PreoperativeNCT06790732
Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
A study testing Saline and Bupivacaine + Dexamethasone in people with Preoperative and Ultrasound-Guided, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the analgesic efficacy of preoperative ultrasound-guided peri-capsular nerve group block (PENG) on postoperative analgesia after shoulder arthroscopic surgery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Preoperative, Ultrasound-Guided, PeriCapsular Nerve Group Block
- What is being tested?
- Saline and Bupivacaine + Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 May 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for unilateral shoulder arthroscopic surgery.
Who cannot join
- Patient refusal.
- Known hypersensitivity to local anesthetics.
- Body mass index> 35 kg /m2.
- Uncooperative or psychiatric patients.
- Infection at the injection site.
- Coagulation disorder.
- Major cardiac, renal, or hepatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
This study aimed to evaluate the analgesic efficacy of preoperative ultrasound-guided peri-capsular nerve group block (PENG) on postoperative analgesia after shoulder arthroscopic surgery.
Read the detailed description
Postoperative pain control after shoulder surgery is challenging, and poor pain management is invariably reflected in poor outcomes, with longer hospitalization and recovery time. The difficulty in reducing pain due to the complexity of shoulder innervation leads to conducting studies to explore selective axillary nerve blocks with a posterior approach or from the axillae.
The peri-capsular nerve group (PENG) block is a regional anesthetic technique. It can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. It targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for better physical therapy, and earlier discharge.
- Conditions
- Preoperative, Ultrasound-Guided, PeriCapsular Nerve Group Block, Postoperative Analgesia, Shoulder Arthroscopic Surgery
- Being tested
- Saline, Bupivacaine + Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Patients received sham PENG block (just 1mL saline).
Bupivacaine + DexamethasoneDrug
Also called PeriCapsular Nerve Group Block (PENG)
Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Patients received sham PENG block (just 1mL saline). Receives: Drug: Saline |
| PeriCapsular Nerve Group Block (PENG) Group | Experimental | Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone). Receives: Drug: Bupivacaine + Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first request of rescue analgesia
Time to the first request of rescue analgesia was recorded from the end of the surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Secondary outcomes (2)
Degree of pain
The degree of pain was assessed using the Numerical Rating Scale (NRS) Pain score (metric score from 0 to 10 where 0 = no pain and 10 = maximal pain). NRS was recorded at PACU and 2, 4, 6, 8, 12, 16, 20, and 24 h postoperative.
Measured: 24 hours postoperatively
Total morphine consumption
If patient numeric rating score was more than 3, patients received 3 mg morphine slowly intravenously. Morphine injection was repeated whenever required.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoperativeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Ayman Khattab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790732
- Sponsor's protocol ID
- 36264MS117/3/23
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Ultrasound-Guided Peri- Capsular Nerve Group Block on Postoperative Analgesia After Shoulder Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT06790732
- Acronym / sponsor ID
- 36264MS117/3/23
- Conditions
- Preoperative, Ultrasound-Guided, PeriCapsular Nerve Group Block, Postoperative Analgesia, Shoulder Arthroscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 24 Jan 2025 (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.
This study aimed to evaluate the analgesic efficacy of preoperative ultrasound-guided peri-capsular nerve group block (PENG) on postoperative analgesia after shoulder arthroscopic surgery.
Detailed description
Postoperative pain control after shoulder surgery is challenging, and poor pain management is invariably reflected in poor outcomes, with longer hospitalization and recovery time. The difficulty in reducing pain due to the complexity of shoulder innervation leads to conducting studies to explore selective axillary nerve blocks with a posterior approach or from the axillae.
The peri-capsular nerve group (PENG) block is a regional anesthetic technique. It can be effectively and safely applied under ultrasound guidance in shoulder surgery cases for postoperative analgesia. It targets only the sensory branches and not the posterior mechanoreceptors; there is a potential motor-sparing effect which is desirable for better physical therapy, and earlier discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Drug: SalinePatients received sham PENG block (just 1mL saline). |
| PeriCapsular Nerve Group Block (PENG) Group | Experimental | Drug: Bupivacaine + DexamethasonePatients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 21 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for unilateral shoulder arthroscopic surgery.
Key exclusion criteria (7 listed)
- Patient refusal.
- Known hypersensitivity to local anesthetics.
- Body mass index> 35 kg /m2.
- Uncooperative or psychiatric patients.
- Infection 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 |
|---|---|---|
| SalinePatients received sham PENG block (just 1mL saline). | Drug | Control Group |
| Bupivacaine + DexamethasoneAlso: PeriCapsular Nerve Group Block (PENG)Patients received real PENG block (15 mL of bupivacaine 0.25% +0.2mg/mL dexamethasone). | Drug | PeriCapsular Nerve Group Block (PENG) Group |
Primary outcome
Time to the first request of rescue analgesia
Time frame: 24 hours postoperatively
Time to the first request of rescue analgesia was recorded from the end of the surgery till first dose of morphine administrated.
2 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
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 24 Jan 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Preoperative
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Recruiting
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
Prostate Cancer (Diagnosis), ACP3
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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 Saline and Bupivacaine + Dexamethasone in people with Preoperative and Ultrasound-Guided, run by Tanta 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 4 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: finished, as of the sponsor's last update on 24 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
Time to the first request of rescue analgesia (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.