Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies

NCT04947007 | Completed

• 1 other identifier: 2020/1830
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The research is designed as a single-center, prospective, randomized double-blind study. The patients undergoing shoulder arthroscopy surgery in Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will be excluded. Ultrasonography (USG) guided combined suprascapular and axillary block will be performed routinely for postoperative analgesia. After the block is performed, general anesthesia will be applied. The patients will be divided into 4 groups. Three different doses of local anesthetic will be given to patients (30 cc vs 20 cc vs 10 cc). Local anesthetic dose will be the same for suprascapular and axillary blocks. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patient will be observed for postoperative nausea and vomiting, first time to mobilization, length of hospital stay, analgesic consumption and satisfaction of surgeon and patient.

Conditions

Pain, Postoperative

Keywords

suprascapular nerve block; axillary nerve block; Regional Anesthesia; Analgesic consumption; Postoperative analgesia; Numeric rating scale

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (0-10) pain scores for patients

  The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')

  48 hours

Secondary Outcomes (1)

• Opioid (mg) consumption

  postoperative period up to 48th hours.

Other Outcomes (6)

• Time of onset of narcotic analgesic need

  postoperative period up to 48th hours.

• Incidence of side effects

  postoperative period up to 48th hour

• Time until postoperative first mobilization

  Up to 48 hours

Study Arms (4)

Group 1

ACTIVE COMPARATOR

In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.

Drug: Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection

Group 2

ACTIVE COMPARATOR

In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.

Drug: Bupivacaine HCl 0.025 % in 10+10 ML Injection

Group 3

ACTIVE COMPARATOR

In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.

Drug: Bupivacaine HCl 0.025 % in 5+5 ML Injection

Group 4

ACTIVE COMPARATOR

In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.

Drug: Isotonic solution

Interventions

Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection DRUG

In this group, US guided suprascapulary and axillary block will be performed with 15 ml +15 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.

Also known as: Marcaine

Group 1

Bupivacaine HCl 0.025 % in 10+10 ML Injection DRUG

In this group, US guided suprascapulary and axillary block will be performed with 10 ml +10 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.

Also known as: Marcaine

Group 2

Bupivacaine HCl 0.025 % in 5+5 ML Injection DRUG

In this group, US guided suprascapulary and axillary block will be performed with 5 ml +5 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.

Also known as: Marcaine

Group 3

Isotonic solution DRUG

In this group, US guided suprascapulary and axillary block will be performed with isotonic solution

Also known as: serum physiologic

Group 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for total shoulder arthroscopy surgery
• Patients with American Society of Anesthesiology (ASA) Class 1-3

You may not qualify if:

• Refusal of regional anesthesia
• Infection on the local anesthetic application area
• Patients with known coagulopathy
• Known allergy against local anesthetics
• Anatomical difficulties to perform supra scapular and axillary blocks

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (4)

• Lee JJ, Kim DY, Hwang JT, Song DK, Lee HN, Jang JS, Lee SS, Hwang SM, Moon SH, Shim JH. Dexmedetomidine combined with suprascapular nerve block and axillary nerve block has a synergistic effect on relieving postoperative pain after arthroscopic rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4022-4031. doi: 10.1007/s00167-020-06288-8. Epub 2020 Sep 25.

  PMID: 32975624 BACKGROUND

• Ozkan D, Cemaloglu S, Catma FM, Akkaya T. Effects of suprascapular and axillary nerve block on postoperative pain relief sevoflurane consumption and visual clarity in arthroscopic shoulder surgery. Agri. 2020 Jan;32(1):1-7. doi: 10.14744/agri.2019.04875.

  PMID: 32030694 BACKGROUND

• Price D. Optimizing the Combined Suprascapular and Axillary Nerve (SSAX) Block. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):122. doi: 10.1097/AAP.0000000000000518. No abstract available.

  PMID: 27997490 BACKGROUND

• Marty P, Rontes O, Delbos A. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Block: Interpret With Caution. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):273-274. doi: 10.1097/AAP.0000000000000551. No abstract available.

  PMID: 28207648 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Isotonic Solutions

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Solutions; Pharmaceutical Preparations

Study Officials

• Nil R Kirsan, MD

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 1, 2021
• Study Start: July 15, 2021
• Primary Completion: February 21, 2022
• Study Completion: March 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

TU (1)