- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06082141
Effect of Adding TTPB to SAPB in Breast Cancer Surgery
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aylin Ceren Sanli, Asist Dr
- Phone Number: +0905496522412
- Email: asanli@bezmialem.edu.tr
Study Contact Backup
- Name: Sanli
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Aylin Ceren Şanlı
-
Contact:
- Aylin Ceren Sanli, Asist Dr
- Phone Number: +0905496522412
- Email: asanli@bezmialem.edu.tr
-
Contact:
- Aylin Ceren Sanli, Asist Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA I-II-III
- BMI 20 to 35 kg / m2
- Patients scheduled for breast cancer surgery procedure
Exclusion Criteria:
- 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,
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ultrasound guided serratus anterior plane block
SAP block will be made with 10 ml 0.5% bupivacaine + 10 ml NaCl TTP block will be made with 10 ml NaCl
|
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
|
Active Comparator: Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at the end of 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative opioid consumption
Time Frame: up to the first 24 hours postoperatively
|
Total amount of morphine consumption during the first 24 hours after surgery.
Patient controlled analgesia to be inserted.
|
up to the first 24 hours postoperatively
|
Postoperative nausea and vomiting
Time Frame: up to the first 24 hours postoperatively
|
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).
|
up to the first 24 hours postoperatively
|
Patient satisfaction
Time Frame: at the end of 24 hours postoperatively
|
Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)
|
at the end of 24 hours postoperatively
|
Pain intensity score
Time Frame: 0, 2, 6, 12, 24 hours postoperatively.
|
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.
|
0, 2, 6, 12, 24 hours postoperatively.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.116140
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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