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A Comparative Study Between Ultrasound Guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries: Double Blinded Randomized Clinical Trial

A Comparative Study Between Ultrasound-guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05982951
Enrollment
50
Registered
2023-08-09
Start date
2024-01-01
Completion date
2024-08-05
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries, Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries

Brief 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 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.

Interventions

PROCEDUREShoulder PENG 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

Sponsors

General Committee of Teaching Hospitals and Institutes, Egypt
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The block will be performed by one investigator who is not participating in either data collection or analysis. Also the patient will be blinded .

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* ASA I - II * Age between 18 - 60 * unilateral elective shoulder arthroscopic surgery

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Duration of analgesia (time to first rescue analgesia) minutes24 hours after surgeryPostoperative 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.

Secondary

MeasureTime frameDescription
Total fentanyl consumptions microgramIntraoperative periodTotal fentanyl consumptions as a rescue analgesia intaoperatively
intraoperative hemodynamicsIntraoperative periodMean arterial blood pressure millimeter mercury , mean heart rate beat per minute
length of stay in hospital hours24 hours postoperativelength of stay in hospital after surgery by hours
Total morphine consumption milligrams24 hours after surgeryTotal morphine consumption in 24 hours postoperatively.
patient satisfaction24 hours postoperativenumerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied)
postoperative nausea and vomiting (PONV)24 hours postoperativefour points numerical score (0=no PONV, 1= mild nausea , 2= severe nausea or vomiting once, 3= vomiting more than once)
postoperative sedationImmediate postoperative periodRamsey sedation Score

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026