Effect of Adding TTPB to SAPB in Breast Cancer Surgery

NCT06082141 | Unknown

• 1 other identifier: E.116140
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Quality of recovery-15 (QoR-15) score

  Quality of recovery-15 (QoR-15) score at 24 hours after surgery

  at the end of 24 hours postoperatively

Secondary Outcomes (4)

• Postoperative opioid consumption

  up to the first 24 hours postoperatively

• Pain intensity score

  0, 2, 6, 12, 24 hours postoperatively.

• Postoperative nausea and vomiting

  up to the first 24 hours postoperatively

• Patient satisfaction

  at the end of 24 hours postoperatively

Study Arms (2)

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

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

Procedure: Transversus thoracis plane block combined with serratus anterior plane block

Interventions

Transversus thoracis plane block combined with serratus anterior plane block 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

Combination of ultrasound-guided serratus anterior plane block and transversus thoracis plane block

Serratus anterior plan block 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

Ultrasound guided serratus anterior plane block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II-III
• BMI 20 to 35 kg / m2
• Patients scheduled for breast cancer surgery procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Aylin Ceren Şanlı

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Aylin Ceren Sanli, Asist Dr

CONTACT

+0905496522412; asanli@bezmialem.edu.tr

Sanli

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist Dr

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 13, 2023
• Study Start: July 12, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

TU (1)