NCT02060812

Brief Summary

Purpose: The purpose of this study is to compare the result of combined sono-guided suprascapular nerve block (SSNB) and axillary nerve block (ANB) with isolated SSNB in postoperative pain following arthroscopic rotator cuff repair. Our hypothesis was that SSNB combined ANB would show a more effective anesthesia for arthroscopic rotator cuff repair as compared with SSNB only. Methods: Forty-two patients with rotator cuff tear who had undergone arthroscopic rotator cuff repair were enrolled in this study. Among them, 21 patients were randomly allocated into group I, and received SSNB and ANB with each 10mL ropivacaine. The other 21 patients were allocated into group II, and received SSNB with 10mL ropivacaine and ANB with 10mL normal saline. Visual Analogue Scale (VAS) pain score, patient's satisfaction (SAT), and Lateral Pain Index (LPI), etc was checked at postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

8 months

First QC Date

February 10, 2014

Last Update Submit

February 11, 2014

Conditions

Keywords

ultrasound guided axillary nerve blockarthroscopic rotator cuff repairultrasound guided suprascapular nerve blockrebound phenomenon of pain

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain scale

    VAS pain score was selected from 0 to 10. 0 was no pain and 10 was severe pain that the patient had ever experienced.

    postoperative 48 hours

Secondary Outcomes (1)

  • Patient satisfaction (SAT)

    postoperative 48 hours

Other Outcomes (1)

  • lateral pain index (LPI)

    postoperative 48 hours

Study Arms (2)

Group I, SSNB & ANB

EXPERIMENTAL

21 patients were randomly allocated into group I, and received suprascapular nerve block (SSNB) and axillary nerve block (ANB) both with 10mL ropivacaine.

Procedure: Group I, SSNB & ANB

Group II, SSNB alone

PLACEBO COMPARATOR

The other 21 patients were allocated into group II, and received suprascapular nerve block (SSNB) with 10mL ropivacaine and axillary nerve block (ANB) with placebo (10mL normal saline).

Procedure: Group II, SSNB alone

Interventions

Suprascapular nerve block (SSNB) and axillary nerve block(ANB) were performed by one anesthesiologist under sono-guidance. 23 gauge spinal needle was used. SSNB was done at first and the entry site was the mid point between an anterolateral angle of acromion and medial end of scapular spine. With the linear probe, the suprascapular notch was identified and the block was performed penetrating the transverse scapular ligament because the scapular nerve and artery were located at the suprascapular notch. Just after the SSNB, ANB was performed and the entry site was the point 1.5 cm medial and 2cm inferior to posterolateral angle of acromion. With the linear probe, posterior circumflex artery was identified and the block was done at just above the artery.

Group I, SSNB & ANB

This is same as the Group I, SSNB \& ANB, but ANB was performed with placebo(10mL normal saline).

Group II, SSNB alone

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • an definite rotator cuff tear on preoperative MRI which needed repair,
  • accept an arthroscopic surgery including rotator cuff repair,
  • more than 20 years old,
  • accept preemptive regional block and PCA (patient controlled analgesia).

You may not qualify if:

  • did not underwent arthroscopic rotator cuff repair
  • stopped PCA before postoperative 48 hours due to associated side effect
  • history of previous shoulder operation or fracture,
  • a concomitant neurologic disorder around the shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 700-204, South Korea

Location

Related Publications (1)

  • Lee JJ, Kim DY, Hwang JT, Lee SS, Hwang SM, Kim GH, Jo YG. Effect of ultrasonographically guided axillary nerve block combined with suprascapular nerve block in arthroscopic rotator cuff repair: a randomized controlled trial. Arthroscopy. 2014 Aug;30(8):906-14. doi: 10.1016/j.arthro.2014.03.014. Epub 2014 May 29.

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Jung-Taek Hwang, MD, PhD

    Chuncheon Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor in department of orthopedic surgery

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 12, 2014

Study Start

November 1, 2012

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations