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

Primary Purpose

Orthopedic Disorder, Shoulder Pain, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pericapsular nerve block
Suprascapular nerve block
Bupivacaine and prilocaine hydrochloride
Bupivacaine and prilocaine hydrochloride
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Orthopedic Disorder focused on measuring peng block, suprascapular nerve block, postoperative analgesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group PENG

Group SSNB

Arm Description

The investigators performed a pericapsular nerve block on that patient group for postoperative analgesia.

The investigators performed a suprascapular nerve block on that patient group for postoperative analgesia.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative 36-hour total tramadol hydrochloride consumption
This will be measured by the PCA device in the 36 hours after

Full Information

First Posted
November 28, 2022
Last Updated
December 16, 2022
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05666076
Brief Title
Peng Block or Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Artroscopy ?
Official Title
Ultrasound-guided Shoulder PENG Block Versus Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Arthroscopy; A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
September 22, 2023 (Anticipated)
Study Completion Date
November 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Shoulder Pain, Surgery, Analgesia
Keywords
peng block, suprascapular nerve block, postoperative analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group PENG
Arm Type
Active Comparator
Arm Description
The investigators performed a pericapsular nerve block on that patient group for postoperative analgesia.
Arm Title
Group SSNB
Arm Type
Active Comparator
Arm Description
The investigators performed a suprascapular nerve block on that patient group for postoperative analgesia.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve block
Intervention Description
The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.
Intervention Type
Procedure
Intervention Name(s)
Suprascapular nerve block
Intervention Description
The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia in shoulder arthroscopy.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine and prilocaine hydrochloride
Intervention Description
The investigators will perform a pericapsular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride
Intervention Type
Drug
Intervention Name(s)
Bupivacaine and prilocaine hydrochloride
Intervention Description
The investigators will perform a suprascapular nerve block on that patient group for postoperative analgesia with bupivacaine and prilocaine hydrochloride
Primary Outcome Measure Information:
Title
The primary outcome measure of the study is the patients' postoperative pain scores (NRS)
Description
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.
Time Frame
36 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative 36-hour total tramadol hydrochloride consumption
Description
This will be measured by the PCA device in the 36 hours after
Time Frame
36 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gokhan Sertcakacilar, MD
Phone
00905053130818
Email
drgokhansertcakacilar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Topcu, MD
Phone
00905437860316
Email
ibrahimtpc78@gmail.com
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gokhan Sertcakacilar
Phone
00905053130818
Email
drgokhansertcakacilar@gmail.com
First Name & Middle Initial & Last Name & Degree
Gokhan Sertcakacilar

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34871240
Citation
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.
Results Reference
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PubMed Identifier
34118263
Citation
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.
Results Reference
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Peng Block or Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Artroscopy ?

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