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Background:Two open-label, randomized, parallel-arm studies compared pharmacokinetics, safety, and tolerability of aripiprazole once-monthly 400 mg following deltoid vs gluteal injection in patients with schizophrenia.Methods:In the single-dose study, 1 injection of aripiprazole once-monthly 400 mg in the deltoid (n=17) or gluteal (n=18) muscle (NCT01646827) was administered. In the multiple-dose study, the first aripiprazole once-monthly 400 mg injection was administered in either the deltoid (n=71) or gluteal (n=67) muscle followed by 4 once-monthly deltoid injections (NCT01909466).Results:After single-dose administration, aripiprazole exposure (area under the concentration-time curve) was similar between deltoid and gluteal administrations, whereas median time to maximum plasma concentration was shorter (7.1 [deltoid] vs 24.1 days [gluteal]) and maximum concentration was 31% higher after deltoid administration. In the multiple-dose study, median time to maximum plasma concentration for deltoid administration was shorter (3.95 vs 7.1 days), whereas aripiprazole mean trough concentrations, maximum concentration, and area under the concentration-time curve were comparable between deltoid and gluteal muscles (historical data comparison). Multiple-dose pharmacokinetic results for the major metabolite, dehydro-aripiprazole, followed a similar pattern to that of the parent drug for both deltoid and gluteal injection sites. Safety and tolerability profiles were similar after gluteal or deltoid injections. Based on observed data, minimum aripiprazole concentrations achieved by aripiprazole once-monthly 400 mg are comparable with those of oral aripiprazole 15 to 20 mg/d.Conclusions:The deltoid muscle is a safe alternative injection site for aripiprazole once-monthly 400 mg in patients with schizophrenia.

Purpose Shoulder surgeries, vital for diverse pathologies, pose a risk of iatrogenic nerve damage. Existing literature lacks diverse bone landmark–specific nerve position data. The purpose of this study is to address this gap by investigating such relationships. Method This cadaveric study examines axillary, radial and suprascapular nerves’ relation with acromion, coracoid and greater tuberosity of the humerus (GT). It also correlates this data with humeral lengths and explores nerve dynamics in relation to arm positions. Results The mean distance from the axillary nerve to (i) GT was 4.38 cm (range 3.32–5.44, SD 0.53), (ii) acromion was 6.42 cm (range 5.03–7.8, SD 0.694) and (iii) coracoid process was 4.3 cm (range 2.76–5.84, SD 0.769). Abduction brought the nerve closer by 0.36 cm, 0.35 cm and 0.53 cm, respectively. The mean distance from radial nerve to (i) GT was 5.46 cm (range 3.78–7.14, SD 0.839), (ii) acromion was 7.82 cm (range 5.4–10.24, SD 1.21) and (iii) tip of the coracoid process was 6.09 cm (range 4.07–8.11 cm, SD 1.01). The mean distance from the suprascapular nerve to the acromion was 4.2 cm (range 3.1–5.4, SD 0.575). The mean humeral length was noted to be 27.83 cm (range 25.3–30.7, SD 1.13). There was no significant correlation between these distances and humeral lengths. Conclusion It is essential to exercise caution to avoid axillary nerve damage during the abduction manoeuvre, as its distance from the greater tuberosity and tip of the coracoid process has shown a significant reduction. The safe margins, in relation to the length of the humerus and consequently the patient’s stature, exhibit no significant variation. In situations where the greater tuberosity (GT) and the border of the acromion are inaccessible due to reasons such as trauma, the tip of the coracoid process can serve as a dependable bone landmark for establishing a secure surgical margin.

Background The innervation of the shoulder-upper-extremity area is complicated and unclear. Regional anesthesia with a brachial plexus and cervical plexus block is probably inadequate for the proximal humeral surgery. Missing blockade of the T1–T2 nerves may be the reason. We conduct this prospective randomized controlled trial (RCT) to explore whether an additional T2 thoracic paravertebral block (TPVB) can improve the success rate of regional anesthesia for elderly patients in proximal humeral fracture surgery. Methods/design The patients aged 65 years or older, referred for anterior-approach proximal humeral fracture surgery, will be enrolled. Each patient will be randomly assigned 1:1 to receive a combined interscalene brachial plexus with superficial cervical plexus block (IC) (combined interscalene brachial plexus with superficial cervical plexus block) or an IC block combined with thoracic paravertebral block (ICTP) block (combined thoracic paravertebral block with brachial plexus and superficial cervical plexus block). The primary outcome is the success rate of regional anesthesia without rescue analgesic methods. The secondary outcomes are as follows: sensory block at the surgical area, proportion of patients who need rescue anesthesia (intravenously administered remifentanil or conversion to general anesthesia), cumulative doses of intraoperative vasoactive medications and adverse events. The total sample size is estimated to be 80 patients. Discussion This RCT aims to confirm whether an additional T2 TPVB can provide better anesthetic effects of regional anesthesia with brachial and cervical plexus block in elderly patients undergoing proximal humeral surgery. Trial registration ClinicalTrials.gov , ID: NCT03919422 . Registered on 19 April 2019.

Dislocation of the shoulder joint is one of the most common dislocations. The reduction procedure is a painful procedure. In this study, 2 different treatment groups were compared for pain control during shoulder dislocation reduction. It was aimed to evaluate the differences between the groups in reduction, success, length of hospital stay, complications, side effects, patient-physician satisfaction, and ease of application. The study was planned to be prospective and randomized. As procedural sedation analgesia (SA), titration of ketamine 1 to 2 mg/kg was administered intravenously to group 1. Suprascapular nerve block (SNB) was applied under ultrasound guidance (USG) to group 2. Conformity to normal distribution of variables was examined with the Kolmogorov-Smirnov test. The χ2 test and Fisher test were used to evaluate differences between the groups in categorical variables and the Mann-Whitney U test, and a value of P < .05 was accepted as statistically significant. The study comprised a total of 41 patients; 20 in the group 1 and 21 in the group 2. No statistically significant difference was determined between the groups in terms of age (P = .916), sex (P = .972), reduction success (P = .540), and patient-physician satisfaction (P = .198). The time spent in the emergency department (ED) by patients in the SA group was signficantly longer compared with the SNB group. No side effects were observed in the SNB group. Suprascapular nerve block, which can be easily applied under USG in the ED, can be evaluated as a good alternative to SA in the reduction of shoulder dislocations.

Shoulder pain can be difficult to treat due to its complex anatomic structure, and different treatment methods can be used. We aimed to examine the efficacy of photobiomodulation therapy (PBMT) and suprascapular nerve (SSN)-pulsed radiofrequency (RF) therapy. In this prospective, randomized, controlled, single-blind study, 59 patients with chronic shoulder pain due to impingement syndrome received PBMT (group H) or SSN-pulsed RF therapy (group P) in addition to exercise therapy for 14 sessions over 2 weeks. Records were taken using visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), and Nottingham Health Profile (NHP) scoring systems for pretreatment (PRT), posttreatment (PST), and PST follow-up at months 1, 3, and 6. There was no statistically significant difference in initial VAS score, SPADI, and NHP values between group H and group P ( p  > 0.05). Compared to the values of PRT, PST, and PST at months 1, 3, and 6, VAS, SPADI, and NHP values were statistically significantly lower in both groups ( p  < 0.001). There was no statistically significant difference at all measurement times in VAS, SPADI, and NHP between the two groups. We established that PBMT and SSN-pulsed RF therapy are effective methods, in addition to exercise therapy, in patients with chronic shoulder pain. PBMT seems to be advantageous compared to SSN-pulsed RF therapy, as it is a noninvasive method.

Background A classical approach to produce interscalene brachial plexus block (ISBPB) consistently spares the posterior aspect of the shoulder and ulnar sides of the elbow, forearm, and hand, which are innervated by the lower trunk of the brachial plexus (C8–T1). As an alternative to the classical approach, a caudal approach to ISBPB successfully produces anesthesia of the ulnar sides of the elbow, forearm, and hand. However, its beneficial effects on anesthesia in the posterior aspect of the shoulder have not been investigated. In addition, the C8 nerve root is not routinely selectively blocked during ISBPB. Therefore, we will compare the C5 to C7 and C5 to C8 nerve root blocks during a caudal approach to ISBPB to assess the clinical benefit of C8 nerve blocks for the surgical anesthesia of the posterior aspect of the shoulder. Methods/design In this prospective parallel-group single-blind randomized controlled trial, 74 patients scheduled to undergo arthroscopic shoulder surgery under ISBPB are randomly allocated to receive the C5 to C7 or C5 to C8 nerve root block at a 1:1 ratio. The primary outcome is pain intensity, which is rated as 0 (no pain), 1 (mild pain), or 2 (severe pain), during the introduction of a posterior portal into the glenohumeral joint. The secondary outcomes are (1) the extent of the ipsilateral sensory, motor, hemidiaphragmatic, and stellate ganglion blockade, (2) changes in the results of a pulmonary function test, (3) incidence of complications related to ISBPB, (4) postoperative numerical pain rating scale scores, (5) patients’ satisfaction with the ISBPB, (6) dose and frequency of analgesic use, and (7) incidence of conversion to general anesthesia. Discussion This study is the first to evaluate the beneficial effects of the C8 nerve root block during ISBPB, which has rarely been performed due to the technical challenge in visualizing and blocking the C8 nerve root. It is expected that a C8 nerve root block performed during ISBPB will provide sufficient surgical anesthesia of the posterior aspect of the shoulder, which cannot be achieved by a classical approach to ISBPB. Trial registration ClicnicalTrials.gov, NCT03487874 . Registered on 4 April 2018.

