Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772533
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2023-03-06
Brief Title:
Serratus Anterior Plane Block Versus Pericapsular Nerve Group Block for Shoulder Surgery
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Ultrasound-guided Serratus Anterior Plane Block Versus Pericapsular Nerve Group Block PENG for Postoperative Analgesia in in Arthroscopic Shoulder Surgery a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patients 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 techniquesIt 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
Detailed Description:
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 analgesiaCommonly 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 surgeryRelevant studies have found that ultrasound-guided serratus anterior plane blockSAPB 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 effectThe 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 1104 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 185 059 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 005 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 025 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 students 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 005
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 1104 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 185 059 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 005 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 025 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 students 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None