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

May 12, 2024 updated by: Kareem Mikhamer, General Committee of Teaching Hospitals and Institutes, Egypt

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11617
        • Ahmed Maher Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Shoulder Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption milligrams
Time Frame: 24 hours after surgery
Total morphine consumption in 24 hours postoperatively.
24 hours after surgery
Total fentanyl consumptions microgram
Time Frame: Intraoperative period
Total fentanyl consumptions as a rescue analgesia intaoperatively
Intraoperative period
intraoperative hemodynamics
Time Frame: Intraoperative period
Mean arterial blood pressure millimeter mercury , mean heart rate beat per minute
Intraoperative period
length of stay in hospital hours
Time Frame: 24 hours postoperative
length of stay in hospital after surgery by hours
24 hours postoperative
postoperative sedation
Time Frame: Immediate postoperative period
Ramsey sedation Score
Immediate postoperative period
patient satisfaction
Time Frame: 24 hours postoperative
numerical score (1= very dissatisfied, 2= dissatisfied, 3=neither satisfied or dissatisfied, 4= satisfied, 5=very satisfied)
24 hours postoperative
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)
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 5, 2024

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • GeneralCTHI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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