Background The sensory innervation of the shoulder is complex and there are variations in the branching patterns of the sensory fibres. Articular branches from the axillary nerve to the subacromial bursa are described in more than 50% of investigated shoulders but the isolated contribution of sensory input from the axillary nerve has never been investigated clinically. We hypothesized that a selective block of the axillary nerve would reduce morphine consumption and pain after arthroscopic subacromial decompression. Methods We included 60 patients in a randomized, blinded, placebo-controlled study. Patients were randomized to a preoperative selective ultrasound-guided axillary nerve block with 20 mL ropivacaine (7.5 mg/mL) or 20 mL saline. Primary outcome was intravenous morphine consumption 0–4 h postoperatively. Secondary outcome was postoperative pain evaluated by a visual analogue scale (VAS) score (0–100). Results We analysed data from 50 patients and found no significant difference in 0–4 h postoperative morphine consumption between the two groups (ropivacaine 14 mg, placebo 18 mg ( P  = 0.12)) . There was a reduction in postoperative pain: VAS 0–4 h (area under the curve) (ropivacaine 135, placebo 182 ( P  = 0.03)), VAS after 8 h (ropivacaine 9, placebo 20 ( P  = 0.01)) and VAS after 24 h (ropivacaine 7, placebo 18 ( P  = 0.04)). Eight out of 19 patients with a successful selective axillary nerve block needed an interscalene brachial plexus escape block. Conclusions Selective block of the axillary nerve has some pain relieving effect, but in this setting the effect was unpredictable, variable and far from sufficient in a large proportion of the patients. Trial registration ClinicalTrials.gov ( NCT01463865 ). Registered: November 1, 2011.

Background There is a growing debate on the relationship between health-related quality of life (HRQoL) and patient survival which has been going on for the last few decades. The greatest wish of clinicians is to extend the latter while improving the former. Following neck dissection of early-stage oral carcinoma, “shoulder syndrome” appears due to traction of the accessory nerve during removal of level IIb, which greatly affects patient quality of life. Since occult metastasis in level IIb of early-stage oral carcinoma is extremely low, some surgeons suggest that level IIb can be exempt from dissection to improve the HRQoL. However, other surgeons take the opposite view, and thus there is no consensus on the necessity of IIb dissection in T1–2N0M0 oral squamous cell carcinoma (OSCC). Methods We designed a parallel-group, randomized, non-inferiority trial that is supported by Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China. We will enroll 522 patients with early oral carcinoma who match the inclusion criteria, and compare differences in 3-year overall survival, progression–free survival (PFS) and HRQoL under different interventions (retention or dissection of level IIb). The primary endpoints will be tested by means of two-sided log-rank tests. Analysis of overall and progression-free survival will be performed in subgroups that were defined according to stratification factors with the use of univariate Cox analysis. In addition, we will use post-hoc subgroup analyses on the basis of histological factors that were known to have effects on survival, such as death of invasion of the primary tumor. To evaluate HRQoL, we will choose the Constant–Murley scale to measure shoulder function. Discussion Currently, there are no randomized controlled trials with large sample sizes on the necessity of IIB dissection in T1–T2N0M0 OSCC. We designed this noninferiority RCT that combines survival rate and HRQoL to assess the feasibility of IIb neck dissection. The result of this trial may guide clinical practice and change the criteria of how early-stage oral cancer is managed. The balance between survival and HRQoL in this trial is based on early-stage breast cancer treatment and may provide new ideas for other malignancies. Trial registration Chinese Clinical Trial Registry, ChiCTR1800019128 . Registered on 26 October 2018.