Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy SurgeriesNCT05982951
A Comparative Study Between Ultrasound Guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries: Double Blinded Randomized Clinical Trial
A study testing Shoulder PENG block in people with Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries and Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
Shoulder arthroscopic surgeries are one of the most common procedures performed daily in our practice. The arthroscopic techniques offer a less invasive option as Open repair does not offer a significantly better 2-year result in terms of stability, and furthermore, can negatively affect the recovery of the full range… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries, Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries
- What is being tested?
- Shoulder PENG block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 5 Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I - II
- Age between 18 - 60
- unilateral elective shoulder arthroscopic surgery
Who cannot join
- Patient refusal
- Altered mental status or un-cooperative patients
- Hypersensitivity to local anesthetics
- Bleeding disorders
- receiving antiplatelet or anticoagulant drugs
- local infection at the site of local injection
- Intra articular infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Ultrasound-guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries.
Shoulder arthroscopic surgeries are one of the most common procedures performed daily in our practice. The arthroscopic techniques offer a less invasive option as Open repair does not offer a significantly better 2-year result in terms of stability, and furthermore, can negatively affect the recovery of the full range of motion of the shoulder. Open techniques Shoulder procedures are performed arthroscopically nowadays with fewer complications compared with open surgery.
Indications of shoulder arthroscopy are expanding and include biceps tears, labral tears, rotator muscle tears, subacromial impingements chondral injuries, loose bodies, early degenerative changes, adhesive capsulitis, shoulder instability and acromioclavicular osteoarthritis.
Read more
There are many regional anesthetic techniques used to control perioperative pain during arthroscopic procedures. Interscalene block results in effective shoulder surgery analgesia, but it is associated with various complications such as diaphragmatic paralysis due to the high incidence of phrenic nerve block.
The suprascapular nerve block combined with the axillary nerve block is non-inferior to conventional inter-scalene block except for the early recovery period with the advantage of lower incidence of dyspnea and discomfort.
. In a cadaveric anatomical study that the posterosuperior quadrant and the posteroinferior quadrant of the GHJ were innervated by the suprascapular nerve and the axillary nerve respectively. While the anterosuperior quadrant portion of the joint is sensory supplied by the subscapularis superior branch and the anteroinferior by the main branch of the axillary nerve. These anatomical data the possibility of a new block targeting the GHJ sensory branches. It was suggested that deep pericapsular infiltration of local anesthetic towards the subscapularis may cover the axillary and subscapularis branches that feed the anteroinferior and superior quadrants of the GHJ.
Recently, the pericapsular nerve group block of the shoulder joint as described in a case series including two cases underwent a humeral neck fracture fixation and Bankart arthroscopic repair with promising anesthesia and analgesia in selected shoulder surgeries.
Read the detailed description
anesthetics Bleeding disorders receiving antiplatelet or anticoagulant drugs local infection at the site of local injection Intra articular infections
Sample size and methodology:
We will enroll 42 patients undergoing elective shoulder arthroscopy. They will be randomized and allocated into two groups; Group A and Group B. Group A will receive an ultrasound-guided PENG block and Group B will receive a shoulder block Sample size justification The 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 (8) with the mean time to first analgesic request in the shoulder block group was (5.9 ± 1.2 hours) Using a two-sided two-sample unequal-variance t-test, a sample size of 42 patients is needed to achieve 95% power to detect 20 % difference in time to a first analgesic request by using a two-sided hypothesis test with a significance level of 0.05.
Anticipated Results The application of pericapsular nerve group block in patients undergoing elective shoulder arthroscopic surgeries may improve the management of their perioperative pain.
Randomization:
The study subjects will be randomized by using block randomization using sealed concealed envelopes into two groups.
Data collection:
The patients will be observed for 24 hours postoperatively by a blinded investigator for the given block. All patients will receive one gram of acetaminophen intravenously every 8 hours as a part of the multimodal analgesia protocol.
The primary outcome will be the duration of analgesia (time to first rescue analgesia after administration of the block). Postoperative pain will be assessed using a 100 mm vertical visual analog score (VAS). The pain score will be recorded at 0, 1, 4, 8, 12, and 24 hours at rest (VASr) and movement (VASm). Morphine will be given intravenously if VASr, VASm, or both exceed 30mm in one milligram allequate with 5 minutes intervals till VAS is less than 30 mm or exceeds the safety dose of 30 mg in 4 hours.
