Post Surgical Pain in Arthroscopic Shoulder

NCT04855019 | Completed

• 1 other identifier: Shoulder Surgery
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative multimodal analgesia methods occupy an essential place in modern anesthesia. The postoperative results of opioid analgesia are now at the bottom of the current problems due to its side effects. Longer-acting local anesthetics are now effective agents of analgesia. Investigators aimed to compare the two routine methods. Ultrasonic nerve blocks are the most important of multimodal analgesia in modern anesthesia. Suprascapular and axillary nerve blocks are routinely used as a safe method. It is a routine method used by periarticular local anesthetic surgeons. İnvestigators decided to compare which method effectively follows these two methods with the postoperative 24 pain scale method.

Conditions

Total Shoulder Arthroplasty

Keywords

shoulder arthroplasty; suprascapular block; axillary nerve block; periarticular injection; ultrasound

Outcome Measures

Primary Outcomes (2)

• Change from the baseline 11 point NRS (numeric rating Scala) Scala

  Possible scores range from 0 (no pain) to 10 ( worst possible pain). Change for 24 Hours.

  0 to 24 hours

• Total opioid consumption, from the moment of exit from the operation to the 24th hour

  Each patient will be fitted with a patient controlled analgesia (PCA) device. The total tramadol requirement for both groups will be calculated.

  0 to 24 hours

Secondary Outcomes (1)

• nausea and vomiting

  0 to 24 hours

Study Arms (2)

periarticular injection group (PI)

ACTIVE COMPARATOR

the group to be given a periarticular injection by an orthopedist

Procedure: shoulder periarticular injection, suprascapular and axillary nerve block

Combined suprascapular-axillary nerve block group (CSAB)

ACTIVE COMPARATOR

the group in which an anesthesiologist will perform combined suprascapular axillar border block under ultrasound guidance

Procedure: shoulder periarticular injection, suprascapular and axillary nerve block

Interventions

shoulder periarticular injection, suprascapular and axillary nerve block PROCEDURE

In the PI group, a mixture of 30 ml bupivacaine 0.5% and 30 ml saline solution will be injected by the orthopedist after the wound is closed. In the CSAB group, a total of 20 ml 0.5% bupivacaine, 10 ml to the suprascapular notch, 10 ml to the axillary nerve, will be administered preoperatively by the anesthesiologist under ultrasound guidance.

Combined suprascapular-axillary nerve block group (CSAB); periarticular injection group (PI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being in the age range of 18-65
• agree to participate in the study

You may not qualify if:

• diabetic patients
• chronic opioid use
• patients with sensitivity to local anesthetics
• patients with neuropathy
• Patients who cannot use the PCA
• cases returning to open surgery

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Namık Kemal University

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

Location

Study Officials

• M.Cavidan ARAR

  Prof.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective randomized trial, To compare the suprasacuplar-axillary nerve block combined with the periarticular injection method in shoulder arthroscopy cases.

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 22, 2021
• Study Start: May 20, 2021
• Primary Completion: September 15, 2021
• Study Completion: October 1, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Locations

TU (1)