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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06082141
Enrollment
60
Registered
2023-10-13
Start date
2023-07-12
Completion date
2024-06-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Opioid Use

Keywords

Quality of recovery-15, Serratus anterior plan block, Transversus thoracis plan block

Brief 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. 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.

Interventions

PROCEDURETransversus thoracis plane block combined with serratus anterior plane block

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

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

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of recovery-15 (QoR-15) scoreat the end of 24 hours postoperativelyQuality of recovery-15 (QoR-15) score at 24 hours after surgery

Secondary

MeasureTime frameDescription
Postoperative opioid consumptionup to the first 24 hours postoperativelyTotal amount of morphine consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Pain intensity score0, 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.
Postoperative nausea and vomitingup to the first 24 hours postoperativelyNausea 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).
Patient satisfactionat the end of 24 hours postoperativelyPatient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)

Countries

Turkey (Türkiye)

Contacts

Primary ContactAylin Ceren Sanli, Asist Dr
asanli@bezmialem.edu.tr+0905496522412
Backup ContactSanli

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026