Combined Suprascapular and Axillary Nerve Blocks for Arthroscopic Shoulder Surgery

Combined Suprascapular and Axillary Nerve Blocks for Sevoflurane Consumption and Postoperative Analgesia in Arthroscopic Shoulder Surgery

Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve block adding to general anesthesia might improve the quality of postoperative analgesia. The aim of the study is to compare the subacromial local anesthetic infiltration and the suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption, postoperative analgesia and analgesic consumption.

Study Overview

• Status: Completed
• Conditions: Arthroscopic Shoulder Surgery; Suprascapular Nerve Block; Axillary Nerve Block
• Intervention / Treatment: Procedure: Subacromial infiltration; Procedure: Suprascapular nerve- axillary nerve block combination

Detailed Description

After informed consent and with ethics approval, 60 ASA 2-3 patients scheduled for elective arthroscopic shoulder surgery will be included in this study. Patient will be divided to two groups by using computer -generated list for randomization. In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure. In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia. In all patients after standard and BIS (Bi spectral index) monitorization general anesthesia will be induced with remifentanil (10mcg iv), propofol (2.5 mg/kg iv) and rocuronium (0.5mg/kg iv). After intubation, anesthesia will be maintained with 50% O2 and N2O mixture. Hemodynamic parameters, BIS values, end-tidal sevoflurane consumption will be recorded by blind investigator. Postoperative visual analog scale (VAS) values, postoperative analgesic consumption (Tramadol, patient controlled analgesia), complications will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06110
    • Derya Ozkan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American society of anesthesia physical status (ASA) 1,2 patients
• Elective arthroscopic shoulder surgery

Exclusion Criteria:

• ASA 3,4 patients
• Coagulation abnormality
• Body mass index >30
• Preexisting neurological deficit Local anesthetic allergy history Diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group A; In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure	Procedure: Subacromial infiltration; In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure
Active Comparator: Group B; In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia	Procedure: Suprascapular nerve- axillary nerve block combination; In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative VAS scores	Ranging from 0: no pain to 10: worst pain	Through postoperative period, an avarage of 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sevoflurane consumption	End tidal sevoflurane concentration values assesment during the surgery	5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding assesment	stage1: Good surgical visualization (numeric rating scale 7<), Stage 2: Moderate bleeding (numeric rating sacle =4-7), Stage 3: Severe bleeding, bad surgical visualization (numeric rating scale < 4)	5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: Derya Ozkan, Ministry of health diskapi yildirim beyazit training and research hospital

Publications and helpful links

General Publications

• Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
• Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. doi: 10.1097/00000539-199706000-00024.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Actual): February 25, 2018
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Diskapi4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No