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. In the bupivacaine alone group (n=70), 20 ml of bupivacaine was infiltrated into surgical-site peritoneum before closure and a 3 ml of sterile water was intramuscularly injected immediately after complete the procedure. Intravenous morphine injection was given if the pain score was more than 6 in the first 24 hours. Post-operation; time to first request of pain medication, doses, side effects, and vital signs were recorded. VAS was recorded at 2, 6, 12 and 24 hours post-operation and patients' satisfied score was recorded after 24 hours post-operation.
| Arm | Type | Receives |
|---|---|---|
| diclofenac and bupivacaine group | Experimental | Other: DiclofenacTwenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. |
| bupivacaine only group | Placebo comparator | Other: DiclofenacTwenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy
- who has scheduled for operation via laparotomy route
- Women who has ASA physical status I-II
- All of the have age more than 20 years old
- able to communicate in Thai
Key exclusion criteria (8 listed)
- patient who had emergency conditions - indication for emergency operation
- intraoperative cardiac arrhythmia
- operation purpose for only tumor biopsy
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 |
|---|---|---|
| DiclofenacTwenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing. | Other | bupivacaine only group, diclofenac and bupivacaine group |
Primary outcome
Post-operative pain relief
Time frame: During acute post operation peroid as 24 hours post operation
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.
1 secondary outcome
Morphine requirement
Time frame: During acute post operation period as 24 hours post operation
Results and safety
The study was stopped early (reason given: Diclofenac is no longer recommend for intramuscular administration by the Medical Council of Thailand). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Suphet Tuipae, MD principal investigator
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac in people with Post-operative Pain, 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 23 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 was stopped early (reason given: Diclofenac is no longer recommend for intramuscular administration by the Medical Council of Thailand). Results are not available in the source record.
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?
Post-operative pain relief (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 23 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.