Pericapsular Nerve Group Block in Shoulder Surgery

Sponsor
Selcuk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05940454
Collaborator
(none)
60
2
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pericapsular nerve group block
N/A

Detailed Description

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 pain to be experienced, analgesics are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Different techniques are used to numb the shoulder locally. One of these techniques is pericapsular nerve group block. In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics. Thus, it is aimed to reduce post-operative pain.

In this study, we plan to investigate how effective the pericapsular nerve group block is on postoperative pain. In this scientific study, patients will be randomly divided into two groups. Pericapsular nerve group block will be applied to one group of patients, while the other group will not be blocked. Pain medication will be administered intravenously to both groups before waking them up, and at the same time, a device called 'Patient Controlled Analgesia' (PCA) containing a very strong pain medication will be inserted in all patients in the service.

This device; It is a device that contains analgesics and gives analgesics to the patient through the vascular access according to the patient's request, and it works with the help of a button on it. When the patient feels pain, he will press the button and the device will give the medicine to the patient in a predetermined dose and time. The device records the total amount of pain medication sent in 24 hours on its screen. The amount of medication delivered by this device will be compared between patients with and without block. Thus, the effect of pericapsular nerve group block on postoperative pain will be investigated.

What are the procedures to be applied in the research? The surgery that will be applied to you is performed under general anesthesia. Pericapsular nerve group block, which is one of the pain relief methods we apply for shoulder surgery; It involves administering a local anesthetic drug with the help of a needle between the muscles in the shoulder and numbing your shoulder area.

After the blocking procedure, painful stimulus will be given and it will be checked whether you have pain and loss of sensation and what it is worth. If there is loss of feeling, the block will be considered successful.

After the evaluation of the block procedure is completed, you will be given general anesthesia, that is, you will be put to sleep. At the end of the surgery and at the 4th, 8th, 12th and 24th hours after the surgery, the severity of your pain will be evaluated and the total amount of analgesic consumed will be recorded. A scale that includes scoring pain between 0 and 10, called "NRS (numerical rating scale)" will be used. With this scale, you will be asked to give a score between 0 and 10 according to the severity of the pain. 0 points; "no pain", 5 points; moderate pain, and 10 points means "the most severe pain the patient has ever felt".

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Pericapsular Nerve Group Block in the Prevention of Postoperative Pain in Shoulder Surgery
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pericapsular nerve group block (Group P)

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
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

No Intervention: control group (Group C)

No block will be applied to patients in Group C.

Outcome Measures

Primary Outcome Measures

  1. To investigate the effect of pericapsular nerve group block on postoperative pain. [24 hours]

    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.

Secondary Outcome Measures

  1. Postoperative pain assessment is to evaluate time to first analgesia requirement, total amount of analgesic consumed, and complications. [24 hours]

    Demanded/administered analgesic ratio in PCA (patient control analgesia) device

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria:Patients scheduled for elective arthroscopic shoulder surgery under general anesthesia Patients aged 18 to 65 years American Society of Anesthesiologists (ASA) physical status value I-III patients

-

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Selcuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
EMİNE ASLANLAR, Assistant professor, Selcuk University
ClinicalTrials.gov Identifier:
NCT05940454
Other Study ID Numbers:
  • PENG
First Posted:
Jul 11, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EMİNE ASLANLAR, Assistant professor, Selcuk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023