Pain, PostoperativeNCT05568589
Effects of Interpectoral-Pectoserratus Plane Block After Breast Cancer Surgery
An observational study of Pain, Postoperative and Disability Physical, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study: It was aimed to observe the effects of intraoperative and preoperative PECS II block on postoperative pain, amount of analgesic use and shoulder joint range of motion in patients who underwent breast cancer surgery. This research was planned as an observational study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Disability Physical, Quality of Life
- What is being tested?
- Preoperative Interpectoral - Pectoserratus Plane Block, Intraoperative Interpectoral - Pectoserratus Plane Block and Non Block
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2022to 6 Apr 2023
- How long will I take part?
- 10 Days
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Sixty patients aged >18 years old who has breast cancer surgery with intraoperative or preoperative interpectoral - pectoserratus plane block o non block will be included in the study. Patients will be randomly divided into three groups including 20 patients each, postoperative 1st hour.
Who may be able to join
- Having had a unilateral breast cancer operation
- Signing the voluntary consent form
Who cannot join
- BMI >35kg/m2 and <20kg/m2
- Having a rheumatological disease (rheumatoid arthritis, etc.),
- Having neuromuscular disease
- Having a disease that will add shoulder joint movement (arthritis, prosthesis, fracture sequela, etc.)
- Having neuropathy, alcoholism, psychiatric disorder
- Chronic opioid use
Show all 9Show fewer
- being pregnant
- Patient's refusal to use patient-controlled analgesia
- History of uncontrolled hypertension, diabetes, heart failure, liver failure, kidney failure and/or cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bakircay University Cigli Training and Research Hospital
Izmir
Ömer Faruk ALTAŞ, 1
About this study
Official title: The Effects of Intraoperative and Preoperative Interpectoral -Pectoserratus Plan Block on Postoperative Pain, Amount of Analgesic Use, and Shoulder Joint Range of Motion in Patients Who Had Breast Cancer Surgery
The aim of this study: It was aimed to observe the effects of intraoperative and preoperative PECS II block on postoperative pain, amount of analgesic use and shoulder joint range of motion in patients who underwent breast cancer surgery.
This research was planned as an observational study. For this purpose, patients who underwent breast cancer surgery in İzmir Bakırçay University Çiğli Training and Research Hospital General Surgery Clinic will be included in the study at the 1st hour after the operation. Patients who underwent preoperative Interpectoral - Pectoserratus Plan Block in the operation will be included in Group 1, patients who have been applied Interpectoral - Pectoserratus Plan Block between the muscle planes by the intraoperative surgeon will be included in Group 2, and patients who have not applied any block will be included in Group 3. Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia, adverse events (pneumothorax, nausea, vomiting, itching, hematoma, allergic reactions) and quality of life, shoulder joint range of motion, hand grip strength (also on day 1) and disability level will be measured on postoperative day 10.
Read more
H0- Preoperative interpectoral - pectoserratus plane block affects the level of postoperative pain.
H1- Preoperativeinterpectoral - pectoserratus plane block does not affect the level of postoperative pain.
H2- Intraoperative interpectoral - pectoserratus plane block affects postoperative pain level H3- Intraoperative interpectoral - pectoserratus plane blockk does not affect the level of postoperative pain.
Read the detailed description
Breast cancer is the most common type of cancer among women and the most common cause of death worldwide. While there has been a serious decrease in the mortality rate due to developments in diagnosis and treatment, there have been serious increases in functional disability and disability due to the disease. Breast cancer can lead to various functional losses due to the nature of the disease itself, radical surgical interventions and radiotherapy applications. These include shoulder dysfunction (pain and limitation of joint movement), locomotor system disorders such as upper extremity muscle strength loss and lymphedema, as well as psychological and cosmetic problems, and as a result, these problems affect the quality of life (QOL) of individuals (1).
Firstly, Blanco et al. Ultrasound-guided pectoralis nerve II block (Interpectoral and pectoserratus plan block - PECS II block), described by MD, is increasingly used for analgesia in breast surgery (2). It has been reported that PECS II block is effective in reducing postoperative pain intensity and opioid consumption (3). It is safe and relatively simple to apply as an interfascial plane block, and there is no sympathetic blockade (4). The PECS II block consists of two interfascial injections of local anesthetics: 1) between the pectoralis minor and serratus anterior muscles, 2) between the pectoralis major and pectoralis minor muscles at the level of the third rib. Local anesthetic injection into these planes; It is expected to block the lateral pectoral nerve, medial pectoral nerve, anterior branches of the thoracic intercostal nerves, and long thoracic nerves (5). Recently, the types of local anesthesia used during radical surgery may decrease the postoperative pain levels and recovery times of the patients. The effect of these intraoperative or postoperative blocks on the patients' clinical status in the postoperative period has not been compared before.
- Conditions
- Pain, Postoperative, Disability Physical, Quality of Life
- Being tested
- Preoperative Interpectoral - Pectoserratus Plane Block, Intraoperative Interpectoral - Pectoserratus Plane Block, Non Block
- Keywords
- İnterpectoral plane block, Pectoserratus plane block, Breast Cancer, PECS II Block
- 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.
Preoperative Interpectoral - Pectoserratus Plane BlockOther
Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.
Intraoperative Interpectoral - Pectoserratus Plane BlockOther
Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.
Non BlockOther
Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Interpectoral - Pectoserratus Plane Block | The block will be done by the Anesthesiologist. Receives: Other: Preoperative Interpectoral - Pectoserratus Plane Block | |
| Intraoperative Interpectoral - Pectoserratus Plane Block | The block will be made by the surgeon. Receives: Other: Intraoperative Interpectoral - Pectoserratus Plane Block | |
| Non Block | will not be blocked. Receives: Other: Non Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Tramadol consumption in the first 24 hours after surgery
Measured: 24 hours
Secondary outcomes (6)
NRS scores
NRS scores in the first 24 hours after surgery
Measured: 1., 2., 6., 12., 24. hour
Quality of Recovery
QoR-15 questionairre QoR-15 questionairre
Measured: 24th hours
The disability levels of the patients due to shoulder dysfunction.
The Shoulder Pain and Disability Index questionnaire will be used to determine The disability levels of the patients due to shoulder dysfunction. (Quick dash)
Measured: 10th day
Hand grip muscle strength.
Hand grip muscle strength will be measured with a handheld dynamometer.
Measured: 24th hour, 10th day
Quality of Life (Short Form 36)
The SF-36 Quality of Life scale will be used to assess quality of life.
Measured: 24th hour, 10th day
Shoulder joint range of motion
Shoulder joint range of motion will be measured with a goniometer.
Measured: 10th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start6 Oct 2022 (estimated)
- Primary completion6 Jan 2023 (estimated)
- Study completion6 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Faruk Altas, Izmir Bakircay University
- Investigators
- Ömer Faruk Altaş, 1, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568589
- Sponsor's protocol ID
- 712
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2022
- Last updated
- 5 Oct 2022
- 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 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intraoperative and Preoperative Interpectoral -Pectoserratus Plan Block on Postoperative Pain, Amount of Analgesic Use, and Shoulder Joint Range of Motion in Patients Who Had Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT05568589
- Acronym / sponsor ID
- 712
- Conditions
- Pain, Postoperative, Disability Physical, Quality of Life
- Keywords
- İnterpectoral plane block, Pectoserratus plane block, Breast Cancer, PECS II Block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 6 Oct 2022 (estimated)
- Primary completion
- 6 Jan 2023 (estimated)
- Study completion
- 6 Apr 2023 (estimated)
- First posted
- 5 Oct 2022 (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 aim of this study: It was aimed to observe the effects of intraoperative and preoperative PECS II block on postoperative pain, amount of analgesic use and shoulder joint range of motion in patients who underwent breast cancer surgery.
This research was planned as an observational study. For this purpose, patients who underwent breast cancer surgery in İzmir Bakırçay University Çiğli Training and Research Hospital General Surgery Clinic will be included in the study at the 1st hour after the operation. Patients who underwent preoperative Interpectoral - Pectoserratus Plan Block in the operation will be included in Group 1, patients who have been applied Interpectoral - Pectoserratus Plan Block between the muscle planes by the intraoperative surgeon will be included in Group 2, and patients who have not applied any block will be included in Group 3. Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia, adverse events (pneumothorax, nausea, vomiting, itching, hematoma, allergic reactions) and quality of life, shoulder joint range of motion, hand grip strength (also on day 1) and disability level will be measured on postoperative day 10.
H0- Preoperative interpectoral - pectoserratus plane block affects the level of postoperative pain.
H1- Preoperativeinterpectoral - pectoserratus plane block does not affect the level of postoperative pain.
H2- Intraoperative interpectoral - pectoserratus plane block affects postoperative pain level H3- Intraoperative interpectoral - pectoserratus plane blockk does not affect the level of postoperative pain.
Detailed description
Breast cancer is the most common type of cancer among women and the most common cause of death worldwide. While there has been a serious decrease in the mortality rate due to developments in diagnosis and treatment, there have been serious increases in functional disability and disability due to the disease. Breast cancer can lead to various functional losses due to the nature of the disease itself, radical surgical interventions and radiotherapy applications. These include shoulder dysfunction (pain and limitation of joint movement), locomotor system disorders such as upper extremity muscle strength loss and lymphedema, as well as psychological and cosmetic problems, and as a result, these problems affect the quality of life (QOL) of individuals (1).
Firstly, Blanco et al. Ultrasound-guided pectoralis nerve II block (Interpectoral and pectoserratus plan block - PECS II block), described by MD, is increasingly used for analgesia in breast surgery (2). It has been reported that PECS II block is effective in reducing postoperative pain intensity and opioid consumption (3). It is safe and relatively simple to apply as an interfascial plane block, and there is no sympathetic blockade (4). The PECS II block consists of two interfascial injections of local anesthetics: 1) between the pectoralis minor and serratus anterior muscles, 2) between the pectoralis major and pectoralis minor muscles at the level of the third rib. Local anesthetic injection into these planes; It is expected to block the lateral pectoral nerve, medial pectoral nerve, anterior branches of the thoracic intercostal nerves, and long thoracic nerves (5). Recently, the types of local anesthesia used during radical surgery may decrease the postoperative pain levels and recovery times of the patients. The effect of these intraoperative or postoperative blocks on the patients' clinical status in the postoperative period has not been compared before.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preoperative Interpectoral - Pectoserratus Plane Block | – | Other: Preoperative Interpectoral - Pectoserratus Plane BlockThe block will be done by the Anesthesiologist. |
| Intraoperative Interpectoral - Pectoserratus Plane Block | – | Other: Intraoperative Interpectoral - Pectoserratus Plane BlockThe block will be made by the surgeon. |
| Non Block | – | Other: Non Blockwill not be blocked. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sixty patients aged >18 years old who has breast cancer surgery with intraoperative or preoperative interpectoral - pectoserratus plane block o non block will be included in the study. Patients will be randomly divided into three groups including 20 patients each, postoperative 1st hour.
Key inclusion criteria (2 listed)
- Having had a unilateral breast cancer operation
- Signing the voluntary consent form
Key exclusion criteria (9 listed)
- BMI >35kg/m2 and <20kg/m2
- Having a rheumatological disease (rheumatoid arthritis, etc.),
- Having neuromuscular disease
- Having a disease that will add shoulder joint movement (arthritis, prosthesis, fracture sequela, etc.)
- Having neuropathy, alcoholism, psychiatric disorder
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 |
|---|---|---|
| Preoperative Interpectoral - Pectoserratus Plane BlockPain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day. | Other | Preoperative Interpectoral - Pectoserratus Plane Block |
| Intraoperative Interpectoral - Pectoserratus Plane BlockPain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day. | Other | Intraoperative Interpectoral - Pectoserratus Plane Block |
| Non BlockPain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day. | Other | Non Block |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours
Tramadol consumption in the first 24 hours after surgery
6 secondary outcomes
NRS scores
Time frame: 1., 2., 6., 12., 24. hour
Quality of Recovery
Time frame: 24th hours
The disability levels of the patients due to shoulder dysfunction.
Time frame: 10th day
Hand grip muscle strength.
Time frame: 24th hour, 10th day
Quality of Life (Short Form 36)
Time frame: 24th hour, 10th day
Shoulder joint range of motion
Time frame: 10th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- 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.
Ömer Faruk Altaş, 1 principal investigator
Izmir Bakircay University
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 Pain, Postoperative and Disability Physical, run by Izmir Bakircay University 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 2 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: status not confirmed, as of the sponsor's last update on 5 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ömer Faruk Altaş, 1 (+905366533992, omerfarukaltas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 24 hours). 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 5 Oct 2022.