Serratus Plane Plus Pectoral I Block Versus Serratus Plane Block for Perioperative Analgesia in Breast Cancer Surgery

NCT ID: NCT03899545

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-06
• Study Completion Date: 2019-09-20

Brief Summary

Breast cancer is the most common malignancy in women at worldwide. Even a minor breast surgery can cause significant postoperative pain (PP) (1). PP could be converted into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delay in wound healing, prolonged hospital stay, increased opioid use, increased side effects and high cost of care. For these reasons, regional anesthetic techniques are recommended for effective PP management. Some of recent studies suggest that ultrasound-guided pectoral I (PI), pectoral II (PII) and serratus plan block (SPB) may be an alternative to thoracic epidural analgesia and paravertebral block applications because of the ease of administration, low side effect profile and adequate analgesia in breast surgery. (2,3).

Detailed Description

In breast surgeries, the serratus plane block has recently been described and rapidly became popular. The serratus plane block is called the modified pectoral II block. Local anesthetic drugs are injected onto the serratus muscle by targeting thoracodorsal nerve, thoracicus longus nerve, lateral and anterior branches of the T2-T9 intercostal nerves. In the pectoral I (Pecs I) block, the medial and lateral pectoral nerves of the brachial plexus are targeted. Additionally, Pecs I block can be effective for analgesia in axillary dissection. In the literature, there are studies comparing pectoral I + II blocks and serratus plane block in terms of analgesic efficacy in breast surgery. The aim of this study was to evaluate the postoperative analgesic efficiency of serratus plane block and serratus plan block plus pectoral I block combination.

Participans will be informed about the potential benefits and complications after the study protocol has been fully and thoroughly explained. After premedication with 0.03 mg / kg iv midazolam, participans will be noninvasively monitored by taking into the operating room (heart rate, blood pressure, pulse oximetry). Anesthesia induction will delivered with fentanyl 1mcg / kg, propofol 1.5-2 mg / kg and rocuronium 0.5 mg / kg. The maintenance of anesthesia will be achieved by infusion of sevoflurane 1-3% in 50% O2/50% medical air. The depth of anesthesia will be evaluated with bispectral index monitoring and will be kept between 40 and 60.. Thirty minutes before end of the surgery, all patients were intravenously administered 20 mg tenoxicam HCl and 1gr paracetamol.

SPB plus Pecs I block technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.

SPB technique: Bupivacaine/lidocaine mixture will be injected onto the serratus muscle.

After the surgery, 1 g paracetamol was intravenously administered once every 8 h. Postoperative pain was assessed using VAS (VAS 0 = no pain, VAS 10 = most severe pain ). Morphine 0.1mg / kg will be used as rescue analgesic drug.Duration at PACU was recorded right from 0 h. VAS scores at 0, 1,2, 6, 12 and 24 h were recorded. PONV was evaluated using a numeric ranking scale (0 = no PONV, 1 = mild nausea, 2 = severe nausea or vomiting once attack, and 3 = vomiting more than once attack). If PONV score was >2, the antiemetic metoclopramide Hcl 10mg was intravenously administered.

Conditions

Postoperative Pain; Postoperative Nausea; Patient Satisfaction; Narcotic Use

Study Design

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

Study Groups

Serratus Plane Block

Serratus plane block will be applied after induction of general anesthesia.

Group Type: EXPERIMENTAL

Serratus Plane Block

Intervention Type: OTHER

0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle

Serratus Plane Block plus Pectoral I block

Serratus plane plus pectoral I block will be applied after induction of general anesthesia.

Group Type: ACTIVE_COMPARATOR

Serratus Plane Block plus Pectoral I Block

Intervention Type: OTHER

0.5 ml / kg %0.25 Bupivacaine/ %1 lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.2/3 of the total drug will be applied for the serratus plane block and 1/3 of the total drug for the pectoral I block. If the total amount of the drug is less than 30 ml, it will be completed with isotonic saline to 30 ml.

Interventions

Serratus Plane Block

0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle

Intervention Type: OTHER

Serratus Plane Block plus Pectoral I Block

0.5 ml / kg %0.25 Bupivacaine/ %1 lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.2/3 of the total drug will be applied for the serratus plane block and 1/3 of the total drug for the pectoral I block. If the total amount of the drug is less than 30 ml, it will be completed with isotonic saline to 30 ml.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. ASA 1-2-3

2. Patients scheduled for elective surgery

Exclusion Criteria

1. Previous neurological disease symptom (TIA, syncope, dementia, etc.)

2. Allergy to drugs

3. Major cardiac disease

4. Renal failure

5. Psychiatric disease

6. Patients who refuse to participate in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Serdar Yeşiltaş

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serdar Yeşiltaş, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakıf University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yesiltas S, Turkoz A, Calim M, Yilmaz S, Esen A, Daskaya H, Karaaslan K. Comparison of serratus plane block alone and in combination with pectoral type 1 block for breast cancer surgery: a randomized controlled study. Hippokratia. 2021 Jan-Mar;25(1):8-14.

Reference Type: DERIVED

PMID: 35221650 (View on PubMed)

Other Identifiers

71306642-5/24

Identifier Type: -

Identifier Source: org_study_id