Secondary outcomes:
Total fentanyl consumption as a rescue analgesia intraoperatively. Total morphine consumption in 24 hours postoperatively. Intraoperative hemodynamics mean arterial pressure and mean heart rate. length of stay in hospital Ability to perform physical rehabilitation program in the first 24 hours postoperatively.
postoperative sedation score using the Ramsey score patient satisfaction will be assessed by numerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied) postoperative nausea and vomiting (PONV) will be assessed using a 4 points numerical score (0=no PONV, 1= mild nausea, 2= severe nausea or vomiting once, 3= vomiting more than once)
Endpoint:
The observation of patients will be finished 24 hours postoperatively.
Results:
It will be recorded and analyzed statistically.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder PENG blockProcedure or surgery
Also called Shoulder Block
Ultrasound guided insertion of a needle between subscapularis tendon and deltoid with injection of 10 mi 0.25% bupivacaine after confirming right plane of injection
| Study group | Role | What they receive |
|---|---|---|
| Shoulder PENG block group | Active comparator | Ultrasound-guided peri-capsular nerve block of the shoulder with 20ml of 0.25% bupivacaine between the supraspinatus muscle and deltoid muscle. Receives: Procedure: Shoulder PENG block |
| Shoulder block | Active comparator | ultrasound guided axillary nerve block and suprascapular nerve block posterior approach with 10 ml 0.25% bupivacaine (total 20ml) Receives: Procedure: Shoulder PENG block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia (time to first rescue analgesia) minutes
Postoperative pain will be assessed using 100 millimeter vertical visual analog score (VAS) where (1-3) no pain, >3- 6) mild pain, and (>6 severe pain). The pain score will be recorded at 0, 1, 4, 8, 12, and 24 hours at rest (VASr) and movement (VASm). Morphine will be given intravenously if VASr, VASm, or both exceed 30mm in one milligram adequate with 5 minutes intervals till VAS be less than 30 mm or exceeds the safety dose of 30 mg in 4 hours.
Measured: 24 hours after surgery
Secondary outcomes (7)
Total morphine consumption milligrams
Total morphine consumption in 24 hours postoperatively.
Measured: 24 hours after surgery
Total fentanyl consumptions microgram
Total fentanyl consumptions as a rescue analgesia intaoperatively
Measured: Intraoperative period
intraoperative hemodynamics
Mean arterial blood pressure millimeter mercury , mean heart rate beat per minute
Measured: Intraoperative period
length of stay in hospital hours
length of stay in hospital after surgery by hours
Measured: 24 hours postoperative
postoperative sedation
Ramsey sedation Score
Measured: Immediate postoperative period
patient satisfaction
numerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied)
Measured: 24 hours postoperative
postoperative nausea and vomiting (PONV)
four points numerical score (0=no PONV, 1= mild nausea , 2= severe nausea or vomiting once, 3= vomiting more than once)
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Aug 2024 (estimated)
- Study completion5 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy SurgeriesStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kareem Mikhamer, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982951
- Sponsor's protocol ID
- GeneralCTHI
- Status last verified
- May 2024
- First submitted
- 28 Jul 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rockwood CA Jr. Shoulder arthroscopy. J Bone Joint Surg Am. 1988 Jun;70(5):639-40. No abstract available.
PubMed 3392055Severud EL, Ruotolo C, Abbott DD, Nottage WM. All-arthroscopic versus mini-open rotator cuff repair: A long-term retrospective outcome comparison. Arthroscopy. 2003 Mar;19(3):234-8. doi: 10.1053/jars.2003.50036.
PubMed 12627146Farmer KW, Wright TW. Shoulder arthroscopy: the basics. J Hand Surg Am. 2015 Apr;40(4):817-21. doi: 10.1016/j.jhsa.2015.01.002. Epub 2015 Feb 26.
PubMed 25726045Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
PubMed 27941477Neuts A, Stessel B, Wouters PF, Dierickx C, Cools W, Ory JP, Dubois J, Jamaer L, Arijs I, Schoorens D. Selective Suprascapular and Axillary Nerve Block Versus Interscalene Plexus Block for Pain Control After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Parallel-Controlled Clinical Trial. Reg Anesth Pain Med. 2018 Oct;43(7):738-744. doi: 10.1097/AAP.0000000000000777.
PubMed 29659438Tran J, Peng PWH, Agur AMR. Anatomical study of the innervation of glenohumeral and acromioclavicular joint capsules: implications for image-guided intervention. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100152. doi: 10.1136/rapm-2018-100152. Online ahead of print.
