Acute PainNCT06082141
Effect of Adding TTPB to SAPB in Breast Cancer Surgery
A study testing Transversus thoracis plane block combined with serratus anterior plane block and Serratus anterior plan block in people with Acute Pain and Opioid Use, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common malignancy in women worldwide. Even minor breast surgery can cause significant postoperative pain (PP). PP can turn into chronic pain in 25-40% of cases. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Acute Pain, Opioid Use
- What is being tested?
- Transversus thoracis plane block combined with serratus anterior plane block and Serratus anterior plan block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jul 2023to Jun 2024
- 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
- ASA I-II-III
- BMI 20 to 35 kg / m2
- Patients scheduled for breast cancer surgery procedure
Who cannot join
- Patients with previously known allergies to the drugs to be used in the study,
- Infection near the puncture site,
- Patients with previous symptoms of neurological disease (TIA, syncope, dementia, etc.)
- Known coagulation disorders,
- Alcohol and drug use,
- Disorder of consciousness,
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- Opioid use equal to or greater than 60 mg oral morphine equivalent per day,
- Patients with pre-existing neuropathic pain,
- Liver failure, renal failure, cardiac failure
- Morbid obesity (body mass index [BMI] > 35 kg m-2)
- Uncontrolled diabetes mellitus
- Women during pregnancy or breastfeeding
- Not approving the informed consent form
Trial locations and contacts
1 site in 1 country.
Sanli contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aylin Ceren Şanlı
Istanbul
Aylin Ceren Sanli, Asist Dr
Aylin Ceren Sanli, Asist Dr, +0905496522412, asanli@bezmialem.edu.tr
About this study
Official title: Contribution of Transversus Thoracis Plane Block in Combination With Serratus Anterior Plane Block to the Quality of Recovery After Breast Cancer Surgery: a Randomized Controlled Trial
Breast cancer is the most common malignancy in women worldwide. Even minor breast surgery can cause significant postoperative pain (PP). PP can turn into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delayed wound healing, prolonged hospital stay, increased opioid use and side effects, and high cost of care.
Opioid use remains the mainstay of postoperative analgesia. Opioids, especially morphine, inhibit both cellular and humoral immune functions. This effect may be responsible for the high rates of local recurrence and/or metastasis after surgery. Additionally, studies have shown that perioperative opioid use is associated with social abuse. This demonstrates the importance of reducing perioperative opioid use. Currently, multimodal analgesia based on nerve block is being widely investigated and has shown encouraging clinical results.
Read more
Numerous regional analgesic techniques have been investigated in breast cancer surgery, including intercostal nerve block, thoracic epidural anesthesia, and paravertebral block. Compared with general anesthesia alone, it reduces the postoperative pain score even after a single-shot injection for up to 72 hours, reduces opioid consumption, improves the quality of patient recovery, and suppresses the development or reduces the severity of chronic pain.
Serratus anterior plane block (SAPB) is reported to be effective in perioperative pain management of breast cancer surgeries. The important problem of SAPB block is that it is insufficient to block the anterior cutaneous branches of the intercostal nerves. Therefore, intravenous analgesia is required. Thoracic transversus muscle plane block (TTPB) is a recently described fascial plane block used to anesthetize the anterior cutaneous branches of the intercostal nerves from T2-T6. Its effectiveness has been demonstrated for breast surgery and median sternotomy.
In our study, we will provide postoperative analgesia in patients undergoing breast surgery by applying the serratus anterior block in combination with the transversus thoracis plane block. Since we avoid complicated analgesia methods such as paravertebral block, the risk of complications will be reduced.
In this study, we aimed to compare the effectiveness of the combination of SAPB and TTPB with SAPB performed alone in breast cancer surgery.
- Conditions
- Acute Pain, Opioid Use
- Being tested
- Transversus thoracis plane block combined with serratus anterior plane block, Serratus anterior plan block
- Keywords
- Quality of recovery-15, Serratus anterior plan block, Transversus thoracis plan block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus thoracis plane block combined with serratus anterior plane blockProcedure or surgery
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl under US-guidance
Serratus anterior plan blockProcedure or surgery
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 10 ml NaCl under US-guidance
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided serratus anterior plane block | Active comparator | SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 10 ml NaCl Receives: Procedure: Serratus anterior plan block |
| Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block | Active comparator | SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl Receives: Procedure: Transversus thoracis plane block combined with serratus anterior plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery-15 (QoR-15) score
Quality of recovery-15 (QoR-15) score at 24 hours after surgery
Measured: at the end of 24 hours postoperatively
Secondary outcomes (4)
Postoperative opioid consumption
Total amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Measured: up to the first 24 hours postoperatively
Pain intensity score
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) at 0, 2, 6, 12, 24 hours postoperatively.
Measured: 0, 2, 6, 12, 24 hours postoperatively.
Postoperative nausea and vomiting
Nausea and vomiting intensity score measured by numeric rank score (0:no nausea and no vomiting, 1: have nausea, no vomiting, 2: once vomiting, 3: two or more vomiting).
Measured: up to the first 24 hours postoperatively
Patient satisfaction
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Measured: at the end of 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start12 Jul 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Ceren Sanli, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082141
- Sponsor's protocol ID
- E.116140
- Status last verified
- Nov 2023
- First submitted
- 8 Oct 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Transversus Thoracis Plane Block in Combination With Serratus Anterior Plane Block to the Quality of Recovery After Breast Cancer Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06082141
- Acronym / sponsor ID
- E.116140
- Conditions
- Acute Pain, Opioid Use
- Keywords
- Quality of recovery-15, Serratus anterior plan block, Transversus thoracis plan block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Oct 2023 (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.
Breast cancer is the most common malignancy in women worldwide. Even minor breast surgery can cause significant postoperative pain (PP). PP can turn into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delayed wound healing, prolonged hospital stay, increased opioid use and side effects, and high cost of care.
Opioid use remains the mainstay of postoperative analgesia. Opioids, especially morphine, inhibit both cellular and humoral immune functions. This effect may be responsible for the high rates of local recurrence and/or metastasis after surgery. Additionally, studies have shown that perioperative opioid use is associated with social abuse. This demonstrates the importance of reducing perioperative opioid use. Currently, multimodal analgesia based on nerve block is being widely investigated and has shown encouraging clinical results.
Numerous regional analgesic techniques have been investigated in breast cancer surgery, including intercostal nerve block, thoracic epidural anesthesia, and paravertebral block. Compared with general anesthesia alone, it reduces the postoperative pain score even after a single-shot injection for up to 72 hours, reduces opioid consumption, improves the quality of patient recovery, and suppresses the development or reduces the severity of chronic pain.
Serratus anterior plane block (SAPB) is reported to be effective in perioperative pain management of breast cancer surgeries. The important problem of SAPB block is that it is insufficient to block the anterior cutaneous branches of the intercostal nerves. Therefore, intravenous analgesia is required. Thoracic transversus muscle plane block (TTPB) is a recently described fascial plane block used to anesthetize the anterior cutaneous branches of the intercostal nerves from T2-T6. Its effectiveness has been demonstrated for breast surgery and median sternotomy.
In our study, we will provide postoperative analgesia in patients undergoing breast surgery by applying the serratus anterior block in combination with the transversus thoracis plane block. Since we avoid complicated analgesia methods such as paravertebral block, the risk of complications will be reduced.
In this study, we aimed to compare the effectiveness of the combination of SAPB and TTPB with SAPB performed alone in breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided serratus anterior plane block | Active comparator | Procedure: Serratus anterior plan blockSAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 10 ml NaCl |
| Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block | Active comparator | Procedure: Transversus thoracis plane block combined with serratus anterior plane blockSAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II-III
- BMI 20 to 35 kg / m2
- Patients scheduled for breast cancer surgery procedure
Key exclusion criteria (13 listed)
- Patients with previously known allergies to the drugs to be used in the study,
- Infection near the puncture site,
- Patients with previous symptoms of neurological disease (TIA, syncope, dementia, etc.)
- Known coagulation disorders,
- Alcohol and drug use,
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 |
|---|---|---|
| Transversus thoracis plane block combined with serratus anterior plane blockSAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 5 ml 0.5% bupivacaine + 5 ml NaCl under US-guidance | Procedure or surgery | Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block |
| Serratus anterior plan blockSAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl under US-guidance, TTP block will be made with 10 ml NaCl under US-guidance | Procedure or surgery | Ultrasound guided serratus anterior plane block |
Primary outcome
Quality of recovery-15 (QoR-15) score
Time frame: at the end of 24 hours postoperatively
Quality of recovery-15 (QoR-15) score at 24 hours after surgery
4 secondary outcomes
Postoperative opioid consumption
Time frame: up to the first 24 hours postoperatively
Pain intensity score
Time frame: 0, 2, 6, 12, 24 hours postoperatively.
Postoperative nausea and vomiting
Time frame: up to the first 24 hours postoperatively
Patient satisfaction
Time frame: at the end of 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Sanli contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus thoracis plane block combined with serratus anterior plane block and Serratus anterior plan block in people with Acute Pain and Opioid Use, run by Bezmialem Vakif 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 3 inclusion and 13 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 29 Nov 2023. 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 Aylin Ceren Sanli, Asist Dr (+0905496522412, asanli@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery-15 (QoR-15) score (time frame: at the end of 24 hours postoperatively). 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 29 Nov 2023.