NCT06225089

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

January 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

December 9, 2023

Last Update Submit

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 INTERVENTION

All 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 COMPARATOR

all 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.

Drug: pericapsuler nerve block

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.

pericapsuler nerve block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations