Peng Block or Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Artroscopy ?

Ultrasound-guided Shoulder PENG Block Versus Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Arthroscopy; A Prospective Randomized Controlled Study

Arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. Postoperative pain management is very important in shoulder arthroplasty. Adequate pain control; mental state, nutrition, cost of care, rehabilitation, and patient satisfaction, are of great importance for the patients' recovery and contribute to a successful surgical outcome.

In this study, the investigators aimed to compare the effects of suprascapular nerve block and shoulder pericapsular nerve block, which will be performed preoperatively with ultrasound, on the level of postoperative pain in patients who will undergo shoulder arthroscopy surgery under general anesthesia.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Shoulder Pain; Surgery; Orthopedic Disorder
• Intervention / Treatment: Procedure: Pericapsular nerve block; Drug: Bupivacaine and prilocaine hydrochloride; Drug: Bupivacaine and prilocaine hydrochloride; Procedure: Suprascapular nerve block

Detailed Description

As a result of the power analysis the investigators conducted for this study, the minimum sample size was calculated as 32 people for each group, 64 people in total, at the 90% confidence interval.

64 patients who meet the inclusion criteria will be included in our study. The participants will be randomized and divided into 2 groups. Accordingly, the PENG block will be applied to 32 patients, and the suprascapular block will be applied to 32 patients.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gokhan Sertcakacilar, MD; Phone Number: 00905053130818; Email: drgokhansertcakacilar@gmail.com
• Study Contact Backup: Name: Ibrahim Topcu, MD; Phone Number: 00905437860316; Email: ibrahimtpc78@gmail.com

Study Locations

• Turkey
  • Bakirkoy
    • Istanbul, Bakirkoy, Turkey, 34147
      • Recruiting
      • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
      • Principal Investigator: Gokhan Sertcakacilar
      • Contact: Gokhan Sertcakacilar; Phone Number: 00905053130818; Email: drgokhansertcakacilar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who will have shoulder arthroscopy surgery under general anesthesia
• Ages of 18-75
• ASA I-III

Exclusion Criteria:

• Patients with deformity and pathology in the shoulder region
• Patients with known local anesthetic allergy
• Patients with BMI>35
• Patients with alcohol and substance addiction
• Patients with opioid addiction
• Patients who cannot perceive and evaluate pain, such as psychiatric illness, mental retardation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group PENG; The investigators performed a pericapsular nerve block on that patient group for postoperative analgesia.	Procedure: Pericapsular nerve block; The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.; Drug: Bupivacaine and prilocaine hydrochloride; The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride; Drug: Bupivacaine and prilocaine hydrochloride; The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride
Active Comparator: Group SSNB; The investigators performed a suprascapular nerve block on that patient group for postoperative analgesia.	Drug: Bupivacaine and prilocaine hydrochloride; The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride; Drug: Bupivacaine and prilocaine hydrochloride; The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride; Procedure: Suprascapular nerve block; The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)	Numerical rating scale (NRS) at 1, 6, 12, 18, 24, 30, and 36th hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.	36 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative 36-hour total tramadol hydrochloride consumption	This will be measured by the PCA device in the 36 hours after	36 hours postoperatively

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

General Publications

• Sun C, Zhang X, Ji X, Yu P, Cai X, Yang H. Suprascapular nerve block and axillary nerve block versus interscalene nerve block for arthroscopic shoulder surgery: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2021 Nov 5;100(44):e27661. doi: 10.1097/MD.0000000000027661.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Anticipated): September 22, 2023
• Study Completion (Anticipated): November 17, 2023

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Estimate): December 26, 2022

Study Record Updates

• Last Update Posted (Estimate): December 26, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: postoperative analgesia; suprascapular nerve block; peng block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Arthralgia; Shoulder Pain; Musculoskeletal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine; Bupivacaine
• Other Study ID Numbers: 2022-360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: From the date of publication, available data may begin. If requested, the data will be shared with the anesthetists dealing with shoulder blocks.
• IPD Sharing Time Frame: Two year within the publication date.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No