PubMed 30635516Kupeli 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 31142882Grosh T, Elkassabany NM. Enhanced Recovery After Shoulder Arthroplasty. Anesthesiol Clin. 2018 Sep;36(3):417-430. doi: 10.1016/j.anclin.2018.04.006.
PubMed 30092938
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound-guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries.
- ClinicalTrials.gov ID
- NCT05982951
- Acronym / sponsor ID
- GeneralCTHI
- Conditions
- Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries, Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 5 Aug 2024 (estimated)
- First posted
- 9 Aug 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.
Shoulder arthroscopic surgeries are one of the most common procedures performed daily in our practice. The arthroscopic techniques offer a less invasive option as Open repair does not offer a significantly better 2-year result in terms of stability, and furthermore, can negatively affect the recovery of the full range of motion of the shoulder. Open techniques Shoulder procedures are performed arthroscopically nowadays with fewer complications compared with open surgery.
Indications of shoulder arthroscopy are expanding and include biceps tears, labral tears, rotator muscle tears, subacromial impingements chondral injuries, loose bodies, early degenerative changes, adhesive capsulitis, shoulder instability and acromioclavicular osteoarthritis.
There are many regional anesthetic techniques used to control perioperative pain during arthroscopic procedures. Interscalene block results in effective shoulder surgery analgesia, but it is associated with various complications such as diaphragmatic paralysis due to the high incidence of phrenic nerve block.
The suprascapular nerve block combined with the axillary nerve block is non-inferior to conventional inter-scalene block except for the early recovery period with the advantage of lower incidence of dyspnea and discomfort.
. In a cadaveric anatomical study that the posterosuperior quadrant and the posteroinferior quadrant of the GHJ were innervated by the suprascapular nerve and the axillary nerve respectively. While the anterosuperior quadrant portion of the joint is sensory supplied by the subscapularis superior branch and the anteroinferior by the main branch of the axillary nerve. These anatomical data the possibility of a new block targeting the GHJ sensory branches. It was suggested that deep pericapsular infiltration of local anesthetic towards the subscapularis may cover the axillary and subscapularis branches that feed the anteroinferior and superior quadrants of the GHJ.
Recently, the pericapsular nerve group block of the shoulder joint as described in a case series including two cases underwent a humeral neck fracture fixation and Bankart arthroscopic repair with promising anesthesia and analgesia in selected shoulder surgeries.
Detailed description
anesthetics Bleeding disorders receiving antiplatelet or anticoagulant drugs local infection at the site of local injection Intra articular infections
Sample size and methodology:
We will enroll 42 patients undergoing elective shoulder arthroscopy. They will be randomized and allocated into two groups; Group A and Group B. Group A will receive an ultrasound-guided PENG block and Group B will receive a shoulder block Sample size justification The 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 (8) with the mean time to first analgesic request in the shoulder block group was (5.9 ± 1.2 hours) Using a two-sided two-sample unequal-variance t-test, a sample size of 42 patients is needed to achieve 95% power to detect 20 % difference in time to a first analgesic request by using a two-sided hypothesis test with a significance level of 0.05.
Anticipated Results The application of pericapsular nerve group block in patients undergoing elective shoulder arthroscopic surgeries may improve the management of their perioperative pain.
Randomization:
The study subjects will be randomized by using block randomization using sealed concealed envelopes into two groups.
Data collection:
The patients will be observed for 24 hours postoperatively by a blinded investigator for the given block. All patients will receive one gram of acetaminophen intravenously every 8 hours as a part of the multimodal analgesia protocol.
The primary outcome will be the duration of analgesia (time to first rescue analgesia after administration of the block). Postoperative pain will be assessed using a 100 mm vertical visual analog score (VAS). The pain score will be recorded at 0, 1, 4, 8, 12, and 24 hours at rest (VASr) and movement (VASm). Morphine will be given intravenously if VASr, VASm, or both exceed 30mm in one milligram allequate with 5 minutes intervals till VAS is less than 30 mm or exceeds the safety dose of 30 mg in 4 hours.
Secondary outcomes:
Total fentanyl consumption as a rescue analgesia intraoperatively. Total morphine consumption in 24 hours postoperatively. Intraoperative hemodynamics mean arterial pressure and mean heart rate. length of stay in hospital Ability to perform physical rehabilitation program in the first 24 hours postoperatively.
postoperative sedation score using the Ramsey score patient satisfaction will be assessed by numerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied) postoperative nausea and vomiting (PONV) will be assessed using a 4 points numerical score (0=no PONV, 1= mild nausea, 2= severe nausea or vomiting once, 3= vomiting more than once)
Endpoint:
The observation of patients will be finished 24 hours postoperatively.
