Gastrointestinal RecoveryNCT04314310
Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia
A study testing Tenoxicam in people with Gastrointestinal Recovery, run by National Taiwan University Hospital.
Trial summary
breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Gastrointestinal Recovery
- What is being tested?
- Tenoxicam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2020to 31 Dec 2025
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I to II Breast cancer patients Mastectomy or wide local excision + axillary note dissection
Who cannot join
- Preexisting malignancy Chronic infection Previous pain condition Diabetes Thyroid disorder Severe cardiac, renal or hepatic disease Previous breast surgery Psychiatric illness Neurological disease Contraindication for tenoxicam or morphine use
Trial locations and contacts
No sites are listed yet.
Ya-Jung Cheng, MD,PhD contact
About this study
Official title: Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia in Patients Receiving Abdominal and Non-abdominal Surgeries.
breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer.
Read the detailed description
thrity patients participated in this randomized, single-blined study. Before and at the postoperative day 1, the bowel function (orocecal transmit time) were measured. Before induction of general anesthesia, patients recieved a bolus of intravenous Tenoxicam or an equal volume of saline (control group). Pain score and opioid consumption were recorded in the postoperative period and then daily for 1 week.
- Conditions
- Gastrointestinal Recovery
- Being tested
- Tenoxicam, Placebo
- Keywords
- orocecal transmit time, flatus
- Medical subject headings
- Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenoxicamDrug
nonsteroidal anti-inflammatory drug (NSAID)
PlaceboDrug
equal volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Tenoxicam | Active comparator | nonsteroidal anti-inflammatory drug (NSAID) Receives: Drug: Tenoxicam |
| placebo | Placebo comparator | equal volume of normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
morphine consumption after breast cancer surgery
Measured: until postoperative day7
Secondary outcomes (1)
orocecal transmit time,
smal intestinal function
Measured: preoperative and postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start23 Mar 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal RecoveryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- treatment: Tenoxicam; control: placebo
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314310
- Sponsor's protocol ID
- 201912245RINB
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical concern
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Recovery of Postoperative Gastrointestinal Function With Multimodal Analgesia in Patients Receiving Abdominal and Non-abdominal Surgeries.
- ClinicalTrials.gov ID
- NCT04314310
- Acronym / sponsor ID
- 201912245RINB
- Conditions
- Gastrointestinal Recovery
- Keywords
- orocecal transmit time, flatus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Mar 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Mar 2020 (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.
breast cancer surgery is associated with a high incidence of persistant postsurgical pain (PPSP). The aim of the study was to evluate the impact of intravenous Tenoxicam on acute and PPSP, analgesic requirements and gastrointestinal recovery in patients undergoing surgery for breast cancer.
Detailed description
thrity patients participated in this randomized, single-blined study. Before and at the postoperative day 1, the bowel function (orocecal transmit time) were measured. Before induction of general anesthesia, patients recieved a bolus of intravenous Tenoxicam or an equal volume of saline (control group). Pain score and opioid consumption were recorded in the postoperative period and then daily for 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- treatment: Tenoxicam; control: placebo
| Arm | Type | Receives |
|---|---|---|
| Tenoxicam | Active comparator | Drug: Tenoxicamnonsteroidal anti-inflammatory drug (NSAID) |
| placebo | Placebo comparator | Drug: Placeboequal volume of normal saline |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I to II Breast cancer patients Mastectomy or wide local excision + axillary note dissection
Key exclusion criteria (1 listed)
- Preexisting malignancy Chronic infection Previous pain condition Diabetes Thyroid disorder Severe cardiac, renal or hepatic disease Previous breast surgery Psychiatric illness Neurological disease Contraindication for tenoxicam or morphine use
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 |
|---|---|---|
| Tenoxicamnonsteroidal anti-inflammatory drug (NSAID) | Drug | Tenoxicam |
| Placeboequal volume of normal saline | Drug | placebo |
Primary outcome
morphine consumption
Time frame: until postoperative day7
morphine consumption after breast cancer surgery
1 secondary outcome
orocecal transmit time,
Time frame: preoperative and postoperative day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No. due to ethical concern
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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.
Ya-Jung Cheng, MD,PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Tenoxicam in people with Gastrointestinal Recovery, run by National Taiwan University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Jung Cheng, MD,PhD (chengyj@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: until postoperative day7). 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 Mar 2020.