An interventional study of Serratus anterior plane block and PENG block in Shoulder Surgery, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patient's recovery. The aim of this study is to assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either serratus anterior plane block versus PENG block comparing and evaluating the differences between the two techniques.It is hypothesized that PENG block will be comparable to serratus anterior plane block as a promising effective alternative for analgesia for arthroscopic shoulder surgeries with fewer side effects. It is suggested that the PENG block can be safely applied for analgesia.
Multimodal pain management is recommended for early postoperative pain control in arthroscopic shoulder surgery. Regional anesthesia is preferred in shoulder surgery as an effective means of providing anesthesia and postoperative analgesia.Commonly used techniques for shoulder surgery include interscalene brachial plexus (ISB) blocks, continuous ISB (CISB) blocks, suprascapular nerve blocks (SSB), supraclavicular nerve blocks (SCB), local infiltration (LI), and ISB with adjuvants. Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery.Relevant studies have found that ultrasound-guided serratus anterior plane block(SAPB) can achieve good anterior lateral chest wall analgesia by injecting local anesthetics into the anterior saw muscle and blocking the lateral cutaneous branch of intercostal nerve which has a significant analgesic effect.The pericapsular nerve group (PENG) block may be safely applied for both partial anesthesia and analgesia in selected shoulder surgery cases. It did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. PENG block has been studied extensively in hip surgeries but its place in shoulder surgeries is not yet clear. Therefore, this study will be conducted to compare efficacy of ultrasound guided serratus anterior plane block with PENG block for postoperative analgesia in patients undergoing arthroscopic shoulder surgeries.
The aim of this study:
The aim of this study is to assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either serratus anterior plane block versus PENG block comparing and evaluating the differences between the two techniques.
Sample Size Calculation:
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 11.0.4 for windows (2011) with mean VAS score at 6 h postoperative as the primary outcome. Using the results published by Zhu H, et al 2022 with mean VAS score at 6 h postoperative in serratus group was (1.85 ± 0.59 ) Using a two-sided two-sample unequal-variance t-test., sample size of 44 patients is needed to achieve 90% power to detect 30 % difference in at 6 h postoperative. Using a two-sided hypothesis test with a significance level of 0.05. A10% drop out is considered, so a total of 50 patients will be enrolled (25 in each group) in this study
Methods:
The study will be conducted in Mansoura university hospital on Fifty patients who will be scheduled for arthroscopic shoulder surgery under general anesthesia. They will be randomly assigned to two equal groups (PENG group and SAPB group) according to computer-generated table of random numbers using the permuted block randomization method. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes which will be opened only after obtaining the written informed consent. A written informed consent will be obtained from all study subjects after ensuring confidentiality. The study protocol will be explained to all patients after enrollment into the study along with VAS after enrollment into the study. Basic demographic characters including age, sex, and weight will be recorded. In both groups, The PENG and SAPB procedures will be performed in the preoperative room under strict aseptic conditions using 30 ml 0.25% bupivacaine.
Statistical Methods:
The collected data will be coded, processed, and analyzed using Statistical Package for the Social Sciences program (version 22) for Windows. Normality of numerical data distribution will be tested by Shapiro- Wilk test. Continuous data of normal distribution will be presented as mean ± standard deviation and compared with the unpaired student's t test. Nonnormally distributed data will be presented as median (range) and compared with the Mann-Whitney U test. Repeated measures ANOVA will be used for comparisons within the same group. Categorical data will be presented as number (percentage) and compared with the Chi-square test. All data will be considered statistically significant if P value is ≤ 0.05.
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Ultrasound-guided SAPB will be applied while the patient is in the supine position.
Procedure: Serratus anterior plane block
Ultrasound-guided PENG block will be performed under strict aseptic precautions and patient's arm will be placed in external rotation and abducted at 45 degrees
Procedure: PENG block
The latissimus dorsi muscle between the midaxillary line and the posterior axillary line will be located under ultrasound guidance. The needle will be inserted into the plane from top to bottom until the serratus anterior surface, and the injectate will be slowly administered.
Ultrasound-guided PENG block will be performed under strict aseptic precautions and patient's arm will be placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, the needle will be inserted using the "in plane" technique. When the needle will have passed through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed Between the deltoid muscle and subscapularis tendon, and the injectate will be slowly administered.
Visual analogue score (VAS) for pain assessment at 6 hour postoperative
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed 6 hour after the procedure.
Time frame: at 6 hour after the procedure
First analgesic request
The time of the first analgesic request for fentanyl will be recorded.
Time frame: Up to 24 hours after the procedure
Total analgesic requirements of fentanyl
The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 24 hours.
Time frame: Up to 24 hours after the procedure
Visual analogue score (VAS) for pain assessment
VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed at 2,4,8,10,12,14,16,18,20,22,24 hour after the procedure.
Time frame: Up to 24 hours after the procedure
Heart rate (HR)
HR will be recorded every 30min till the end of the procedure.
Time frame: During the procedure
Mean arterial blood pressure (MAP)
MAP will be recorded every 30min till the end of the procedure.
Time frame: During the procedure
Adverse effects
Pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded
Time frame: Up to 24 hours after the procedure
Plan to share: No
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Mansoura University