This prospective randomized study was conducted at Ain Shams University hospitals. After approval of the Research Ethics Committee of Ain Shams University (FMASU MD186/2019), the study was registered at Clinical Trials.gov (NCT04727515). The study was carried out in surgery unit at university hospitals in period between December 2019 and March 2020. After we conducted a point-by-point clarification of studied techniques, a total of 45 patients, from both sex, aged 18–40 years with body mass index less than 30 planned for elective ambulatory hand surgery with expected time less than 90 min. Patients excluded were those with allergies to local anesthetic, those with ASAIII and IV, patients who refused to participate, alcohol or drug abuse, uncooperative or not highly educated patients, living alone, patients with no telephone available, and those who have bleeding disorders or on anticoagulant drugs. Patients with preoperative obstructive sleep apnea (OSA) or any sleep disturbances, or taking any sleep medications, and patients presenting with polytrauma or undergoing emergency operation were also excluded. All patients were reviewed by anesthesiologist on the same day of surgery for any medical history, ensuring fasting at least 8 h. The anesthesia plan was discussed with the patients and the patients signed a consent form and also informed about the use of visual analog scale and Likert scale. On arrival to the operation theatre, an 18-G cannula was inserted in the nonoperative arm, and lactated ringer solution was infused at rate 6 to 8 ml/kg. Monitors as non-invasive blood pressure (NIBP), electrocardiogram, and pulse oximetry (SpO2) were applied, and basal readings were recorded. All patients were premedicated with midazolam IV 0.03 mg/kg.
Patients were divided into two equal groups at random; after exclusion of five patients, each group had twenty patients; the randomization approach was computer-generated randomized numbers, and allocation was hidden behind fixed dark envelops. The two groups were as follows: group A (n = 20) in which patients received standard general anesthesia technique, and group B (n = 20), in which patients received ultrasound-guided axillary block.
In group A, general anesthesia was induced. After preoxygenation, IV fentanyl 1–2 MIC/kg was given slowly, followed by IV propofol 1.5–2 mg/kg, which was slowly injected and titrated until the loss of verbal contact. The airway was managed with appropriately sized laryngeal airway mask. Patients continued to breathe spontaneously a mixture of isoflurane (end tidal up to 1.5 %) and oxygen in air in 50:50.
In group B, the patients received ultrasound-guided axillary block as the following: while the patient in the supine position with the arm abducted to approximately 90° with the hand resting on a pillow next to the head, and after skin disinfection, nerve location was performed using a 5-cm, 10 MHz linear probe (S-nerve ultrasound system, Fuji film sonosite, Bothell, WA). The transducer was positioned in the short axis orientation to identify the axillary artery about 1–3 cm from the skin surface. Once the artery was identified, localization of the hyperechoic median, ulnar, radial, and the musculocutaneous nerves was made. A 5-cm 22-gauge needle was advanced in line with the ultrasound beam until the tip was placed adjacent to each target nerve. Five milliliters of bupivacaine 0.5% was deposited around each target nerve.
Frequent aspiration and slow administration of local anesthetic was done to limit the risk of intravascular injection and systemic toxicity.
If no spread was seen on the ultrasound image despite local anesthetic injection, the tip of the needle may be in a vein. If this occurs, injection should be halted immediately, and the needle should be withdrawn slightly.
The limb was evaluated for block success every 3 min for the sensory block and every 5 min for the motor block. Sensory block was assessed using pinprick in the dermatomal areas supplied by the four main nerves (median nerve, radial nerve, ulnar nerve, and musculocutaneous nerve) (thenar eminence, dorsum of the hand, hypothenar eminence, and lateral side of forearm) (grade (0) sharp pain felt, grade (1) analgesia but dull sensation still felt, grade (3) complete anesthesia). The onset of sensory block was considered at grade (1) along the distribution of any of the above nerve areas while grade (2) refers to complete block. Motor block was assessed using modified Bromage scale (Malinzak 2009) for the upper limb by ability to flex the elbow and the hand against gravity. Patients were kept comfortable with arm by side, observed for signs of toxicity.
Nerve block was considered successful with regard to neurological examination when brachial plexus dermatomes were completely blocked. The block was considered to fail when sensory anesthesia was not achieved within 30 min. At the end of procedure, all patients were then transferred to postanesthetic care unit (PACU), where an anesthetist and a nurse unaware of study protocol observed the patients.
The patients were transferred to ward after achieving standard discharge criteria. The duration of sensory block was defined by noting the time when there was return of dull sensation to pinprick, and duration of motor block was defined as time interval between cessation of movement in the limb until patient is able to flex the elbow Bromage (1).
Pain scores were evaluated by a blinded observer anesthesiologist at the time of arrival in PACU and at 2, 4, 6, 12, 18, and 24 h thereafter using visual analog scale (VAS) measurement (5); patients were previously informed about VAS. VAS consists of line with the endpoints defining extreme limits such as “no pain at all” and “pain as bad as it could.” The patient is asked to mark his pain level on the line between the two endpoints (ranging 0–10 cm, where 0 = no pain, 10 = worst pain) (Bird and Dickson 2001). The postoperative analgesic strategy depends on the prescribed oral analgesic (1 g paracetamol/8 h) and rescue analgesia in the form of morphine (2.5 mg was intravenously administered only at VAS (6)).
Postoperative nausea and vomiting (PONV) during the first 24 h were also recorded. PONV was treated with 0.1 mg/kg IV ondansetron. Patient satisfaction was checked after 24 h using five-point Likert scale in the ward by an anesthetist blind to the study, where l = excellent, 2 = very good, 3 = good, 4 = fair, and 5 = poor (Heiberger and Robbins 2014).
Postoperatively (first 24 h), sleep disturbance was evaluated using the Pittsburgh sleep questionnaire (Aloba et al. 2007).
The Pittsburgh Sleep Quality Index is a standardized self-administered questionnaire for the assessment of subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) is the most commonly used retrospective self-report questionnaire that measures sleep quality over the previous month and used as screening for sleep disturbances. We asked patients or one of his close relatives through phone at 24 h postoperatively and every week for the first month after the operation (Table 1).
The PSQI examines seven components of sleep quality retrospectively over a period of 4 weeks: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Scoring of answers is based on a 0–3 scale, whereby “3” reflects the negative extreme. The global score is generated by summing up all seven component scores and ranges from 0 to 21, with higher values corresponding to reduced sleep quality (Fig. 1).
Using the STATA program, alpha error at 5% and power at 80% were set. The result from previous study (Vincent et al. 2001) show that nausea and vomiting were present in 62% of cases in the GA group compared to 18% in the axillary group. Based on this condition, the needed sample is 20 cases per group (40 patients).
Recorded data were analyzed using the Statistical Package for Social Sciences (SPSS), for Windows (version 10) (SPSS Inc., Chicago, IL, USA). Quantitative data are presented as mean ± standard deviation (SD), and independent t-test or Mann-Whitney U test was used as a test of significance. Qualitative data were presented as frequencies and percentages. Chi-square (χ2) test was used as a test of significance. A P value ≤ 0.05 was considered significant.
▪ P- value: level of significance
▪ P < 0.05: significant (S)
▪ P < 0.01: highly significant (HS)
▪ P > 0.05: non-significant (NS)