Post Surgical Pain in Arthroscopic Shoulder

• ClinicalTrials.gov Identifier: NCT04855019
• Recruitment Status: Completed
• First Posted: April 22, 2021
• Last Update Posted: November 2, 2021
• Sponsor: Namik Kemal University
• Information provided by (Responsible Party): Ayhan ŞAHİN, Namik Kemal University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Total Shoulder Arthroplasty	Procedure: shoulder periarticular injection, suprascapular and axillary nerve block	Not Applicable

Detailed Description:

This randomized trial aims to assess if a combined suprascapular-axillary nerve block (CSAB) to periarticular injection (PI) treated pain after arthroscopic shoulder surgery. Secondary endpoints included opioid consumption, discomfort associated with muscle weakness, and patient satisfaction.

sixty patients undergoing arthroscopic shoulder surgery will be randomized to receive ultrasound-guided CSAB (n = 30) or PI (n = 30). Pain intensity at rest and discomfort were recorded upon arrival in the recovery room, discharge to the ward, and at 4, 8, and 24 hours after surgery. Tramadol consumption was recorded for the first 24 hours. Patient satisfaction data will be recorded on the second postoperative day.

Using a computer-generated random allocation sequence (created by the study statistician), patients will randomly be assigned to ultrasound-guided SAB (n = 30) or PI(n = 30). Allocation numbers will be sealed in an opaque envelope opening in sequence by an independent anesthesiologist who will not assess outcomes. Outcome assessors will be blinded to treatment allocation.

After eligible patients are identified from the registry, patient charts were prospectively a blind orthopedist would collect data. Demographic data including sex, age, body mass index, surgical procedure, and complications will be recorded. Primary outcome measures were numeric rating scale pain scores and 24-hour postoperative opioid consumption. Pain scores will be recorded immediately before surgery, immediately following surgery in the postanesthesia recovery unit, and 24 hours postoperatively. Total opioid consumption will also be recorded for the first 24 hours following surgery. Secondary outcome measures included length of surgery, operating room time, perioperative anesthesia time, blood loss, hospital length of stay, and intraoperative and 30-day postoperative complication rates. Postoperative complications were further categorized as nerve-related, cardiopulmonary, and musculoskeletal (fracture or tendon rupture).

Statisticians will compare statistics between groups using a 2-sample t-test for normally distributed variables. The Wilcoxon rank-sum test will be used for non-normally distributed variables. A general linear model with correlated errors was used to account for repeated pain score assessments over time for each subject. The Fisher exact test will be used for categorical variables. Summary statistics will be reported as the mean and standard deviation for data analyzed using the 2-sample t-test and general linear models. The median and 25th and 75th percentiles will be reported for the Wilcoxon rank-sum test. The frequency (i.e., n) and percentage will be reported for data analyzed using the Fisher exact test. A P value of .05 will be designated as the threshold for statistical significance.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: prospective randomized trial, To compare the suprasacuplar-axillary nerve block combined with the periarticular injection method in shoulder arthroscopy cases.
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Combined Suprascapular and Axillary Nerve Blocks With Periarticular Injection for Analgesia in Arthroscopic Shoulder Surgery
• Actual Study Start Date: May 20, 2021
• Actual Primary Completion Date: September 15, 2021
• Actual Study Completion Date: October 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: periarticular injection group (PI); the group to be given a periarticular injection by an orthopedist	Procedure: shoulder periarticular injection, suprascapular and axillary nerve block; 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.
Active Comparator: Combined suprascapular-axillary nerve block group (CSAB); 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Change from the baseline 11 point NRS (numeric rating Scala) Scala [ Time Frame: 0 to 24 hours ]
   Possible scores range from 0 (no pain) to 10 ( worst possible pain). Change for 24 Hours.
2. Total opioid consumption, from the moment of exit from the operation to the 24th hour [ Time Frame: 0 to 24 hours ]
   Each patient will be fitted with a patient controlled analgesia (PCA) device. The total tramadol requirement for both groups will be calculated.

Secondary Outcome Measures :

1. nausea and vomiting [ Time Frame: 0 to 24 hours ]
   Data will be recorded in the postoperative period, in the form of present or not.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Turkey

Namık Kemal University

Tekirdağ, Süleymanpaşa, Turkey, 59100

Sponsors and Collaborators

Namik Kemal University

Investigators

• Study Chair: M.Cavidan ARAR; Prof.

More Information

• Responsible Party: Ayhan ŞAHİN, Principal Investigator, Namik Kemal University
• ClinicalTrials.gov Identifier: NCT04855019
• Other Study ID Numbers: Shoulder Surgery
• First Posted: April 22, 2021
• Last Update Posted: November 2, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayhan ŞAHİN, Namik Kemal University:

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