NCT05940454

Brief Summary

Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. In order to prevent this post-operative pain, painkillers are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Many techniques are used to numb the shoulder locally. One of these techniques is the pericapsular nerve group block and it is a newly defined technique. In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics. This study will investigate how effective this block is in reducing pain associated with shoulder surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable postoperative-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 4, 2023

Last Update Submit

July 4, 2023

Conditions

Keywords

pericapsular nerve group blockpostoperative painshoulder surgery

Outcome Measures

Primary Outcomes (1)

  • To investigate the effect of pericapsular nerve group block on postoperative pain.

    Postoperative pain will be assessed using the NRS score (Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain) at 0, 4, 8, 12, and 24 hours.

    24 hours

Secondary Outcomes (1)

  • Postoperative pain assessment is to evaluate time to first analgesia requirement, total amount of analgesic consumed, and complications.

    24 hours

Study Arms (2)

Pericapsular nerve group block (Group P)

EXPERIMENTAL

Pericapsular nerve group block will be performed with 20 ml of 0.5% bupivacaine hydrochloride before general anesthesia is applied to the patients in Group P.

Procedure: Pericapsular nerve group block

control group (Group C)

NO INTERVENTION

No block will be applied to patients in Group C.

Interventions

The patient's arm is externally rotated and abducted at 45 degrees. A longitudinal linear ultrasound probe is placed between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle on it, a 50 mm needle is inserted with the "in-plane" technique. When the needle passes through the deltoid muscle and touches the subscapularis tendon, a hard bone-like tissue is felt and the needle is not advanced any further. It is noteworthy that the subscapularis tendon is very rigid and resistant to needle penetration when performing the pericapsular nerve group block. The needle tip is placed between the deltoid muscle and the subscapularis tendon and a local anesthetic drug (20 ml, %0.5 bupivacain hydrochlorur) is injected

Pericapsular nerve group block (Group P)

Eligibility Criteria

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

You may not qualify if:

  • coagulopathy,
  • neuropathy,
  • use of anticoagulants,
  • severe diabetes mellitus,
  • local anesthetic and/or opioid allergy or sensitivity,
  • a history of chronic pain,
  • pre-existing psychiatric illness,
  • can't understand pain scoring,
  • Body mass index greater than 35 kg/m2,
  • There is an infection in the body area to be blocked,
  • Continuing follow-up and treatment in the intensive care unit,
  • open shoulder surgery
  • do not approve the informed consent form
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.

    PMID: 34118263BACKGROUND
  • Ramadurai R, Bhoi D, Nagarajappa A, Amar P. Pericapsular nerve group block (PENG) at neutral position for shoulder manipulation: A feasible approach for a new indication. J Clin Anesth. 2021 Dec;75:110541. doi: 10.1016/j.jclinane.2021.110541. Epub 2021 Oct 12. No abstract available.

    PMID: 34653775BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 11, 2023

Study Start

August 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 30, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share