Mammary CancerNCT03204708
Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy
A study testing catheter and iv analgesia in people with Mammary Cancer, run by Istanbul University.
Trial summary
patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Mammary Cancer
- What is being tested?
- catheter and iv analgesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 28 Feb 2017
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Americans Class I-II
Who cannot join
- male
- allergy to local anesthetics or
- anticoagulant drug use
- central or peripheric nerve disease
- pregnancy
About this study
Official title: Evaluation of the Postoperative Analgesic Efficacy of Catheter Placed Interpectoral Region Via Open Technique in Patients Undergoing Modified Radical Mastectomy
patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.
Read the detailed description
patients undergoing modified radical mastectomy were divided into two groups by computer. patients in catheter group were placed a catheter under clavipectoral fascia in the neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula. solution included 10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given via the catheter for postoperative analgesia at the end of surgery. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. Patients in both groups were given dexketoprofen 50 mg iv if the VAS score was over 4. VAS scores, rescue analgesic requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24 hours and 90 days after surgery.
- Conditions
- Mammary Cancer
- Being tested
- catheter, iv analgesia
- Keywords
- postoperative analgsia, peripheral block catheter, modified radical mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheterDevice
catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis
iv analgesiaDrug
patients were given 100 ml of tramadol 30 minutes before extubation
| Study group | Role | What they receive |
|---|---|---|
| iv analgesia | Active comparator | patients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy. Receives: Device: catheter; Drug: iv analgesia |
| catheter group | Active comparator | patients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia Receives: Device: catheter; Drug: iv analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scores
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
Measured: 1 hour after operation
VAS scores
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
Measured: 6 hours after operation
VAS scores
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
Measured: 12 hours after operation
VAS scores
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
Measured: 24 hours after operation
Secondary outcomes (1)
VAS scores
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
Measured: 3 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start15 Apr 2016
- Primary completion15 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammary CancerStudies of the same condition, open and under way.
- More trials run by Istanbul 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
- Investigators
- cigdem akyol beyoglu, MD, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204708
- Sponsor's protocol ID
- 88931902-604.01.01
- Status last verified
- Feb 2018
- First submitted
- 22 May 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Postoperative Analgesic Efficacy of Catheter Placed Interpectoral Region Via Open Technique in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT03204708
- Acronym / sponsor ID
- 88931902-604.01.01
- Conditions
- Mammary Cancer
- Keywords
- postoperative analgsia, peripheral block catheter, modified radical mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 2 Jul 2017 (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.
patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.
Detailed description
patients undergoing modified radical mastectomy were divided into two groups by computer. patients in catheter group were placed a catheter under clavipectoral fascia in the neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula. solution included 10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given via the catheter for postoperative analgesia at the end of surgery. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. Patients in both groups were given dexketoprofen 50 mg iv if the VAS score was over 4. VAS scores, rescue analgesic requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24 hours and 90 days after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iv analgesia | Active comparator | Device: catheter, Drug: iv analgesiapatients were given intravenously 100 mg of tramadol (contramal) 30 minutes before extubation after modified radical mastectomy. |
| catheter group | Active comparator | Device: catheter, Drug: iv analgesiapatients were placed a catheter under clavipectoral fascia and 30 ml of local anesthetic solution were given via catheter for postoperative analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Americans Class I-II
Key exclusion criteria (5 listed)
- male
- allergy to local anesthetics or
- anticoagulant drug use
- central or peripheric nerve disease
- pregnancy
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 |
|---|---|---|
| cathetercatheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis | Device | catheter group, iv analgesia |
| iv analgesiapatients were given 100 ml of tramadol 30 minutes before extubation | Drug | catheter group, iv analgesia |
Primary outcome
VAS scores
Time frame: 1 hour after operation
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
VAS scores
Time frame: 6 hours after operation
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
VAS scores
Time frame: 12 hours after operation
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
VAS scores
Time frame: 24 hours after operation
patients were asked to give a point between 0 to 10 for their pain level. 0 is no pain, 10 is the strongest pain.
1 secondary outcome
VAS scores
Time frame: 3 months after operation
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 13 Feb 2018.
- 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.
cigdem akyol beyoglu, MD study director
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing catheter and iv analgesia in people with Mammary Cancer, run by Istanbul 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 1 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 13 Feb 2018. 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.
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?
VAS scores (time frame: 1 hour after operation). The study lists 4 primary outcomes in all. 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 13 Feb 2018.