NCT03212443

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

July 4, 2017

Last Update Submit

August 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative VAS scores

    Ranging from 0: no pain to 10: worst pain

    Through postoperative period, an avarage of 30 minutes

Secondary Outcomes (1)

  • sevoflurane consumption

    5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia

Other Outcomes (1)

  • Bleeding assesment

    5th, 10th,20th,30th,40th,50th minutes after induction of anesthesia

Study Arms (2)

Group A

SHAM COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Interventions

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

Group B

In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure

Group A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derya Ozkan

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (2)

  • 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 Officials

  • Derya Ozkan

    Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 11, 2017

Study Start

August 10, 2017

Primary Completion

February 25, 2018

Study Completion

March 22, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations