Effect of Adding TTPB to SAPB in Breast Cancer Surgery

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082141
• Other study ID #: E.116140
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Bezmialem Vakif University
• Contact: Aylin Ceren Sanli, Asist Dr
• Phone: +0905496522412
• Email: asanli[@]bezmialem.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
Turkey	Aylin Ceren Sanli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative opioid consumption	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
Secondary	Pain intensity score	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.
Secondary	Postoperative nausea and vomiting	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
Secondary	Patient satisfaction	Patient satisfaction measured using a numeric rating scale 0 to 10 (0 = unsatisfied; 10 =very satisfied)	at the end of 24 hours postoperatively