Comparison of Interscalene Block and Suprascapular With Axillary Block

• Sponsor: Istanbul University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04822610
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 3
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

In this study, the investigators are going to compare the analgesia effectiveness of interscalane block and suprascapular with axillary block in shoulder arthroplasties

Condition or Disease	Intervention/Treatment	Phase
Shoulder Arthroplasty; Ultrasound Guided	Procedure: interscalene block; Procedure: suprascapular block + axillary block	N/A

Detailed Description

In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied.

The first group will be get interscalene block. The second group will be get suprascapular and axillary block. The third group patient will be get no block. Afterwards, the participants will be operated under general anesthesia. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Study group - Study group- Control groupStudy group - Study group- Control group
• Masking: Single (Outcomes Assessor)
• Masking Description: open
• Primary Purpose: Treatment
• Official Title: Comparison of Analgesic Effectiveness of Ultrasound Guided Interscalene Block Versus Suprascapular With Axillary Block in Shoulder Arthroplasties
• Actual Study Start Date: Jun 30, 2021
• Actual Primary Completion Date: Jan 21, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group: interscalene block + IV PCA preop usg guided interscalene block and IV PCA	Procedure: interscalene block; peripheral nerve block
Experimental: Study group: suprascapular block + axillary block + IV PCA preop usg guided suprascapular block + axillary block and IV PCA	Procedure: suprascapular block + axillary block; peripheral nerve block
No Intervention: Control group: IV PCA no block + IV PCA

Outcome Measures

Primary Outcome Measures

1. Opioid (mg) consumption [48 hours]

   Opioid (mg) consumption

2. Measurement of postoperative pain [48 hours]

   VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

Other Outcome Measures

1. Operation time [during surgery]

   minutes

2. Hospital stay [postoperative period up to 3 days]

   days

3. Postoperatif complication [postoperative period up to 3 days]

   yes-no

4. Patient satisfaction [postoperative period up to 3 days]

   5-point Likert scale: very satisfied (= 5), relatively satisfied (= 4), fairly satisfied (= 3), relatively dissatisfied (= 2) and very dissatisfied (= 1)

5. Beck Depression Inventory (BDI) [Will be done 3 times 1- on pre-operative hospitalization 2- in the hospital after surgery 3- in the 1st month follow-up after surgery]

   0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• accepting the study protocol,

• age older than 18 years and younger than 90 years,

• undergoing shoulder arthroplasty surgery

• the American Society of Anesthesiologist (ASA) physical status of I-II-III-IV

Exclusion Criteria:

• severe respiratory distress

• patients with local anesthetic allergy

• contralateral hemidiaphragmatic parrhesia

• recurrent laryngeal nerve palsy

• infection at the injection site

• coagulation disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University, Faculty of Medicine	Istanbul	Fatih	Turkey	34093

Sponsors and Collaborators

• Istanbul University

Investigators

• Principal Investigator: Kübra Ozkan, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cho N, Kang RS, McCartney CJL, Pawa A, Costache I, Rose P, Abdallah FW. Analgesic benefits and clinical role of the posterior suprascapular nerve block in shoulder surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2020 Mar;75(3):386-394. doi: 10.1111/anae.14858. Epub 2019 Oct 3.
• Lee SM, Park SE, Nam YS, Han SH, Lee KJ, Kwon MJ, Ji JH, Choi SK, Park JS. Analgesic effectiveness of nerve block in shoulder arthroscopy: comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2573-8. doi: 10.1007/s00167-012-1950-5. Epub 2012 Mar 21.
• Park JY, Bang JY, Oh KS. Blind suprascapular and axillary nerve block for post-operative pain in arthroscopic rotator cuff surgery. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3877-3883. Epub 2016 Jan 5.
• Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.

• Responsible Party: Nur Canbolat, Principal Investigator, M.D., Istanbul University
• ClinicalTrials.gov Identifier: NCT04822610
• Other Study ID Numbers: 2020/1562
• First Posted: Mar 30, 2021
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nur Canbolat, Principal Investigator, M.D., Istanbul University: axillary block; suprascapular block

Study Results

No Results Posted as of Feb 1, 2022