Effect of Pericapsular Nerve Block on the Quality of Recovery After Shoulder Arthroscopy
1 other identifier
interventional
60
1 country
1
Brief Summary
Shoulder arthroscopy surgery is one of the most common orthopedic surgical procedures. Participants experience severe pain after shoulder arthroscopy surgery. This causes the use of high amounts of opioids, delays healing, causes bleeding in the surgical area, and can cause physiological disorders by increasing the stress response. Multiple studies have been conducted for analgesic purposes in shoulder surgery. Tran et al., posterior to the glenohumeral joint of the superior part of the suprascapular nerve, posterior inferior part of the posterior branch of the axillary nerve, anterior superior part of subscapularis superior branch, anterior claimed that the axillary nerve innervates the inferior part. In their case report, reported that the pericapsular nerve block (PENG) applied to participants undergoing shoulder surgery provided postoperative analgesia for 16-24 hours pericapsuler nerve block, which is generally applied in hip surgeries, can be applied in shoulder surgery, but there is no large-scale study on pericapsuler nerve block in shoulder surgery, and there is still unknown whether there is a relationship between the pericapsuler nerve block to be applied and the quality of postoperative recovery. Recovery after surgery and anesthesia is complex.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedStudy Start
First participant enrolled
January 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedApril 16, 2024
April 1, 2024
3 months
December 9, 2023
April 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
quality of recovery-15T
The primary evaluation criteria will be the recording of Quality of recovery-15 scores, which indicate the quality of recovery of patients before and 24 hours after surgery. QoR = -15 (0-150; 0 = lowest degree of satisfaction, 150 = highest degree of satisfaction).
One day
Study Arms (2)
control group
NO INTERVENTIONAll patients will receive routine monitoring ( ECG monitoring, SpO2, noninvasive blood pressure, and EtCO2) and routine anesthesia management. 20 gauge to patients IV Cannulation will be provided and isotonic fluid will be started according to the fluid calculation. General anesthesia induction 1mg midazolam IV, 2 mg/kg propofol IV, 1.5 mcg /kg fentanyl IV, 0.6 mg/kg rocuronium It will be done by giving IV. Patients will be intubated and the minimum amount of anesthesia required for maintenance alveolar Sevoflurane + 50% oxygen + 50% air will be given so that the concentration (MAC) value is 1 and 0.05 mcg/kg/min. remifentanil infusion will begin. The patients will then be released to the surgical team. After the surgical procedure is completed, all patients are given IV paracetamol 1 g 3x1, IV tenoxicam 20 mg 2x1, and IV dexamethasone 8mg will be administered 1x1. All patients will be administered IV 1mg/kg tramadol as rescue analgesic when NRS is 3 or above
pericapsuler nerve block group
ACTIVE COMPARATORall patients are given IV paracetamol 1 g 3x1, iv tenoxicam 20 mg 2x1, and IV dexmethasone 8mg will be administered 1x1. Patients in Group P will also receive a pericapsuler nerve block. All patients will be administered IV 1mg/kg tramadol as rescue analgesic when NRS is 3 or above. 4mg IV to all patients with nausea and vomiting Ondansetron will be administered. Once patients are extubated, they will be transferred to the postanesthetic care unit (PACU) for observation.
Interventions
-Ultrasound Guided pericapsuler nerve block: will be externally rotated and abducted to 45 degrees. The shoulder area will be sterilized with povidone-iodine. High-frequency linear ultrasound perpendicularly between the coracoid and the humeral head probe. The deltoid muscle, subscapular muscle and tendon, and humeral head will be identified on the ultrasound screen. With the in-plane technique, a 22 gauge, 50 millimeter (mm) simplex A peripheral nerve block needle will be used. After passing the deltoid muscle, the needle will contact the tendon of the subscapularis muscle. The needle will be slightly withdrawn and directed between the deltoid muscle and the tendon of the subscapularis muscle and a local injection consisting of will be applied.
Eligibility Criteria
You may qualify if:
- Patients who will have unilateral shoulder arthroscopy
- Patients who will receive general anesthesia
- Patients aged 18-65
- Patients with ASAI-III
- in the hospital for at least 24 hours postoperatively
You may not qualify if:
- Patients who do not want to give consent
- Patients for whom regional anesthesia is contraindicated
- Patients with ASA IV and above
- Patients with confusion
- Patients with a bad bleeding profile using anticoagulants
- Patients with infection in the area to be treated
- Emergency cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konya City Hospital
Konya, 42020, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist, the member of department of Anesthesiology, Konya City Hospital, M.D
Study Record Dates
First Submitted
December 9, 2023
First Posted
January 25, 2024
Study Start
January 26, 2024
Primary Completion
April 15, 2024
Study Completion
April 15, 2024
Last Updated
April 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share