Mastectomy, Modified RadicalPhase 4NCT02551133
Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain
A Phase 4 study testing dexamethasone in people with Mastectomy, Modified Radical, run by Mustafa Kemal University.
Trial summary
This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half will receive 0.2 mg/kg dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Mastectomy, Modified Radical
- What is being tested?
- dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2015
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old, female patients
- Written informed consent.
Who cannot join
- American Society of Anesthesiologists Physical Status ˂3
- Any contraindication to dexamethasone
- Emergency or urgent procedure
- Obesity body mass index ≥27 kg m2
- Motion sickness and vertigo patients
- Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- Significant hepatic (Alanine aminotransferase or Aspartate aminotrans > 2 times normal)
- Renal (serum creatinine > 2 mg/dl) impairment
About this study
Official title: Comparison of the Two Different Doses of Dexamethasone on Persistent Mastectomy Pain
This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half will receive 0.2 mg/kg dexamethasone.
Read the detailed description
Breast cancer is the most frequent malignancy of middle age women (%32) and causes 19% of cancer-related deaths. Acute pain can contribute to the development of persistent surgical pain. Persistent postsurgical pain has been demonstrated to be clinically relevant in 10% to 50% of patients undergoing various common operations, including breast cancer surgery. The pathogenic mechanisms are multiple, including nerve damage related to surgical technique resulting in risk of intercostobrachial neuralgia, neuroma pain, or phantom breast pain. Multimodal analgesic strategies are important.Glucocorticoid steroids can also provide beneficial effects when administered in appropriate doses as part of a multimodal analgesic regimen in the perioperative setting. A recent study demonstrated that preoperative application of dexamethasone reduced postoperative nausea and vomiting and pain in patients after thyroidectomy.. It is possible that the already established reduction in prostaglandin synthesis mediated by dexamethasone contributes to the analgesia. And also there are a lot of mechanisms more.
- Conditions
- Mastectomy, Modified Radical
- Being tested
- dexamethasone
- Keywords
- Dexamethasone, mastectomy, persistent surgical pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
1 hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| 0.1 mg/kg dexamethasone | Active comparator | 0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery. Receives: Drug: dexamethasone |
| 0.2 mg/kg dexamethasone | Active comparator | 0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery. Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).
At 3.month persistent surgical pain will be evaluated using (visual analogue scale=VAS) (score ranges from O (no pain) to 10 (worst possible pain) . The difference between these VAS scores will be evaluated statistically.
Measured: Postoperative 3 months
Secondary outcomes (1)
Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).
0.h, 1.h, 2.h, 4.h, 8.h, 12.h, 24.h (visual analogue scale=VAS) (score ranges from O (no pain) to 10 (worst possible pain) postoperative pain will be evaluated in the acute 24 h postoperative period
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mastectomy, Modified RadicalStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Koyuncu, Mustafa Kemal University
- Investigators
- Onur Koyuncu, Assist.Prof, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551133
- Sponsor's protocol ID
- 208
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
PubMed 19092351Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.
PubMed 18682712
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Two Different Doses of Dexamethasone on Persistent Mastectomy Pain
- ClinicalTrials.gov ID
- NCT02551133
- Acronym / sponsor ID
- 208
- Conditions
- Mastectomy, Modified Radical
- Keywords
- Dexamethasone, mastectomy, persistent surgical pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- First posted
- 16 Sep 2015 (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.
This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half will receive 0.2 mg/kg dexamethasone.
Detailed description
Breast cancer is the most frequent malignancy of middle age women (%32) and causes 19% of cancer-related deaths. Acute pain can contribute to the development of persistent surgical pain. Persistent postsurgical pain has been demonstrated to be clinically relevant in 10% to 50% of patients undergoing various common operations, including breast cancer surgery. The pathogenic mechanisms are multiple, including nerve damage related to surgical technique resulting in risk of intercostobrachial neuralgia, neuroma pain, or phantom breast pain. Multimodal analgesic strategies are important.Glucocorticoid steroids can also provide beneficial effects when administered in appropriate doses as part of a multimodal analgesic regimen in the perioperative setting. A recent study demonstrated that preoperative application of dexamethasone reduced postoperative nausea and vomiting and pain in patients after thyroidectomy.. It is possible that the already established reduction in prostaglandin synthesis mediated by dexamethasone contributes to the analgesia. And also there are a lot of mechanisms more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1 mg/kg dexamethasone | Active comparator | Drug: dexamethasone0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery. |
| 0.2 mg/kg dexamethasone | Active comparator | Drug: dexamethasone0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 years old, female patients
- Written informed consent.
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists Physical Status ˂3
- Any contraindication to dexamethasone
- Emergency or urgent procedure
- Obesity body mass index ≥27 kg m2
- Motion sickness and vertigo patients
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 |
|---|---|---|
| dexamethasone1 hour before surgery | Drug | 0.1 mg/kg dexamethasone, 0.2 mg/kg dexamethasone |
Primary outcome
Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).
Time frame: Postoperative 3 months
At 3.month persistent surgical pain will be evaluated using (visual analogue scale=VAS) (score ranges from O (no pain) to 10 (worst possible pain) . The difference between these VAS scores will be evaluated statistically.
1 secondary outcome
Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).
Time frame: Postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- Background: PubMed 19092351Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
- Background: PubMed 18682712Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.
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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.
Onur Koyuncu, Assist.Prof principal investigator
Mustafa Kemal University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone in people with Mastectomy, Modified Radical, run by Mustafa Kemal University.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2015. 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. 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?
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?
Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS). (time frame: Postoperative 3 months). 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 NCT02551133, which also lists 2 linked publications.
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 16 Sep 2015.