A Comparative Study Between Ultrasound Guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries: Double Blinded Randomized Clinical Trial
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05982951 |
Recruitment Status :
Active, not recruiting
First Posted : August 9, 2023
Last Update Posted : May 14, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Efficacy of PENG Block Managing Perioperative Pain With Shoulder Arthroscopy Surgeries Efficacy of Shoulder Block in Managing Perioperative Pain With Shoulder Arthroscopy Surgeries | Procedure: Shoulder PENG block | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
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 . |
Primary Purpose: | Treatment |
Official Title: | A Comparative Study Between Ultrasound-guided Shoulder Block and Pericapsular Nerve Group Bock for Shoulder Arthroscopic Surgeries. |
Actual Study Start Date : | January 1, 2024 |
Estimated Primary Completion Date : | August 1, 2024 |
Estimated Study Completion Date : | August 5, 2024 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Shoulder PENG block group
Ultrasound-guided peri-capsular nerve block of the shoulder with 20ml of 0.25% bupivacaine between the supraspinatus muscle and deltoid muscle.
|
Procedure: Shoulder 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
Other Name: Shoulder Block |
Active Comparator: Shoulder block
ultrasound guided axillary nerve block and suprascapular nerve block posterior approach with 10 ml 0.25% bupivacaine (total 20ml)
|
Procedure: Shoulder 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
Other Name: Shoulder Block |
- 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.
- Total morphine consumption milligrams [ Time Frame: 24 hours after surgery ]Total morphine consumption in 24 hours postoperatively.
- Total fentanyl consumptions microgram [ Time Frame: Intraoperative period ]Total fentanyl consumptions as a rescue analgesia intaoperatively
- intraoperative hemodynamics [ Time Frame: Intraoperative period ]Mean arterial blood pressure millimeter mercury , mean heart rate beat per minute
- length of stay in hospital hours [ Time Frame: 24 hours postoperative ]length of stay in hospital after surgery by hours
- postoperative sedation [ Time Frame: Immediate postoperative period ]Ramsey sedation Score
- patient satisfaction [ Time Frame: 24 hours postoperative ]numerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied)
- postoperative nausea and vomiting (PONV) [ Time Frame: 24 hours postoperative ]four points numerical score (0=no PONV, 1= mild nausea , 2= severe nausea or vomiting once, 3= vomiting more than once)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05982951
Egypt | |
Ahmed Maher Teaching Hospital | |
Cairo, Egypt, 11617 |
Other Publications:
Responsible Party: | Kareem Mikhamer, Fellow lecturer of Anaesthesia, General Committee of Teaching Hospitals and Institutes, Egypt |
ClinicalTrials.gov Identifier: | NCT05982951 |
Other Study ID Numbers: |
GeneralCTHI |
First Posted: | August 9, 2023 Key Record Dates |
Last Update Posted: | May 14, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |