Nerve BlocksNCT04036370
Continuous Pectoral Nerve Block in Breast Cancer Surgery
A study testing PECS group in people with Nerve Blocks and Breast Surgery, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Nerve Blocks, Breast Surgery, Postoperative Pain
- What is being tested?
- PECS group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2019to 15 Nov 2019
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) I-II
- 18-65 years
- Body mass index (BMI) ≤40 kg/m2
- Elective breast cancer surgery
Who cannot join
- ASA ≥4
- under 18 years of age or over 65 years of age
- declining to give written informed consent
- history of allergy to the local anesthetics
- contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc)
- history of breast surgery
Show all 9Show fewer
- treatment due to psychiatric disorder
- history of treatment for chronic pain
- history of nerve blocks in order to treat postoperative pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: The Effect of Continuous Pectoral Nerve Block on Postoperative Analgesia Consumption in Breast Cancer Surgery
The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.
Read the detailed description
Pectoral nerve block has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia in breast cancer surgery.
- Conditions
- Nerve Blocks, Breast Surgery, Postoperative Pain
- Being tested
- PECS group, Control group
- Keywords
- pectoral nerve block (pecs block), breast cancer, postoperative pain, numeric rating scale score (NRS score)
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS groupProcedure or surgery
Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.
Control groupOther
Standard pain follow up and monitorization will be performed.
| Study group | Role | What they receive |
|---|---|---|
| PECS group | Active comparator | In addition to routine analgesic protocol; before anaesthesia induction; following the PECS I + II block, a continuous infusion catheter will be placed at the PECS II block level under the guidance of USG, and local anesthetic infusion will be started via the catheter at the end of the operation. Receives: Procedure: PECS group |
| Control group | Sham comparator | Peroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block). Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia consumption
postoperative 12 hours
Measured: 12 hours
Secondary outcomes (2)
analgesia consumption
intraoperative
Measured: during the surgery
postoperative Numeric Rating Scale (NRS) score
postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12 hours
Measured: 0, 1, 3, 6, 9, 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start30 Jul 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nerve BlocksStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Arzu Karaveli, Antalya Training and Research Hospital
- Investigators
- Arzu Karaveli, Principal investigator, Antalya TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036370
- Sponsor's protocol ID
- 13/21
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
PubMed 22939099Blanco R, Parras Maldonado T. Reply to the article entitled "Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery". Reply of the authors. Rev Esp Anestesiol Reanim. 2013 May;60(5):296-7. doi: 10.1016/j.redar.2013.01.002. Epub 2013 Feb 27. No abstract available.
PubMed 23453236Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
PubMed 25376971
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Pectoral Nerve Block on Postoperative Analgesia Consumption in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT04036370
- Acronym / sponsor ID
- 13/21
- Conditions
- Nerve Blocks, Breast Surgery, Postoperative Pain
- Keywords
- pectoral nerve block (pecs block), breast cancer, postoperative pain, numeric rating scale score (NRS score)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 29 Jul 2019 (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.
The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.
Detailed description
Pectoral nerve block has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia in breast cancer surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised Controlled
| Arm | Type | Receives |
|---|---|---|
| PECS group | Active comparator | Procedure: PECS groupIn addition to routine analgesic protocol; before anaesthesia induction; following the PECS I + II block, a continuous infusion catheter will be placed at the PECS II block level under the guidance of USG, and local anesthetic infusion will be started via the catheter at the end of the operation. |
| Control group | Sham comparator | Other: Control groupPeroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology (ASA) I-II
- 18-65 years
- Body mass index (BMI) ≤40 kg/m2
- Elective breast cancer surgery
Key exclusion criteria (9 listed)
- ASA ≥4
- under 18 years of age or over 65 years of age
- declining to give written informed consent
- history of allergy to the local anesthetics
- contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc)
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 |
|---|---|---|
| PECS groupPecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed. | Procedure or surgery | PECS group |
| Control groupStandard pain follow up and monitorization will be performed. | Other | Control group |
Primary outcome
analgesia consumption
Time frame: 12 hours
postoperative 12 hours
2 secondary outcomes
analgesia consumption
Time frame: during the surgery
postoperative Numeric Rating Scale (NRS) score
Time frame: 0, 1, 3, 6, 9, 12 hours
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 18 Nov 2019.
- Background: PubMed 22939099Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
- Background: PubMed 23453236Blanco R, Parras Maldonado T. Reply to the article entitled "Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery". Reply of the authors. Rev Esp Anestesiol Reanim. 2013 May;60(5):296-7. doi: 10.1016/j.redar.2013.01.002. Epub 2013 Feb 27. No abstract available.
- Background: PubMed 25376971Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
- 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.
Arzu Karaveli principal investigator
Antalya TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PECS group in people with Nerve Blocks and Breast Surgery, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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 9 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 18 Nov 2019. 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 Turkey (Türkiye). 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.
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?
analgesia consumption (time frame: 12 hours). 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 NCT04036370, which also lists 3 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 18 Nov 2019.