1

Introduction

Breast cancer is a prevalent medical condition that affects females. It constitutes over 10 % of new cancer diagnoses annually, and approximately one in every eight women will experience breast cancer throughout their lifetime.

Modified radical mastectomy surgery is a common surgical treatment for breast cancer. This type of surgery is known for causing acute postoperative pain that demands appropriate pain control as it may lead to post mastectomy syndrome, which is a type of chronic pain that persists for months in 25 % to 60 % of patients undergoing breast surgeries. Various regional nerve blocks, including paravertebral block, have been considered as an analgesic modality for breast surgeries.

ESPB is a more recent myofascial plane block initially reported by Forero et al. who utilized it to relieve thoracic neuropathic pain. Later researches have demonstrated that ESPB could promote effective pain control for breast surgeries.

As a part of multimodal analgesia, ESBP could be achieved by administering the local anesthetics within anatomical space between the tip of the transverse process and erector spinae muscle. Since erector spinae muscles are located anatomically along the thoracoabdominal fascia, ESBP could provide a widespread craniocaudal extension.

Ultrasound imaging is a simple and noninvasive technique that aids in capturing the anatomical structures of the target area. It facilitates real-time visualization of the anesthesia puncture needle in relation to the nerve of interest, blood vessels, and other relevant structures, Thereby minimizing the rate of complications.

Different adjuvants, such as clonidine, opioids, steroids, dexmedetomidine, and neostigmine, were combined with local anesthetics to enhance the effectiveness and prolong the duration of peripheral nerve block effects.

In our study, we used fentanyl as an additive to ESPB, which is a potent opioid agonist with a rapid onset of action. When injected intrathecally, fentanyl provides adequate analgesia without hemodynamic instability, making the drug a preferred option over other opioids due to its better safety profile.

2

Aim of the work

Our goal is to evaluate the outcome of incorporating fentanyl into bupivacaine in US-guided ESPB for modified radical mastectomy surgeries, using postoperative opioids requirements and visual analogue score.

3

Patients and method

This randomized, prospective, single-blinded study was conducted at Ain Shams University Hospitals over a period of one year, beginning in July 2022. The trial received approval from the Research Ethics Committee at the Faculty of Medicine, AinShams University, Cairo, Egypt (FMASU MD150/2022). It was recorded on the Pan Africa Clinical Trial Registry with the ID PACTR202210738525707. The study was conducted following the CONSORT 2010 guidelines. All participants gave written informed consent before involvement in the study.

Our study involved sixty female individuals of ASA grade I and II arranged for modified radical mastectomy surgery and had a BMI < 35 kg/m ² , with ages ranging from 30 to 65 years.

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    Exclusion criteria:

    
    
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    Patients aged <30 years or > 65 years.

    
    
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    Patients of physical status ASA grade III or above.

    
    
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    Patient refusal.

    
    
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    Patients had a history of coagulopathies or bleeding disorders.

    
    
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    Patients had a history of hypersensitivity to any of the studied drugs.

    
    
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    Patients had a BMI ≥ 35 kg/m ² due to technical difficulties administering the block.

    
    
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    Hypersensitivity or contraindication to any of the study drugs.

    
    
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    Patients had psychological disorders that may interfere with the proper assessment of pain.

  
  

The participants were assigned into two equal groups utilizing a computer-generated randomization method, each with 30 individuals. The participants received either ESPB with fentanyl only (group 1) or received ESPB with fentanyl and bupivacaine (group 2) according to a random number list that was generated by the computer. Patients only were blinded to the group assignment.

At the clinic of anesthesia, pre-operative evaluation of all patients was achieved, including gathering their medical history, fasting hours, clinical inspection, and standard laboratory testing (e.g., complete blood count, coagulation profile, AST, ALT, urea, creatinine, and viral markers). The patients were provided with a detailed explanation of the procedure, and their consent was obtained before participation. All patients had prior familiarity with the visual analogue score (VAS), which is a 100 mm long continuous line. The left end of the VAS represents the absence of pain (scored as zero), while the right end corresponds to the highest level of pain imaginable (scored as 10 cm).

