Effect of Adding TTPB to SAPB in Breast Cancer Surgery

Trial Title: Effect of Adding TTPB to SAPB in Breast Cancer Surgery

NCT ID: NCT06082141

Condition: Acute Pain
Opioid Use

Conditions: Official terms:
Acute Pain

Conditions: Keywords:
Quality of recovery-15
Serratus anterior plan block
Transversus thoracis plan block

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Transversus thoracis plane block combined with serratus anterior plane block
Description: 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
Arm group label: Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block

Intervention type: Procedure
Intervention name: Serratus anterior plan block
Description: 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
Arm group label: Ultrasound guided serratus anterior plane block

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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Aylin Ceren Şanlı

Address:
City: Istanbul
Country: Turkey

Status: Recruiting

Contact:
Last name: Aylin Ceren Sanli, Asist Dr

Contact backup:
Last name: Aylin Ceren Sanli, Asist Dr

Phone: +0905496522412
Email: asanli@bezmialem.edu.tr

Start date: July 12, 2023

Completion date: June 2024

Lead sponsor:
Agency: Bezmialem Vakif University
Agency class: Other

Source: Bezmialem Vakif University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06082141