Shoulder SurgeryNCT05755802
Shoulder Block Versus Pericapsular Nerve Group Block for Shoulder Surgery
A study testing PENG block and Shoulder block in people with Shoulder Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
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 shoulder block versus PENG block comparing and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- PENG block and Shoulder block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2023to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) 1 or 2 patients.
- Scheduled for elective unilateral shoulder arthroscopy.
Who cannot join
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection or redness at the injection site.
- Significant cardiac dysfunction, hepatic, or renal impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Shoulder Block Versus Pericapsular Nerve Group Block (PENG) for Postoperative Analgesia in Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
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 shoulder block versus PENG block comparing and evaluating the differences between the two techniques.It is hypothesized that PENG block will be comparable to shoulder 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.
Read the detailed description
Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patient's recovery. Multimodal pain management is recommended for early postoperative pain control. 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. Shoulder block which is combination of suprascapular nerve block and axillary nerve block has been recently proposed as an alternative anesthetic and postoperative analgesic modality in this patient population. These two nerve blocks cause the loss of the sensory innervation of the shoulder. Shoulder block is advantageous to the interscalene brachial plexus block since it does not lead to respiratory dysfunction due to phrenic nerve palsy or other serious complications.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 shoulder block with PENG block for postoperative analgesia in patients undergoing arthroscopic shoulder surgeries.
The aim of this study:
assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either shoulder 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 time to first analgesic request as the primary outcome. Using the results published by Pani et al 2019 with the mean time to first analgesic request in shoulder block group was (5.9 ± 1.2 hours) Using a two-sided two-sample unequal-variance t-test, sample size of 40 patients is needed to achieve 90% power to detect 20 % difference in time to first analgesic request. Using a two-sided hypothesis test with a significance level of 0.05. A 10% drop out is considered, so a total of 46 patients will be enrolled (23 in each group) in this study.
Methods:
The study will be conducted in Mansoura university hospital on Forty six patients who will be scheduled for arthroscopic shoulder surgery under general anesthesia. They will be randomly assigned to two equal groups (PENG group and shoulder block 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 shoulder block procedures will be performed in the preoperative regional room under strict aseptic conditions using 30 ml 0.25% bupivacaine.
Statistical Methods:
The collected data will be coded, processed, and analyzed using SPSS(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 ± SD(standard deviation) and compared with the unpaired student's t test. Non-normally 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.
- Conditions
- Shoulder Surgery
- Being tested
- PENG block, Shoulder block
- Keywords
- Pericapsular nerve group block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG blockProcedure or surgery
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.
Shoulder blockProcedure or surgery
The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it Will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. A 50 mm nerve block needle will be used in the long axis view for the block. After confirming extravascular placement of the needle, injectate will be given below the supraspinatus fascia and then during axillary nerve block,The posterior surface of the humerus will be visualised in the short axis view. So, the circumflex artery will be visualised longitudinally. After confirming extra-vascular placement of the needle, injectate will be given into space.
| Study group | Role | What they receive |
|---|---|---|
| Group A (PENG block) | Active comparator | 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. Receives: Procedure: PENG block |
| Group B (Shoulder block) | Active comparator | Ultrasound-guided shoulder block will be performed under strict aseptic precautions with patient in semi-recumbent position with the operating arm on the contra-lateral shoulder.and then, the patients will be positioned in a semi-recumbent position with the arm slightly flexed and adducted at the elbow for axillary nerve block. Receives: Procedure: Shoulder block |
What is being measured
The primary outcome is the main question the study is designed to answer.
First analgesic request
The time of the first analgesic request for fentanyl will be recorded.
Measured: Up to 24 hours after the procedure
Secondary outcomes (5)
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 every two hours for 24 hours after the procedure.
Measured: 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.
Measured: Up to 24 hours after the procedure
Heart rate (HR)
HR will be recorded every 30min till the end of the procedure.
Measured: During the procedure
Mean arterial blood pressure (MAP)
MAP will be recorded every 30min till the end of the procedure.
Measured: During the procedure
Adverse effects
Pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded.
