3.1. Patients
This comparative study included 60 patients scheduled to undergo endoscopic sinus surgery. Approval was obtained from the local research ethics committee of the Faculty of Medicine, Ain Shams University, Egypt (FMASU R 97/2022). This trial was prospectively registered with the Clinical Trial Registry (PACTR202206548559545) on June 15, 2022, initiated on June 20, 2022, and concluded on November 15, 2022.
After obtaining written informed consent, patients were allocated to one of two groups using a random number generator in sealed envelopes. The first group (MNB group) was scheduled to undergo ultrasound-guided maxillary nerve block for pain management (n = 30). The other group (control group) was designated to receive multimodal analgesia with the use of opiates (n = 30).
Patients aged 20 - 60 years of both genders with American Society of Anesthesiologists (ASA) physical statuses of I or II who were candidates for FESS (for the correction of refractory, resistant chronic rhinosinusitis and/or polyps) were included in the study. Exclusion criteria included uncontrolled hypertension, cardiovascular or cerebrovascular disease, and chronic renal disease. Additionally, patients with a history of allergy to local anesthetics, opioid consumption, or those unwilling to provide informed consent were excluded from the study.
Upon admission to the operating room, standard basic anesthesia monitoring was applied to patients. After pre-oxygenation using an O2/Air mixture (FiO2 = 0.8) for 3 - 5 min, general anesthesia was induced with intravenous 2 - 2.5mg/kg of propofol, 2µg/kg of fentanyl, and 0.6 mg/kg rocuronium, followed by tracheal intubation.
Patients were maintained on isoflurane in oxygen, and mechanical ventilation was adjusted to keep SaO2 > 95 % and end-tidal CO2 between 35 - 45 mmHg. One gram of paracetamol infusion was administered as part of the analgesia. All patients received 8 mg of dexamethasone as prophylaxis against airway edema, as well as 8 mg of ondansetron as an antiemetic. For the operation, patients were positioned in the reverse Trendelenburg position at an angle of 15Ëš. A decongestant in the form of epinephrine 1:200,000 was administered by the surgeon into the nasal cavity.
Following induction of anesthesia, maxillary nerve block was administered to patients in the MNB group by the most experienced anesthetist present. This was followed by the skin incision. The skin was disinfected with 2 % chlorhexidine in 70 % alcohol, and an 8 to 13 - MHz linear-array ultrasound transducer (TOSHIBA, Model USAP-770A, JAPAN) was placed in the infrazygomatic area, (
10) with an inclination of 45Ëš in the transverse plane as shown in
Figure 1. A flange of a 20-gauge needle was inserted perpendicular to the skin at the frontozygomatic angle (bounded by the superior edge of the zygomatic arch below and the posterior orbital edge forward), and advanced to the greater wing of the sphenoid. The needle was then redirected and advanced to the pterygopalatine fossa (PPF). Subsequently, aspiration was conducted, and then local anesthetic in the form of 1.5 mL of 0.5 % bupivacaine with an added adjuvant of 1 mL of dexamethasone (4 mg) in PPF was administered. This combination was deemed sufficient to be efficacious and safe during the block procedure (
8) (see
Figure 2).
The ultrasound probe in the infrazygomatic area, with an inclination of 45 and the needle at the frontozygomatic angle and redirected to the PPF
Ultrasound imaging for the PPF after injection of the local anaesthetics
At the end of surgery, patients were extubated and transferred to the post-anesthesia care unit (PACU). Discharge was based on the Post-Anesthesia Discharge Scoring criteria (
11).
Postoperative pain management for all patients started with the immediate infusion of 1 gm of paracetamol. Paracetamol infusion was readministered, if needed, every 8 hours. For the control group, 30 mg of intravenous ketorolac was administered and readministered, if needed, after 12 hours.
Postoperative pain was evaluated in both groups using the NRS pain score. Patients were asked to choose a number between 0 and 10 that best reflected the intensity of their pain, where zero represented 'no pain at all' and 10 represented 'the worst pain ever experienced'. Any patient with an NRS score of 4 or more received 10mg/70kg of nalbuphine, administered intravenously as rescue analgesia.
The hemostatic agent introduced at the end of surgery was removed 36 hours after the operation. Removal was understandably painful and, in most cases, required analgesia.
3.2. Measured Data
Demographic data, including age, gender, body mass index (BMI), and ASA status, were carefully recorded. Measurements of systemic hemodynamics, including patient heart rate and median blood pressure, were recorded throughout the surgery, upon admittance to the PACU, and at 2, 6, and 12 hours postoperatively. Results of pain assessment using the NRS pain score were recorded immediately after induction of anesthesia, upon admittance to the PACU, and at 2, 6, 12, 24, 36, and 48 hours postoperatively. The NRS pain score, as well as any required analgesia, were both recorded at the time of removal of the hemostatic agent. Total rescue analgesia and postoperative complications (headaches, nausea/vomiting, and bleeding) were diligently recorded during the first 48 hours. Lastly, patient satisfaction was assessed and carefully recorded. Patients responded to relevant questions by selecting responses ranging from 'Not satisfied' = 1, 'Less satisfied' = 2, 'Quite satisfied' = 3, 'Satisfied' = 4, to 'Very satisfied' = 5.
The primary goal of the study was to evaluate the efficacy of MNB for FESS by assessing pain at admittance to the PACU and at 2, 6, 12, 24, 36, and 48 hours postoperatively, and comparing pain scores during the removal of the hemostatic agent in the two groups. Our secondary goals were to assess each of the following: Total rescue analgesia required; postoperative complications during the first 48 hours; and patient satisfaction.