Postoperative PainPhase 4DTMPCANCT00564603
Continuous Infusion of Dexamethasone Plus Tramadol Adjunct to Morphine PCA After Abdominal Hysterectomy
A Phase 4 study testing Dexamethasone Sodium Phosphate Injection and 0.9% Saline in people with Postoperative Pain and Post Operative Analgesia, run by Nanjing Medical University at 1 site in China.
Trial summary
Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. Read more about this study
- Who is it for?
- Ages 19 to 64 years, women only
- Conditions the study is for
- Postoperative Pain, Post Operative Analgesia, Patient-Controlled Analgesia
- What is being tested?
- Dexamethasone Sodium Phosphate Injection and 0.9% Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2007to Nov 2007
- Phase
- Phase 4
- 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 19 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II
- Chinese
- 19-64yr
- Uterus myoma
Who cannot join
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
- Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
- Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
- Those who were not willing to or could not finish the whole study at any time.
- Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy
Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.
- Conditions
- Postoperative Pain, Post Operative Analgesia, Patient-Controlled Analgesia, Abdominal Surgeries
- Being tested
- Dexamethasone Sodium Phosphate Injection, 0.9% Saline
- Keywords
- Glucocorticoid, Opioids, Balanced analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium Phosphate InjectionDrug
Dexamethasone, 10mg, continuously infused up to 48h after surgeries.
0.9% SalineOther
Saline, in same volume of 2mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Saline with same volume added to tramadol infusion combined with morphine PCA. Receives: Other: 0.9% Saline |
| 2 | Active comparator | Dexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA. Receives: Drug: Dexamethasone Sodium Phosphate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) of pain
Measured: 0-48h after surgeries
Secondary outcomes (1)
First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
Measured: 0-48h after surgeries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564603
- Sponsor's protocol ID
- NMU-2579-5FW
- Other IDs
- 06NMUZ028
- Acronym
- DTMPCA
- Status last verified
- Apr 2008
- First submitted
- 26 Nov 2007
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT00564603
- Acronym / sponsor ID
- DTMPCA / NMU-2579-5FW
- Conditions
- Postoperative Pain, Post Operative Analgesia, Patient-Controlled Analgesia, Abdominal Surgeries
- Keywords
- Glucocorticoid, Opioids, Balanced analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Aug 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 28 Nov 2007 (estimated)
- 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.
Dexamethasone has been recognized as an antiemetic agent after surgeries, and the combination of dexamethasone and tramadol remained stable in solution up to 5 days. In addition, i.v. basal infusion of tramadol is a certified technique in postoperative pain management. We purposed that combined administration of dexamethasone and tramadol adjunct to i.v. morphine is an effective way in treating postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: 0.9% SalineSaline with same volume added to tramadol infusion combined with morphine PCA. |
| 2 | Active comparator | Drug: Dexamethasone Sodium Phosphate InjectionDexamethasone 10mg in 2mL added to tramadol infusion adjunct to morphine PCA. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I-II
- Chinese
- 19-64yr
- Uterus myoma
Key exclusion criteria (5 listed)
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records.
- Participants younger than 18yr，older than 65yr or pregnancy was eliminated.
- Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study.
- Those who were not willing to or could not finish the whole study at any time.
- Any patient who exhibited a combative or incoherent state of PCA analgesia would be excluded from the study.
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 |
|---|---|---|
| Dexamethasone Sodium Phosphate InjectionDexamethasone, 10mg, continuously infused up to 48h after surgeries. | Drug | 2 |
| 0.9% SalineSaline, in same volume of 2mL | Other | 1 |
Primary outcome
Visual analog scale (VAS) of pain
Time frame: 0-48h after surgeries
1 secondary outcome
First requirement of morphine; Total morphine consumption; VAS sedation; VAS satisfaction; Side effects; Overall conditions of patients;
Time frame: 0-48h after surgeries
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 21 Apr 2008.
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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.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Sodium Phosphate Injection and 0.9% Saline in people with Postoperative Pain and Post Operative Analgesia, run by Nanjing Medical University at 1 site in China.
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 4 inclusion and 5 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 21 Apr 2008. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual analog scale (VAS) of pain (time frame: 0-48h after surgeries). 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 21 Apr 2008.