Pain, PostoperativePhase 4COPTEAMNCT00519246
Comparison of Pain Therapeutic Effects After Benign Mastectomy
A Phase 4 study testing Saline, Opioid and NSAID in people with Pain, Postoperative and Mastectomy, run by Nanjing Medical University at 1 site in China.
Trial summary
With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Pain, Postoperative, Mastectomy
- What is being tested?
- Saline, Opioid and NSAID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Feb 2007to Dec 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 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Chinese
- No cardiac and pulmonary diseases
- ASA I-II
- No alcohol drinking.
Who cannot join
- <19yrs, and >65yrs
- History of central active drugs administration
- Drug abuse
- Hypertension
- Diabetes
- Any other chronic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy
With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.
- Conditions
- Pain, Postoperative, Mastectomy
- Being tested
- Saline, Opioid, NSAID
- Keywords
- Breast Neoplasms, Non-Steroidal Anti-Inflammatory Agents, Analgesia
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called Physiological solution
Saline 5 ml administrated intravenously
OpioidDrug
Also called NuoYang
Butorphanol tartrate 1 mg i.v.
OpioidDrug
Also called NuoYang
Butorphanol Tartrate 2 mg i.v.
NSAIDDrug
Also called CaiFen
Flurbiprofen Axetil 50 mg i.v.
NSAIDDrug
Also called CaiFen
Flurbiprofen Axetil 100 mg i.v.
OpioidDrug
Also called Trama
Tramadol Hydrochloride 10 mg i.v.
OpioidDrug
Also called Trama
Tramadol Hydrochloride 20 mg i.v.
| Study group | Role | What they receive |
|---|---|---|
| I | Placebo comparator | No drug was delivered. Receives: Drug: Saline |
| II | Active comparator | Butorphanol tartrate 1mg was given intravenously. Receives: Drug: Opioid |
| III | Active comparator | Butorphanol tartrate 2 mg was given intravenously. Receives: Drug: Opioid |
| IV | Active comparator | Flurbiprofen Axetil 50 mg was given intravenously. Receives: Drug: NSAID |
| V | Active comparator | Flurbiprofen Axetil 100 mg was given intravenously. Receives: Drug: NSAID |
| VI | Active comparator | Tramadol Hydrochloride 10 mg was given intravenously. Receives: Drug: Opioid |
| VII | Active comparator | Tramadol Hydrochloride 20 mg was given intravenously. Receives: Drug: Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) rating of pain
Measured: 0-24h after surgeries
Secondary outcomes (3)
VAS rating of sedation
Measured: 0h to 24h after the end of the operation
Overall VAS rating of satisfaction with analgesia
Measured: 24 h after operation
Incidence of side effects
Measured: From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519246
- Sponsor's protocol ID
- NMU-2579-4FW
- Other IDs
- NMCH2007-241
- Acronym
- COPTEAM
- Status last verified
- Mar 2009
- First submitted
- 21 Aug 2007
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shen X, Wang F, Xu S, Ma L, Liu Y, Feng S, Wang W, Zhao Q, Li X, Zhao L, Yao X, Qu J, Xie B, Wang H, Yuan H, Cao Y, Sun Y, Wang W, Guo L, Song Z, Wang Z, Guan X. Comparison of the analgesic efficacy of preemptive and preventive tramadol after lumpectomy. Pharmacol Rep. 2008 May-Jun;60(3):415-21.
PubMed 18622068
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy
- ClinicalTrials.gov ID
- NCT00519246
- Acronym / sponsor ID
- COPTEAM / NMU-2579-4FW
- Conditions
- Pain, Postoperative, Mastectomy
- Keywords
- Breast Neoplasms, Non-Steroidal Anti-Inflammatory Agents, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Aug 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.
With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| I | Placebo comparator | Drug: SalineNo drug was delivered. |
| II | Active comparator | Drug: OpioidButorphanol tartrate 1mg was given intravenously. |
| III | Active comparator | Drug: OpioidButorphanol tartrate 2 mg was given intravenously. |
| IV | Active comparator | Drug: NSAIDFlurbiprofen Axetil 50 mg was given intravenously. |
| V | Active comparator | Drug: NSAIDFlurbiprofen Axetil 100 mg was given intravenously. |
| VI | Active comparator | Drug: OpioidTramadol Hydrochloride 10 mg was given intravenously. |
| VII | Active comparator | Drug: OpioidTramadol Hydrochloride 20 mg was given intravenously. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese
- No cardiac and pulmonary diseases
- ASA I-II
- No alcohol drinking.
Key exclusion criteria (6 listed)
- <19yrs, and >65yrs
- History of central active drugs administration
- Drug abuse
- Hypertension
- Diabetes
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 |
|---|---|---|
| SalineAlso: Physiological solutionSaline 5 ml administrated intravenously | Drug | I |
| OpioidAlso: NuoYangButorphanol tartrate 1 mg i.v. | Drug | II |
| OpioidAlso: NuoYangButorphanol Tartrate 2 mg i.v. | Drug | III |
| NSAIDAlso: CaiFenFlurbiprofen Axetil 50 mg i.v. | Drug | IV |
| NSAIDAlso: CaiFenFlurbiprofen Axetil 100 mg i.v. | Drug | V |
| OpioidAlso: TramaTramadol Hydrochloride 10 mg i.v. | Drug | VI |
| OpioidAlso: TramaTramadol Hydrochloride 20 mg i.v. | Drug | VII |
Primary outcome
Visual analog scale (VAS) rating of pain
Time frame: 0-24h after surgeries
3 secondary outcomes
VAS rating of sedation
Time frame: 0h to 24h after the end of the operation
Overall VAS rating of satisfaction with analgesia
Time frame: 24 h after operation
Incidence of side effects
Time frame: From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)
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 31 Mar 2009.
- Results publication: PubMed 18622068Shen X, Wang F, Xu S, Ma L, Liu Y, Feng S, Wang W, Zhao Q, Li X, Zhao L, Yao X, Qu J, Xie B, Wang H, Yuan H, Cao Y, Sun Y, Wang W, Guo L, Song Z, Wang Z, Guan X. Comparison of the analgesic efficacy of preemptive and preventive tramadol after lumpectomy. Pharmacol Rep. 2008 May-Jun;60(3):415-21.
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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 chair
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 Saline, Opioid and NSAID in people with Pain, Postoperative and Mastectomy, 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 6 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 31 Mar 2009. 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) rating of pain (time frame: 0-24h after surgeries). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00519246, which also lists 1 linked publication.
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 31 Mar 2009.