Once the patient arrived at the operating room, 20 gauge intravenous access was set up on the contralateral side of the surgery, and anti-stress measures IV ondansetron (4 mg) and IV pantoprazole (40 mg) were given. Lactated ringer solution was administered at a rate of 10 ml/kg/hr. Additionally, the patient received an increment of 1 mg of midazolam for sedation. The patient’s perioperative vital signs were continuously monitored using ASA standard monitors. Initiation of general anesthesia was achieved using IV fentanyl (1–2 ug/kg), propofol (1–2 mg/kg), and atracurium (0.5 mg/kg). After insertion of the endotracheal tube, general anesthesia was maintained using isoflurane MAC(1–2 %) and atracurium (0.1 mg/kg) guided by a nerve stimulator.

Following surgery, the patient was positioned laterally. Skin sterilization was done first, and then a high-frequency linear probe was placed in a longitudinal parasagittal plane approximately 3 c.m from the midline. After identifying the erector spinae muscle above the T5 transverse process, an echogenic 22G-10 cm nerve block needle was advanced in a cranio-caudal manner until it contacted the transverse process tip. After slight needle retraction, the local anesthetics were injected after negative aspiration to prevent intravascular injection. The dispersion of the medication within the tissue plane was then monitored utilizing ultrasound imaging. ESBP was performed unilaterally on the same side of surgery by injecting:10 ml bupivacaine 0.5 % mixed with 10 ml normal saline to achieve a total volume of 20 ml in group 1 while in group 2,10 ml bupivacaine 0.5 % mixed with 50 mcg fentanyl(1 ml) and 9 ml normal saline to reach the same total volume as group 1. The reversal of muscle relaxants was then achieved using neostigmine 0.05 mg/kg with atropine 0.02 mg/kg and the patient was extubated after regaining airway reflexes.

Afterward, the studied cases were transferred to the post-anesthesia care unit (PACU), where they underwent a one-hour observation period. A modified Aldrete score of greater than 9 was necessary to discharge the patients from PACU and transport them to the ward.

VAS (visual analogue score), heart rate, and mean arterial pressure were monitored at (0, 1, 2, 6, 12, and 24 h) postoperatively. Postoperative pain was treated with regular doses of acetaminophen, 1 g IV every 8 h, and Rescue analgesia(on-demand analgesia given to control breakthrough pain) in the form of 5 mg nalbuphine was given at the time of assessment or at any time when VAS was more than 4.

3.3

Statistical analysis

SPSS software package (IBM SPSS Statistics for Windows, version 22.0. Armonk, NY: IBM Corp., 2013) was adopted for data collection, coding, tabulation, and analysis. Mean (standard deviation) or median (Q3-Q1) were used to present numerical variables, while frequency (%) was utilized for categorical variables. Comparisons of numerical variables were accomplished with the Mann-Whitney test or t -test as applicable, while categorical variables comparisons were done using the chi-square test. Using Kaplan-Meier Survival analysis and log-rank test, The first-time rescue analgesia requirement was evaluated. Any difference with a p-value < 0.05 was regarded as having statistical significance, While a P-value <0.001 was considered highly significant. Fig. 1

CONSORT flow diagram.

4

Results

Groups 1 and group 2 did not reveal any significant statistical differences as regards demographic data (BMI, age, surgical procedure duration, and ASA score) of the studied cases, as indicated by ( Table 1 ) (p-value > 0.05).

Table 1

Comparison between the two groups as regards the demographic data.

		Group 1	Group 2	P-value
		N = 30	N = 30
Age, (years)	Mean	50.8	51.93	0.267
	Std.Deviation	3.674	3.704
BMI, (kg/m 2 )	Mean	25.83	26.50	0.396
	Std.Deviation	2.614	3.371
Duratuon of Surgery(mins)	Mean	136.67	139.33	0.611
	Std.Deviation	19.535	20.833
ASA	1.0	13(43.3 %)	11(36.7 %)	0.598
	2.0	17(56.7 %)	19(63.3 %)

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