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start5 Jun 2023
- Primary completion5 Feb 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hazem abdelmaksood EL-deeb, Mansoura University
- Investigators
- Amany H EL-Deeb, MD, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755802
- Sponsor's protocol ID
- PENGB for shoulder surgery
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casas Reza P, Dieguez Garcia P, Gestal Vazquez M, Sampayo Rodriguez L, Lopez Alvarez S. Pericapsular nerve group block for hip surgery. Minerva Anestesiol. 2020 Apr;86(4):463-465. doi: 10.23736/S0375-9393.20.14166-X. Epub 2020 Jan 28. No abstract available.
PubMed 32000476van Erp JHJ, Ostendorf M, Lansdaal JR. Shoulder surgery in beach chair position causing perioperative stroke: Four cases and a review of the literature. J Orthop. 2019 May 27;16(6):493-495. doi: 10.1016/j.jor.2019.05.009. eCollection 2019 Nov-Dec.
PubMed 31680738Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
PubMed 35550031Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
PubMed 34118263Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia for shoulder arthroscopic surgeries: A comparison between inter-scalene block and shoulder block. Indian J Anaesth. 2019 May;63(5):382-387. doi: 10.4103/ija.IJA_65_19.
PubMed 31142882Patel MS, Abboud JA, Sethi PM. Perioperative pain management for shoulder surgery: evolving techniques. J Shoulder Elbow Surg. 2020 Nov;29(11):e416-e433. doi: 10.1016/j.jse.2020.04.049. Epub 2020 Jun 9.
PubMed 32844751Sahin A, Baran O, Cetin MU, Gultekin A, Arar MC. Combined suprascapular nerve block and axillary nerve block approach vs. peri-articular infiltration analgesia for postoperative pain management following arthroscopic shoulder surgery: a randomized clinical trial. Eur Rev Med Pharmacol Sci. 2022 Dec;26(24):9117-9125. doi: 10.26355/eurrev_202212_30661.
PubMed 36591824Sripada R, Bowens C Jr. Regional anesthesia procedures for shoulder and upper arm surgery upper extremity update--2005 to present. Int Anesthesiol Clin. 2012 Winter;50(1):26-46. doi: 10.1097/AIA.0b013e31821a0284.
PubMed 22227421
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Shoulder Block Versus Pericapsular Nerve Group Block (PENG) for Postoperative Analgesia in Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05755802
- Acronym / sponsor ID
- PENGB for shoulder surgery
- Conditions
- Shoulder Surgery
- Keywords
- Pericapsular nerve group block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 shoulder block versus PENG block comparing and evaluating the differences between the two techniques.It is hypothesized that PENG block will be comparable to shoulder 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
Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patient's recovery. Multimodal pain management is recommended for early postoperative pain control. 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. Shoulder block which is combination of suprascapular nerve block and axillary nerve block has been recently proposed as an alternative anesthetic and postoperative analgesic modality in this patient population. These two nerve blocks cause the loss of the sensory innervation of the shoulder. Shoulder block is advantageous to the interscalene brachial plexus block since it does not lead to respiratory dysfunction due to phrenic nerve palsy or other serious complications.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 shoulder block with PENG block for postoperative analgesia in patients undergoing arthroscopic shoulder surgeries.
The aim of this study:
assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either shoulder 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 time to first analgesic request as the primary outcome. Using the results published by Pani et al 2019 with the mean time to first analgesic request in shoulder block group was (5.9 ± 1.2 hours) Using a two-sided two-sample unequal-variance t-test, sample size of 40 patients is needed to achieve 90% power to detect 20 % difference in time to first analgesic request. Using a two-sided hypothesis test with a significance level of 0.05. A 10% drop out is considered, so a total of 46 patients will be enrolled (23 in each group) in this study.
Methods:
The study will be conducted in Mansoura university hospital on Forty six patients who will be scheduled for arthroscopic shoulder surgery under general anesthesia. They will be randomly assigned to two equal groups (PENG group and shoulder block 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 shoulder block procedures will be performed in the preoperative regional room under strict aseptic conditions using 30 ml 0.25% bupivacaine.
Statistical Methods:
The collected data will be coded, processed, and analyzed using SPSS(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 ± SD(standard deviation) and compared with the unpaired student's t test. Non-normally 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blind study
| Arm | Type | Receives |
|---|---|---|
| Group A (PENG block) | Active comparator | Procedure: PENG blockUltrasound-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. |
| Group B (Shoulder block) | Active comparator | Procedure: Shoulder blockUltrasound-guided shoulder block will be performed under strict aseptic precautions with patient in semi-recumbent position with the operating arm on the contra-lateral shoulder.and then, the patients will be positioned in a semi-recumbent position with the arm slightly flexed and adducted at the elbow for axillary nerve block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) 1 or 2 patients.
- Scheduled for elective unilateral shoulder arthroscopy.
Key exclusion criteria (6 listed)
- Patient's refusal.
- Altered mental status or un-cooperative patients.
- History of known sensitivity to the used anesthetics.
- Bleeding or coagulation diathesis.
- Infection or redness at the injection site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG blockA 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. | Procedure or surgery | Group A (PENG block) |
| Shoulder blockThe probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it Will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. A 50 mm nerve block needle will be used in the long axis view for the block. After confirming extravascular placement of the needle, injectate will be given below the supraspinatus fascia and then during axillary nerve block,The posterior surface of the humerus will be visualised in the short axis view. So, the circumflex artery will be visualised longitudinally. After confirming extra-vascular placement of the needle, injectate will be given into space. | Procedure or surgery | Group B (Shoulder block) |
Primary outcome
First analgesic request
Time frame: Up to 24 hours after the procedure
The time of the first analgesic request for fentanyl will be recorded.
5 secondary outcomes
Visual analogue score (VAS) for pain assessment
Time frame: Up to 24 hours after the procedure
Total analgesic requirements of fentanyl
Time frame: Up to 24 hours after the procedure
Heart rate (HR)
Time frame: During the procedure
Mean arterial blood pressure (MAP)
Time frame: During the procedure
Adverse effects
Time frame: Up to 24 hours after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Results publication: PubMed 32000476Casas Reza P, Dieguez Garcia P, Gestal Vazquez M, Sampayo Rodriguez L, Lopez Alvarez S. Pericapsular nerve group block for hip surgery. Minerva Anestesiol. 2020 Apr;86(4):463-465. doi: 10.23736/S0375-9393.20.14166-X. Epub 2020 Jan 28. No abstract available.
- Results publication: PubMed 31680738van Erp JHJ, Ostendorf M, Lansdaal JR. Shoulder surgery in beach chair position causing perioperative stroke: Four cases and a review of the literature. J Orthop. 2019 May 27;16(6):493-495. doi: 10.1016/j.jor.2019.05.009. eCollection 2019 Nov-Dec.
- Results publication: PubMed 35550031Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
- Results publication: PubMed 34118263Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
- Results publication: PubMed 31142882Pani N, Routray SS, Pani S, Mallik S, Pattnaik S, Pradhan A. Post-operative analgesia for shoulder arthroscopic surgeries: A comparison between inter-scalene block and shoulder block. Indian J Anaesth. 2019 May;63(5):382-387. doi: 10.4103/ija.IJA_65_19.
- Results publication: PubMed 32844751Patel MS, Abboud JA, Sethi PM. Perioperative pain management for shoulder surgery: evolving techniques. J Shoulder Elbow Surg. 2020 Nov;29(11):e416-e433. doi: 10.1016/j.jse.2020.04.049. Epub 2020 Jun 9.
- Results publication: PubMed 36591824Sahin A, Baran O, Cetin MU, Gultekin A, Arar MC. Combined suprascapular nerve block and axillary nerve block approach vs. peri-articular infiltration analgesia for postoperative pain management following arthroscopic shoulder surgery: a randomized clinical trial. Eur Rev Med Pharmacol Sci. 2022 Dec;26(24):9117-9125. doi: 10.26355/eurrev_202212_30661.
- Results publication: PubMed 22227421Sripada R, Bowens C Jr. Regional anesthesia procedures for shoulder and upper arm surgery upper extremity update--2005 to present. Int Anesthesiol Clin. 2012 Winter;50(1):26-46. doi: 10.1097/AIA.0b013e31821a0284.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amany H EL-Deeb, MD principal investigator
Faculty of Medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block and Shoulder block in people with Shoulder Surgery, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First analgesic request (time frame: Up to 24 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05755802, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.