Nerve BlocksNCT03857386
Efficacy of Pectoral Nerve Block for Breast Reduction Surgery
An observational study of 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 efficacy of PECS block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia. 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
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 1 May 2018
- Phase
- Observational
- 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
Study population: The study included patients with ASA I-II, 18-65 years old, with a BMI ≤ 40 kg/m2 and undergoing elective breast reduction operation under general anesthesia.
Who may be able to join
- American Society of Anesthesiology (ASA) I-II
- body mass index (BMI) ≤40 kg/m2
- elective bilateral breast reduction surgery
Who cannot join
- declining to give written informed consent
- ASA III and above
- under 18 years of age or over 65 years of age
- history of allergy against to the local anesthetics,
- controendication 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 a 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: Comparison of The Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Analgesia for Breast Reduction Surgery
The purpose of the study is to evaluate the efficacy of PECS block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia.
Read the detailed description
Pectoral nerve block (PECS 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 especially in breast cancer surgery and subpectoral breast prosthesis.
- Conditions
- Nerve Blocks, Breast Surgery, Postoperative Pain
- Being tested
- PECS group, Control group
- Keywords
- pectoral nerve block (PECS block), breast reduction surgery, ultrasonography, postoperative pain, VAS score
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECS groupProcedure or surgery
Also called Regional anesthesia in breast surgery
Pecs block performed using ultrasound guidance
Control groupProcedure or surgery
Also called Regional anesthesia in breast surgery
Local infiltration anesthesia performed during the operation
| Study group | Role | What they receive |
|---|---|---|
| PECS group | Preoperative bilateral PECS I + PECS II Pecs block performed by anaesthetist using ultrasound guidance in plane approach Receives: Procedure: PECS group | |
| Control group | Bilateral local anesthesia infiltration Local infiltration anesthesia performed by surgeon during the operation Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative visual analog scale (VAS) score
Postoperative pain assessment will be performed using the VAS score (VAS 0 = no pain, VAS 10 = most severe pain possible). The VAS scores will be recorded at postoperative 0, 1, 3, 6, 9, and 12 hours.
Measured: postoperative 0, 1, 3, 6, 9, and 12 hours
Secondary outcomes (3)
analgesia consumption
postoperative
Measured: 12 hours
length of hospital
recorded at the following time after surgery
Measured: 4 days
analgesia consumption
intraoperative
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Jul 2017
- Primary completion1 Mar 2018
- Study completion1 May 2018
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 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, Netherlands: Ministry of Health, Welfare and Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857386
- Sponsor's protocol ID
- 10/09
- Status last verified
- Apr 2019
- First submitted
- 18 Dec 2018
- Last updated
- 30 Apr 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 22939099
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Analgesia for Breast Reduction Surgery
- ClinicalTrials.gov ID
- NCT03857386
- Acronym / sponsor ID
- 10/09
- Conditions
- Nerve Blocks, Breast Surgery, Postoperative Pain
- Keywords
- pectoral nerve block (PECS block), breast reduction surgery, ultrasonography, postoperative pain, VAS score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 28 Feb 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 efficacy of PECS block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia.
Detailed description
Pectoral nerve block (PECS 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 especially in breast cancer surgery and subpectoral breast prosthesis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS group | – | Procedure: PECS groupPreoperative bilateral PECS I + PECS II Pecs block performed by anaesthetist using ultrasound guidance in plane approach |
| Control group | – | Procedure: Control groupBilateral local anesthesia infiltration Local infiltration anesthesia performed by surgeon during the operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients with ASA I-II, 18-65 years old, with a BMI ≤ 40 kg/m2 and undergoing elective breast reduction operation under general anesthesia.
Key inclusion criteria (3 listed)
- American Society of Anesthesiology (ASA) I-II
- body mass index (BMI) ≤40 kg/m2
- elective bilateral breast reduction surgery
Key exclusion criteria (9 listed)
- declining to give written informed consent
- ASA III and above
- under 18 years of age or over 65 years of age
- history of allergy against to the local anesthetics,
- controendication 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 groupAlso: Regional anesthesia in breast surgeryPecs block performed using ultrasound guidance | Procedure or surgery | PECS group |
| Control groupAlso: Regional anesthesia in breast surgeryLocal infiltration anesthesia performed during the operation | Procedure or surgery | Control group |
Primary outcome
postoperative visual analog scale (VAS) score
Time frame: postoperative 0, 1, 3, 6, 9, and 12 hours
Postoperative pain assessment will be performed using the VAS score (VAS 0 = no pain, VAS 10 = most severe pain possible). The VAS scores will be recorded at postoperative 0, 1, 3, 6, 9, and 12 hours.
3 secondary outcomes
analgesia consumption
Time frame: 12 hours
length of hospital
Time frame: 4 days
analgesia consumption
Time frame: during the surgery
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 30 Apr 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.
- 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
Netherlands: Ministry of Health, Welfare and Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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 30 Apr 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. 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?
postoperative visual analog scale (VAS) score (time frame: postoperative 0, 1, 3, 6, 9, and 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 NCT03857386, 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 30 Apr 2019.