Effect of Adding TTPB to SAPB in Breast Cancer Surgery

NCT ID: NCT06082141

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2024-06-30

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.

Conditions

Acute Pain; Opioid Use

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Serratus anterior plan block

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Transversus thoracis plane block combined with serratus anterior plane block

Intervention Type: PROCEDURE

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

Interventions

Transversus 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

Intervention Type: PROCEDURE

Serratus anterior plan block

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Aylin Ceren Sanli

Asist Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aylin Ceren Şanlı

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Aylin Ceren Sanli, Asist Dr

Role: CONTACT

Phone: +0905496522412

Email: asanli@bezmialem.edu.tr

Sanli

Role: CONTACT

Facility Contacts

Aylin Ceren Sanli, Asist Dr

Role: primary

Aylin Ceren Sanli, Asist Dr

Role: backup

Other Identifiers

E.116140

Identifier Type: -

Identifier Source: org_study_id