Results:
It will be recorded and analyzed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder PENG block group | Active comparator | Procedure: Shoulder PENG blockUltrasound-guided peri-capsular nerve block of the shoulder with 20ml of 0.25% bupivacaine between the supraspinatus muscle and deltoid muscle. |
| Shoulder block | Active comparator | Procedure: Shoulder PENG blockultrasound guided axillary nerve block and suprascapular nerve block posterior approach with 10 ml 0.25% bupivacaine (total 20ml) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I - II
- Age between 18 - 60
- unilateral elective shoulder arthroscopic surgery
Key exclusion criteria (7 listed)
- Patient refusal
- Altered mental status or un-cooperative patients
- Hypersensitivity to local anesthetics
- Bleeding disorders
- receiving antiplatelet or anticoagulant drugs
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 |
|---|---|---|
| Shoulder PENG blockAlso: Shoulder BlockUltrasound guided insertion of a needle between subscapularis tendon and deltoid with injection of 10 mi 0.25% bupivacaine after confirming right plane of injection | Procedure or surgery | Shoulder PENG block group, Shoulder block |
Primary outcome
Duration of analgesia (time to first rescue analgesia) minutes
Time frame: 24 hours after surgery
Postoperative pain will be assessed using 100 millimeter vertical visual analog score (VAS) where (1-3) no pain, >3- 6) mild pain, and (>6 severe pain). The pain score will be recorded at 0, 1, 4, 8, 12, and 24 hours at rest (VASr) and movement (VASm). Morphine will be given intravenously if VASr, VASm, or both exceed 30mm in one milligram adequate with 5 minutes intervals till VAS be less than 30 mm or exceeds the safety dose of 30 mg in 4 hours.
7 secondary outcomes
Total morphine consumption milligrams
Time frame: 24 hours after surgery
Total fentanyl consumptions microgram
Time frame: Intraoperative period
intraoperative hemodynamics
Time frame: Intraoperative period
length of stay in hospital hours
Time frame: 24 hours postoperative
postoperative sedation
Time frame: Immediate postoperative period
patient satisfaction
Time frame: 24 hours postoperative
postoperative nausea and vomiting (PONV)
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 3392055Rockwood CA Jr. Shoulder arthroscopy. J Bone Joint Surg Am. 1988 Jun;70(5):639-40. No abstract available.
- Background: PubMed 12627146Severud EL, Ruotolo C, Abbott DD, Nottage WM. All-arthroscopic versus mini-open rotator cuff repair: A long-term retrospective outcome comparison. Arthroscopy. 2003 Mar;19(3):234-8. doi: 10.1053/jars.2003.50036.
- Background: PubMed 25726045Farmer KW, Wright TW. Shoulder arthroscopy: the basics. J Hand Surg Am. 2015 Apr;40(4):817-21. doi: 10.1016/j.jhsa.2015.01.002. Epub 2015 Feb 26.
- Background: PubMed 27941477Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
- Background: PubMed 29659438Neuts A, Stessel B, Wouters PF, Dierickx C, Cools W, Ory JP, Dubois J, Jamaer L, Arijs I, Schoorens D. Selective Suprascapular and Axillary Nerve Block Versus Interscalene Plexus Block for Pain Control After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Parallel-Controlled Clinical Trial. Reg Anesth Pain Med. 2018 Oct;43(7):738-744. doi: 10.1097/AAP.0000000000000777.
- Background: PubMed 30635516Tran J, Peng PWH, Agur AMR. Anatomical study of the innervation of glenohumeral and acromioclavicular joint capsules: implications for image-guided intervention. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100152. doi: 10.1136/rapm-2018-100152. Online ahead of print.
- Background: 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.
- Background: 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 30092938Grosh T, Elkassabany NM. Enhanced Recovery After Shoulder Arthroplasty. Anesthesiol Clin. 2018 Sep;36(3):417-430. doi: 10.1016/j.anclin.2018.04.006.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder PENG block in people with Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries and Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries, run by General Committee of Teaching Hospitals and Institutes, Egypt 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 May 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?
Results are not available in the source record.
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?
Duration of analgesia (time to first rescue analgesia) minutes (time frame: 24 hours after surgery). 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 NCT05982951, which also lists 9 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 14 May 2024.